China has brought significant reforms in its regulatory system for pharmaceutical industry and clinical trials. In its continuous drive to improve the system, recently China’s Food and Drug Administration (CFDA) announced a major overhaul of its medical device regulations as well.

To the current regulations, China has made significant changes. Summarily, 12 articles were newly added, two were deleted and 39 were modified. These changes are expected to impact processes at many levels, although they are also being correlated with new anticipated US tariffs on medical device from China.

New regulations have been announced in the form of a draft document.

Announcement

China Med Device CEO Grace Fu announced that “Amendments to the Medical Device Supervision and Administration Regulations” is a draft document and people are invited to submit their feedback by 24 July. Final version of this document should be coming before end of this year.

Medical Device Amendments Draft

Here is the link for those interested in reviewing the Medical Device Amendments Draft document.

This document is in Chinese language. We have translated the document using google translate app. Please review the English version (translated using google translate below)

Amendments to the Regulations on the Supervision and Administration of Medical Devices (Draft for Ratification)

 

In order to deepen the reform of the examination and approval system and encourage the innovation of medical devices, the Regulations on the Supervision and Administration of Medical Devices shall be revised as follows:

 

1. Articles 8 are added as paragraphs 2, 3 and 4 respectively:

“When applying for the listing of medical devices, it shall be filed with the department in charge of drug supervision and administration or approved by the drug regulatory authority under the State Council. If the registration certificate or medical device registration certificate is obtained, it shall be the holder of the medical device listing permit.

“When the drug regulatory authority under the State Council examines and approves, it shall review the safety and effectiveness of medical devices and the ability of the applicant to ensure the safe and effective quality management of medical devices.

“The drug regulatory department under the State Council may authorize evaluation bodies and evaluation agencies that have the conditions to carry out review and approval.”

 

2. Delete the second paragraph of Article 9, paragraph 1.

Add two paragraphs as the second and third paragraphs respectively: “The product inspection report may be the self-inspection report of the medical device registration applicant or the record holder or the inspection report issued by a qualified medical device inspection agency.

“If an application for registration of a second type or third type of medical device product requires clinical evaluation, it shall also submit the clinical evaluation data of the medical device in accordance with the regulations.”

Amend the second paragraph to the fourth paragraph and amend to read: “Applicants for medical device registration and the filer should ensure that the information submitted is true, complete and traceable.”

 

3. Amend the first paragraph of Article 10 to read: “The first type of medical device products shall be filed, and the filer shall submit the filing materials to the department in charge of drug supervision and administration at the municipal level government of the local district.”

The second paragraph is amended as follows: “The overseas filer who exports the first type of medical equipment to China shall be the agent of the representative office established in China or the enterprise legal person designated in China, and submit the filing materials to the drug regulatory department of the State Council. And the competent authority of the country (region) where the record is located to permit the marketing of the medical device.”

 

4. Amend Article 11 to read: “Apply for the registration of Class II and Class III medical device products, and the applicant for registration shall submit the application for registration to the drug regulatory authority under the State Council.

“Applicants for overseas registration of exporting Class II and Class III medical devices to China shall be submitted to the Drug Administration of the State Council as an agent by their representative office established within the territory of China or an enterprise legal person designated within the territory of China. The information and the certification documents of the competent authority of the country where the applicant is registered permit the sale of the medical device. Innovative medical devices that are not listed domestically or overseas may not be submitted to the competent authority of the country (region) where the applicant is registered to allow the medical device to be listed for sale. Proof of the document.”

 

5. Article 13 adds one paragraph, as the second paragraph: “The medical supervision and administration department may use medical equipment for the treatment of rare diseases, serious life-threatening diseases, and no effective treatments for diseases and emergency medical emergencies. Conditional approval, and the relevant matters are stated in the medical device registration certificate.”

The second paragraph was changed to the third paragraph and was revised as follows: “When the drug regulatory department under the State Council considers it necessary to verify the quality management system when organizing the technical review of medical devices, it shall organize the quality management system verification.”

 

6. Add one, as Article 14: “The holder of the medical device listing permit shall perform the following obligations:

“(1) Establish a quality management system that is compatible with the product and maintain effective operation;

“(2) Formulating continuous research and risk management plans after listing and ensuring their effective implementation;

“(3) Carrying out monitoring and re-evaluation of adverse events in accordance with the law;

“(4) Establish and implement a product traceability and recall system;

“(5) Other obligations stipulated by the drug regulatory department of the State Council.

“Enterprises, institutions and individuals entrusted by the holders of medical device marketing licenses to conduct research and development, clinical trials, production and operation shall bear the responsibility stipulated by laws and regulations and agreements.”

 

7. Add one article as Article 15: “The agent of the holder of the overseas medical device listing permit shall perform the following obligations:

“(1) To handle the registration or filing of medical devices in accordance with the provisions of these Regulations;

“(2) Responsible for the liaison between the drug regulatory authority and the holder of the overseas medical device listing permit, and timely inform the holders of the overseas medical device listing permit to the relevant laws, regulations and technical requirements;

“(3) To undertake the monitoring and reporting of adverse medical events for imported medical devices sold in China, and to report to the drug regulatory authority in a timely manner the adverse medical device incidents occurring outside the country;

“(4) Responsible for product recall after the listing of medical devices, and report to the drug regulatory authority;

“(5) Assisting the drug regulatory authority to carry out inspections and violations of the holders of overseas medical device marketing licenses;

“(6) Liability for product quality and related service violations shall be jointly and severally liable with the holder of the overseas medical device listing permit;

“(7) Other obligations stipulated by the drug regulatory department of the State Council.

“The medical device registration certificate or filing certificate of the holder of the overseas medical device marketing license shall contain information such as the agent’s name, address and contact information.”

 

8. Amend Article 15 to Article 17, and the first paragraph is amended as follows: “The medical device registration certificate is valid for 5 years; if the conditional approval is registered, the drug regulatory authority under the State Council shall specify the validity period in the medical device registration certificate. If the registration period needs to be extended after the expiration of the validity period, the application for renewal registration shall be submitted to the original registration department six months before the expiration of the validity period.”

The third paragraph of the third paragraph is amended as follows: “With the conditional approval, the medical device registration certificate is not completed within the prescribed time limit.”

 

9. Change Article 17 to Article 19 and amend to read as follows: “Clinical evaluation of medical devices refers to the applicant’s clinical literature, clinical experience data, clinical trials and other information on whether the product meets the clinical scope and requirements for use. Confirmation process.

“The first type of medical device products are not required for clinical evaluation; the application for registration of the second type of medical device products does not require clinical evaluation in principle; for the registration of the third type of medical device products, clinical evaluation should be conducted. However, the following are One of the situations can be exempted from clinical evaluation:

“(1) The working mechanism is clear, the design is stereotyped, the production process is mature, and the medical devices of the same variety that have been on the market have been clinically applied for many years without any serious adverse event records, and the conventional use is not changed;

“(2) The non-clinical evaluation can prove that the medical device is safe and effective.

“For the second and third types of medical devices that are exempt from clinical evaluation, the applicant shall prove the safety and effectiveness of the product from the aspects of basic principles, structural composition, performance and scope of application.

“Developing the clinical evaluation of medical devices, according to product characteristics, clinical risks, existing clinical data, etc., through clinical trials in China or abroad, or through the analysis and evaluation of clinical literature and clinical experience data of similar medical devices The device is safe and effective.

“The third type of medical device used to support or sustain life or clinical use with high risk requires clinical trials in principle.”

 

10. Amend Article 19 to Article 21, the first paragraph is amended as follows: “If the third type of medical equipment carries out clinical trials with high risk to the human body, it shall be approved by the drug regulatory authority under the State Council. The management department shall decide whether to approve the clinical trial within 60 working days from the date of accepting the clinical trial application; if the decision is overdue, the registered applicant may conduct clinical trials. The clinical trial has a higher risk of the third type of medical treatment for the human body. The catalogue of equipment shall be formulated, adjusted and announced by the drug regulatory authority under the State Council.”

 

11. Add one, as Article 22: “For medical devices that are undergoing clinical trials for the treatment of diseases that are seriously life-threatening and have no effective treatments, preliminary observations may benefit, and meet ethical requirements, informed After consent, it can be used in other institutions for medical device clinical trials, and its safety data can be used for medical device registration applications.”

 

12. Add one as Article 27: “The holders of medical device marketing licenses may produce medical devices by themselves, or they may entrust medical device manufacturers that meet the requirements of these Regulations and have the corresponding conditions to produce medical devices.

“If the holder of the medical device marketing license produces its own medical device, it shall obtain the medical device production license or file the record in accordance with the provisions of these Regulations.

“Where a medical device is commissioned, the holder of the medical device marketing license shall be responsible for the quality of the medical device entrusted to the production, and strengthen the management of the production behavior of the trustee to ensure that it is produced according to statutory requirements. The holder of the medical device marketing license A trust agreement shall be signed with the trustee to clarify the rights, obligations and responsibilities of both parties.

“Implanted medical devices with high risks shall not be commissioned for production. The specific catalogue shall be formulated, adjusted and announced by the drug regulatory authority under the State Council.”

 

13. Amend Article 24 to Article 28 and amend to read: “The holder of the medical device marketing license shall establish and improve the quality management system that is compatible with the medical equipment produced according to the medical device production quality management norms. And to ensure its effective operation, in strict accordance with the technical requirements of the registered or filed products to organize production, to ensure that the factory medical equipment meets the mandatory standards and the technical requirements of the registered or filed products.

“The holders of medical device marketing licenses shall conduct self-inspection on the operation of the quality management system on a regular basis, and submit self-inspection reports to the drug regulatory authorities of the people’s governments of the provinces, autonomous regions and municipalities directly under the Central Government every year; among them, the overseas medical devices shall be listed on the market. A person shall submit a self-inspection report to the drug regulatory authority under the State Council through his agent.

The agent of the holder of the overseas medical device listing permit shall report the relevant agent information to the drug regulatory authority of the people’s government of the local province, autonomous region or municipality directly under the Central Government every year.”

 

14. Amend Article 25 to Article 29 and amend to read: “If the production conditions of medical devices change and no longer meet the requirements of the medical device quality management system, the holder of the medical device marketing license shall take immediate action. Corrective measures; may affect the safety and effectiveness of medical devices. The holders of medical device marketing licenses shall immediately stop production activities and report to the drug regulatory authorities of the local governments of provinces, autonomous regions and municipalities directly under the Central Government; The person shall report to the drug regulatory authority under the State Council through his agent.”

 

15. Change Article 26 to Article 30 and add one as the second paragraph: “Medical device products shall be given a unique mark. The unique identification rules for medical devices shall be formulated and promulgated by the drug regulatory authority under the State Council.”

 

16. Change Article 27 to Article 31, and add the second paragraph to the second paragraph, respectively as the first item and the second item: “(1) The name and address of the holder of the medical device listing permit and Contact information, the name, address and contact information of the agent of the overseas medical device listing permit holder;

“(2) Medical device registration certificate number or record number;”

Delete the third paragraph.

 

17. Delete Article 28.

 

18. Replace Article 30 with Article 33 and amend Article 29 in the first paragraph to Article 32.

Add one, as the second paragraph: “The second type of medical equipment that can guarantee its safety and effectiveness through routine management, no need to handle the business record. The list of the second type of medical device products that do not need to be handled for operation is listed by the Drug Administration of the State Council. The management department has made it.”

 

19. Amend Article 31 to Article 34 and amend Article 29 in the first paragraph to Article 32.

 

20.  as Article 35: “The holders of medical device marketing licenses may sell medical devices by themselves, or they may entrust medical device operating enterprises that meet the requirements of these Regulations and have the corresponding conditions to sell medical devices.

“If the medical device marketing license holder sells the medical device by himself, there is no need to apply for a medical device business license or filing, but it shall comply with the operating conditions stipulated in these Regulations.

“If the medical device is commissioned for sale, the holder of the medical device marketing license shall be responsible for the quality of the medical device that is entrusted to be sold, and strengthen the management of the business operations of the trustee to ensure that it is sold according to statutory requirements. The holder of the medical device marketing license A trust agreement shall be signed with the trustee to clarify the rights, obligations and responsibilities of both parties.”

 

21. Add one, as Article 36: “In the operation of medical devices, it shall establish and improve the quality management in accordance with the requirements of the medical device management quality management standards formulated by the drug regulatory authority under the State Council. The system is guaranteed to operate effectively.”

 

22. Change Article 32 to Article 37, and Amend the second paragraph to the following: “(3) The names of holders of medical device marketing licenses and production enterprises;”

 

23.  add one, as Article 38: “Where engaged in the sale of medical device network, it shall be the holder of the medical device listing permit or the medical device operating enterprise that obtains the medical device business license or filed according to law. Engaged in medical devices. For network sales, it shall, in accordance with regulations, file with the municipal department of the local people’s government responsible for drug supervision and management, and comply with the regulations on quality management of medical devices.

“The third-party platform for medical device network transactions shall be filed with the drug supervision and administration department of the provincial people’s government. The third-party platform provider of online transactions shall undertake the obligations of enterprise qualification review, sales behavior supervision and quality complaint handling on the platform; If an enterprise has violated the law, it shall promptly stop and immediately report to the drug supervision and administration department of the provincial people’s government; if serious violations are found, the network transaction platform service shall be immediately stopped. If the personal and property losses of others are caused, the relevant laws and regulations shall be Bear civil liability.”

 

24. Change Article 40 to Article 46 and amend it to read as follows: “Medical device operating enterprises and users shall not operate or use drugs that have not been legally registered or filed, have no certificate of conformity, and have expired, expired or eliminated medical treatment. instrument.”

 

25. Change Article 42 to Article 48 and add two paragraphs as paragraphs 3 and 4: “The medical institutions are in urgent need of clinical needs, and they need to import medical equipment and go through the import formalities in accordance with relevant state regulations.

“It is forbidden to import and sell used medical devices.”

 

26. Delete Article 45.

 

27. Change Article 47 to Article 52 and add one as the first paragraph: “The holder of the medical device marketing permit shall establish a medical device adverse event monitoring system and directly report the medical device according to the regulations. Adverse events. The holders of medical device marketing licenses shall be equipped with adverse event monitoring agencies and personnel appropriate to their products, and actively monitor adverse events for their products; if medical device adverse events or suspected adverse events are discovered, they shall be in accordance with the State Council’s drug supervision and management. The department’s regulations report to the medical device adverse event monitoring technical organization, conduct timely investigation, analysis, evaluation, actively control product risks, and report the evaluation results.”

Change the first paragraph to the second paragraph and amend it to read: “Medical device operating enterprises and users should conduct adverse event monitoring on medical devices operated or used; if medical device adverse events or suspected adverse events are discovered, medical devices should be notified in time. The holder of the listing permit shall report to the medical device adverse event monitoring technical agency in accordance with the provisions of the drug regulatory authority under the State Council.”

 

28. Change Article 51 to Article 56, and amend to read: “In any of the following circumstances, the holder of the medical device listing permit shall take the initiative to carry out re-evaluation of the listed medical device:

“(1) According to the development of scientific research, there is a change in the understanding of the safety and effectiveness of medical devices;

“(2) Monitoring and evaluation of adverse events of medical devices indicate that medical devices may be defective;

“(3) Other circumstances as required by the drug regulatory authority under the State Council for re-evaluation.

“If the holder of the medical device marketing license fails to fulfill the medical device re-evaluation obligation as required, the drug regulatory authority of the people’s government at or above the provincial level shall order the holder of the medical device listing permit to carry out re-evaluation. If necessary, the people’s government at or above the provincial level shall The supervision and management department can directly organize the re-evaluation of medical devices.

“The holder of the medical device marketing license shall, according to the results of the re-evaluation, take corresponding control measures to continuously improve the listed medical devices and make registration changes or record changes according to the regulations. The results of the re-evaluation indicate that the registered or filed medical devices are listed. If it is not guaranteed to be safe and effective, the holder of the medical device marketing license shall apply for cancellation of the medical device registration certificate or cancel the record; if the holder of the medical device marketing permit has not applied for the cancellation of the medical device registration certificate or cancel the filing, the original issuing department shall Cancel the medical device registration certificate or cancel the record, and announce it to the public. The medical device that has been cancelled or the medical device that has been cancelled may not be produced, imported, operated or used.”

 

29. Change Article 52 to Article 57, and amend to: “The holder of the medical device marketing license found that the medical device it produced does not meet the mandatory standard, the technical requirements for the registered or filed product or If there are other defects, the production shall be stopped immediately, the relevant production and operation enterprises, users and consumers shall be notified to stop production, operation and use, medical equipment that has been listed for sale shall be recalled, measures such as remediation and destruction shall be taken, relevant information shall be recorded, and relevant information shall be released. Report the medical device recall and handling to the drug regulatory authority and the health authority.

“If a medical device operating enterprise discovers that the medical device it operates has the conditions prescribed in the preceding paragraph, it shall immediately stop the operation, notify the relevant medical device listing permit holder, the operating enterprise, the user unit, the consumer, and record the suspension of operation and notification. The medical device that the holder of the medical device marketing license considers to be required to be recalled in accordance with the provisions of the preceding paragraph shall be recalled immediately.

“If the holder of the medical device listing license or the operating enterprise fails to implement the recall or stop the operation in accordance with the provisions of this Article, the department in charge of drug supervision and administration may order it to recall or stop the operation.”

 

30. Add one as Article 58: “The State establishes a system of professional medical device inspectors. Inspectors should have relevant laws, regulations and professional knowledge of medical devices, and they can be engaged in inspections after passing the examination.”

 

31. Amend Article 53 to Article 59 and amend to read as follows: “Medical equipment development activities shall be supervised and inspected by the drug regulatory department of the State Council, and medical device production activities shall be carried out by the drug supervision and administration department of the people’s government at or above the provincial level. Responsible for supervision and inspection, the medical device operation and use activities are supervised and inspected by the municipal and county-level people’s governments responsible for drug supervision and management.

“The overseas inspection of medical devices shall be organized and implemented by the drug regulatory department of the State Council.

When the department in charge of drug supervision and management supervises and inspects the development, production, operation, use, import and other activities of medical devices, it shall conduct key supervision and inspection on the following matters:

“(1) Whether to organize production in accordance with the technical requirements of registered or filed products;

“(2) Whether the quality management system remains in effective operation;

“(3) Whether the production and operation conditions continue to meet the statutory requirements.

“If necessary, the department responsible for drug supervision and management may conduct extended inspections of other relevant units and individuals that provide products or services for the development, production, operation, use, import and other activities of medical devices.”

 

32. Change Article 54 to Article 60 and add one paragraph as the second paragraph: “The department responsible for drug supervision and administration shall implement the measures of seizure and seizure according to regulations, and the period of seizure and seizure shall not exceed 30 days. If the situation is complicated, it may be extended by the person in charge of the food and drug supervision and administration department that has implemented the seizure and seizure measures, and the extension period shall not exceed 45 days.”

The third paragraph was changed to the fourth paragraph and was amended to read: “The relevant units and individuals shall cooperate with the supervision and inspection of the department in charge of drug supervision and administration, provide relevant documents and materials, and shall not conceal the relevant circumstances, and may not refuse, obstruct or evade.”

 

33. Amend Article 55 to Article 61 and amend to read: “If there are potential safety hazards in the production and operation of medical devices, and the measures are not taken in time, the department responsible for drug supervision and management may make a responsibility according to law. Decisions, rectification within a time limit, issuing a warning letter, ordering a recall, etc. Responsible for drugs that cause harm to the human body or have evidence that may endanger human health, or that seriously violate the quality management regulations of medical devices and may have a direct impact on product quality. The supervisory and administrative departments may adopt emergency control measures to suspend production, import, operation and use.”

 

34. Add one, as Article 62: “Prohibition of the production, operation and use of counterfeit medical devices.

“In one of the following circumstances, it is a counterfeit medical device:

“(1) Producing or importing medical device registration certificate or filing certificate;

“(2) posing as a medical device with a non-medical device or impersonating such a medical device with another medical device;

“(3) Using fraudulent means to obtain the medical device registration certificate or the production and import of the record certificate;

“(4) Forging or fraudulent use of other medical device registration certificates or filing vouchers, company names, production addresses, etc.”

 

35. Amend Article 56 to Article 63, the first paragraph is amended as: “The department in charge of drug supervision and administration shall strengthen the production and operation of holders of medical device marketing licenses, operating enterprises and users. The spot check and inspection of medical devices used shall not be charged for inspection fees and any other expenses, and the required expenses shall be included in the government budget of this level. The drug supervision and administration department of the people’s government at or above the provincial level shall promptly issue the medical device quality announcement according to the results of the random inspection. ”

 

36. Amend Article 57 to Article 64, and Amend the third paragraph to read: “If the party has any objection to the inspection conclusion, it may, within 7 working days from the date of receipt of the inspection conclusion, the original inspection agency. Or the medical device inspection agency determined by the drug regulatory authority under the State Council shall submit an application for re-examination. If the application for re-examination is not filed within the time limit, the party shall be deemed to have accepted the inspection conclusion. The medical device inspection agency that undertakes the re-inspection shall be prescribed by the drug regulatory authority under the State Council. The conclusion of the re-examination was made within the time limit. The re-examination conclusion is the final test conclusion.”

 

37. Amend Article 58 to Article 65 and amend to: “National standards for medical devices that may present harmful substances or arbitrarily change medical device design, raw materials and production processes and have potential safety hazards. If the inspection items and inspection methods stipulated by the industry standards cannot be inspected, the medical device inspection agency may use the supplementary inspection items and inspection methods approved by the drug regulatory authority under the State Council for inspection; the inspection conclusions obtained by using supplementary inspection items and inspection methods may As the basis for the quality of medical devices recognized by the department responsible for drug supervision and management.”

 

38. Amend Article 59 to Article 66 and amend to read: “Advertising device advertisements shall be true and lawful and shall not contain false, exaggerated or misleading content.

“The market supervision and management department shall, in accordance with the laws and administrative regulations on advertising management, supervise and inspect medical device advertisements and investigate illegal acts.”

 

39. Change Article 60 to Article 67 and amend to: “The drug regulatory department of the State Council establishes a unified medical device supervision and management information platform. The department in charge of drug supervision and management shall publish medical information in a timely manner through the information platform. Daily supervision and management information such as equipment licensing, filing, random inspection, and investigation of illegal behaviors. However, the business secrets of the parties must not be disclosed.

“The department in charge of drug supervision and management establishes credit files for holders of medical device marketing licenses, production and operation enterprises, and users, and increases the frequency of supervision and inspection of bad credit records.”

 

40. Change Article 63 to Article 70, and the first paragraph is amended as: “In any of the following circumstances, the department in charge of drug supervision and administration by the people’s government at or above the county level shall confiscate the illegal income and illegal production and operation. Medical equipment and tools, equipment, raw materials and other items used for illegal production and operation; if the value of medical equipment illegally produced and operated is less than 10,000 yuan, it shall be imposed a fine of not less than 100,000 yuan but not more than 150,000 yuan; the value of goods shall be 10,000 yuan. If the above is serious, the amount of the goods shall be 15 times or more and 30 times or less; if the circumstances are serious, the application for medical device licenses by the relevant responsible person and enterprise shall not be accepted within 5 years:

“(1) Producing or operating counterfeit medical devices;

“(2) engaging in the production of Class II and Class III medical devices without production license;

“(3) Engaged in the third type of medical device business activities without a business license.”

The second paragraph is amended as follows: “If the first case of the preceding paragraph is serious and the circumstances are serious, the original license issuing department shall revoke the medical device registration certificate, medical device production license or medical device business license.”

 

41. Change Article 64 to Article 71, and amend to: “Provide false information or take other deceptive means to obtain medical device registration certificate, medical device production license, medical device business license, large-scale medical treatment. If the equipment is configured with a permit such as a permit, the original license issuing department shall cancel the obtained license and impose a fine of not less than 100,000 yuan but not more than 150,000 yuan. The application for medical device license submitted by the relevant responsible person and the unit will not be accepted within 5 years. For the production, operation or use, the medical equipment illegally produced and operated shall be confiscated, and the value of the medical equipment illegally produced and operated shall be less than 10,000 yuan, and a fine of not less than 100,000 yuan but not more than 150,000 yuan shall be imposed; illegal production and operation The value of the medical device is more than 10,000 yuan, and the fine is not more than 15 times and 30 times the value of the goods.

“Forgery, alteration, sale, lease, lending or lending related medical device licenses shall be collected or revoked by the original license-issuing department, and the illegal gains shall be confiscated; if the illegal income is less than 10,000 yuan, a fine of not less than 100,000 yuan but not more than 150,000 yuan shall be imposed. If the illegal income is more than 10,000 yuan, the fine shall be 15 times or more and 30 times or less of the illegal income; if it constitutes a violation of public security management, the public security organ shall impose the public security management punishment according to law.”

 

42. Amend Article 65 to Article 72 and amend to read: “If the medical device production and operation enterprise fails to file the record in accordance with the provisions of these Regulations, the department responsible for drug supervision and administration at the county level or above shall be ordered to make corrections within a time limit. If the company fails to make corrections within the time limit, it shall announce to the public that the unit has not been filed, and may impose a fine of not more than 50,000 yuan.

“If false information is provided at the time of filing, the department in charge of drug supervision and administration by the people’s government at or above the county level shall publicly announce the filing unit, and have already carried out production and operation, confiscate the illegal income, illegally produce and operate medical equipment, and illegally produce and operate medical equipment. If the value of the goods is less than 10,000 yuan, and a fine of not less than 10,000 yuan but not more than 30,000 yuan; the value of the medical device that is illegally produced or operated is more than 10,000 yuan, and the fine is not more than 3 times and less than 5 times; Seriously, directly responsible personnel shall not engage in medical device production and management activities within 5 years.”

 

43. The sixty-sixth article is changed to article 73, the first paragraph is amended to read: “In any of the following circumstances, the department in charge of drug supervision and administration of the people’s government at or above the county level shall order correction and confiscate illegal production. Medical equipment operated or used; the amount of medical equipment illegally produced, operated or used is less than 10,000 yuan, and is subject to a fine of 20,000 yuan to 50,000 yuan; the value of the goods is more than 10,000 yuan, and the goods are delivered. If the circumstances are serious, the company shall be ordered to suspend production and suspend business until the original license issuing department revokes the medical device registration certificate, medical device production license, medical device business license, and cancels the medical device production record and medical device. The third-party platform for business record and medical device network transaction service shall be filed; the directly responsible personnel shall not engage in medical device production and operation activities within 5 years:

“(1) The production, operation, use of medical devices that do not meet the mandatory standards or do not meet the technical requirements for registered or filed products;

“(2) Failure to formulate post-marketing continuous research and risk management plans in accordance with regulations and ensure their effective implementation;

“(3) Failure to organize production in accordance with the technical requirements of products registered or filed, or failing to establish a quality management system in accordance with the provisions of these Regulations and maintaining effective operation;

“(4) There are data frauds and other serious illegal acts in the development, production or business activities;

“(5) Operating, using non-qualified documents, expired, invalidated, obsolete medical devices, or using counterfeit medical devices;

“(6) Importing and selling used medical devices;

“(7) The third-party platform for medical device network transactions has not fulfilled its obligations under these Regulations, and the circumstances are serious;

“(8) Failure to establish a medical device traceability system in accordance with the provisions of these Regulations and perform the traceability of medical devices;

“(9) The department in charge of drug supervision and administration shall order it to refuse to recall or stop operating medical devices after it has been ordered to carry out a recall or cease operations in accordance with the provisions of these Regulations;

“(10) Entrusting enterprises that do not have the conditions stipulated in these Regulations to produce or operate medical devices, or failing to manage the production and business operations of the trustee;

“(11) Refusing or obstructing the inspections carried out by the department in charge of drug supervision and management.”

Amend the “third item” in the second paragraph to “the fifth item”.

 

44. Change Article 67 to Article 74 and amend to read: “If one of the following circumstances occurs, the department responsible for drug supervision and administration of the people’s government at or above the county level shall be ordered to make corrections, and shall be 10,000 yuan or more. If the circumstances are serious, the company shall be ordered to suspend production and suspend business until the original license issuing department revokes the medical device production license and the medical device business license, cancels the medical device production record and medical device operation record; the directly responsible personnel shall not engage in the work within 3 years. Medical device production and operation activities:

“(1) The production conditions of medical devices have changed, no longer meet the requirements of the medical device quality management system, and have not been rectified, stopped, or reported in accordance with the provisions of these Regulations;

“(2) The production, business instructions and labels that do not comply with the medical equipment specified in these Regulations;

“(3) Failure to transport or store medical devices in accordance with medical device specifications and labeling requirements;

“(4) Transfer of medical devices that are expired, expired, eliminated or inspected for unqualified medical devices.”

 

45. Replace Article 68 with Article 75, and amend to read: “In any of the following circumstances, the department in charge of drug supervision and administration and the competent department of health and health under the people’s government at or above the county level shall be ordered according to their respective duties. Correction, give warning; refuse to correct, a fine of 5,000 yuan to 20,000 yuan; if the circumstances are serious, order to suspend production and business suspension, until the original license department revoke the medical device registration certificate, medical device business license or cancel medical device products Filing voucher:

“(1) Failure to submit the self-inspection report of the quality management system as required;

“(2) Those who have not qualified medical device listing license holders or operating enterprises to purchase medical devices;

“(3) The medical device operating enterprise or the user unit has not established and implemented the medical device purchase inspection record system in accordance with the provisions of these Regulations;

“(4) The operating enterprises engaged in the second and third types of medical device wholesale business and the third type of medical device retail business have not established and implemented the sales record system in accordance with the provisions of these Regulations;

“(5) For reusable medical devices, the medical device users are not disposed of in accordance with the provisions on disinfection and management;

“(6) The medical device user unit reuses the disposable medical device or fails to destroy the used disposable medical device according to the regulations;

“(7) For medical devices that require regular inspection, inspection, calibration, maintenance, and maintenance, the medical device users are not inspected, inspected, calibrated, maintained, maintained, and recorded in accordance with the product specifications, and analyzed and evaluated in a timely manner to ensure medical care. The device is in good condition;

“(8) The medical device user unit does not properly keep the original data of the third type of medical device purchased, or fails to record the information of the large medical device and the implanted and interventional medical device in the relevant records of the medical record;

“(9) The medical device used by the medical device has found that the medical device has no potential to stop using it, notify the maintenance, or continue to use the medical device that has not been able to meet the safety standards after being repaired;

“(10) Medical device users use large-scale medical equipment in violation of regulations, and cannot guarantee medical quality and safety;

“(11) Failure to carry out monitoring of adverse events of medical devices in accordance with the provisions of these Regulations, failure to report adverse events as required, or failure to cooperate in the investigation of adverse events conducted by the medical device adverse event monitoring technical organization and the department responsible for drug supervision and management;

“(12) If the results of re-evaluation of medical devices and the results of re-evaluation of medical devices are not carried out in accordance with the provisions of these Regulations, they shall file an application for cancellation without making a proposal, or fail to cooperate with the re-evaluation of medical devices organized by the department responsible for drug supervision and management.”

 

46. The seventy-first article shall be changed to article 78, and shall be amended as: “In violation of the regulations on the management of medical device advertisements under these Regulations, the market supervision and administration department shall comply with the laws and administrative regulations on advertising management. Give punishment.”

 

47. Add one, as Article 79: “The development, production, operation, use, import and export of medical equipment violates the provisions of these Regulations, and the holder of the medical device listing license shall bear the legal responsibility; If the enterprise, institution or individual entrusted by the listing permit holder to conduct research and development, clinical trials, production and operation activities violates relevant regulations at the same time, it shall bear corresponding responsibilities according to law.”

 

48. Add one, as Article 80: “If the agent of the holder of the overseas medical device listing permit fails to perform the relevant obligations in accordance with the provisions of these Regulations, the drug supervision and administration department of the people’s government of the province, autonomous region or municipality directly under the Central Government shall give a warning and order correction. Can be imposed a fine of not less than 30,000 yuan but not more than 100,000 yuan; if it refuses to correct, it will be fined between 100,000 yuan and 200,000 yuan, and ordered to suspend the import of relevant medical equipment; if the circumstances are serious, the institution and related responsible persons shall not be allowed for 5 years. Engaged in medical device production and operation related activities.”

 

49. Add one, as Article 81: “In violation of the provisions of these Regulations, in addition to penalties in accordance with the provisions of these Regulations, in any of the following circumstances, the person directly responsible for the unit and other directly responsible personnel shall be punished. The previous year’s income from the unit was 30% or more and 1 times fine:

“(1) Deliberately committing an illegal act or having gross negligence;

“(2) The circumstances of the illegal act are serious and of a bad nature;

“(3) Violations of the law have serious consequences.

“The holder of the medical device listing license, the production and operation enterprise and its directly responsible person in charge and other directly responsible personnel who have been revoked the license shall not apply for medical device license or engage in medical device production within 10 years from the date of the penalty decision. Business activities; if it constitutes a crime and is sentenced to a fixed-term imprisonment or more, it may not apply for a medical device license or engage in medical device production and management activities for life.

“If the hiring personnel engaged in the research, production and operation of medical equipment violates the provisions of the second paragraph of this Article, the department in charge of drug supervision and administration by the people’s government at or above the county level shall order the suspension of production or suspension of business or the suspension of the permit.”

 

50. Replace Article 72 with Article 82 and amend to read: “The medical device technical evaluation agency, the medical device adverse event monitoring technology organization, and the medical device quality management system inspection technical organization have not fulfilled the provisions of these Regulations. Responsibilities, causing major mistakes in the inspection, monitoring, and quality management system inspections, or causing serious consequences, the department responsible for drug supervision and administration at the county level or above shall be ordered to correct, notify criticism, and give warning; if serious consequences are caused, The directly responsible supervisors and other directly responsible personnel shall be given disciplinary actions for downgrading, dismissal or expulsion according to law.”

 

51. Replace Article 73 with Article 83 and amend to read: “The department in charge of drug supervision and administration, the competent department of health and health and its staff shall strictly follow the types and scope of punishments stipulated in these Regulations, The nature of the illegal act and the specific circumstances shall be exercised by the administrative punishment. The specific measures shall be formulated by the drug regulatory authority under the State Council and the competent health authority in accordance with their respective responsibilities.”

 

52. Replace Article 76 with Article 86 and add to the meaning of the terms of the regulations: “The directly responsible person in charge refers to the legal representative or principal responsible person, as well as the quality management personnel and other responsible medical equipment. Personnel who develop, produce, operate, and use event management.”

 

53. Replace Article 77 with Article 87 and amend it to: “The registration of medical device products can be charged, and the supervision of medical device production sites and product varieties can be charged on an annual basis. The specific charging items and standards are respectively It shall be formulated by the competent department of finance and price of the State Council in accordance with relevant state regulations.”

 

54. Amend the “registrant” in Article 14 to “the holder of the medical device marketing license”; change the “production enterprise” in Article 38 to “the holder of the medical device marketing license” Amend the “Medical Device Production and Management Enterprise” in Article 50 to “Medical Device Listing License Holder, Production and Operation Enterprise”.

 

55. Articles 3, 1 and 3, 4, 6, 12, 13, 13, 16 and 17, The “Food and Drug Supervision and Administration Department” in Articles 18, 19, 22, 26, 32, 62 and 78 was amended to Drug regulatory authority”.

Article 3, paragraph 2, Article 21, Article 30, Article 31, Article 39, Article 47, paragraph 2, Article 48, paragraph 2, Article 49, paragraph 1, paragraph 50, article 54, paragraphs 1 and 2, article 57, paragraph 2, article 61, article 69, seventieth The “Food and Drug Supervision and Administration Department” in the four articles was revised to “the department responsible for drug supervision and management”.

Amend the “Food and Drug Supervision and Administration Department of the State Council” in Articles 43, 38, 57 and 60 to “the drug regulatory department of the State Council”.

Amend the “Food and Drug Supervision and Administration Department of the Municipal People’s Government with Districts” in Article 43 to “the department responsible for drug supervision and administration at the municipal level government of the district”.

Amend the “Food and Drug Supervision and Administration Department of the People’s Government at or above the Provincial Level” in Article 49 to “the drug supervision and administration department of the people’s government at or above the provincial level”.

 

56. Articles 6, 18, 19, 34, 35, 39, 48, 49, and The “Administrative Departments for Health and Family Planning” in Articles 56, 63, and 78 were revised to “Health and Health Competent Authorities”.

This amendment shall come into force as of the date of promulgation.

The Regulations on the Supervision and Administration of Medical Devices shall be revised accordingly and re-announced in accordance with this Decision.

Submission of Feedback

Those interested in submitting their feedback to CFDA, can utilize 3 different ways as suggested by this Chinese Govt notification.

This document is also in Chinese language and its translation by google is being presented below.

In order to enhance the openness and transparency of legislation and improve the quality of legislation, the General Administration of Market Supervision has submitted to the State Council for review of the “Amendment of the Regulations on the Supervision and Administration of Medical Devices (Draft for Review)” and its explanations, so as to solicit opinions from all sectors of society. The public can log on to the official website of the Ministry of Justice, the China Legal Service Network, the Chinese government legal information network, and pay attention to the Ministry of Justice WeChat public account to view the draft for review and its explanation. Relevant units and people from all walks of life can submit their opinions in the following three ways before July 24, 2018:

1. Log in to the China Legal Service Network (www.12348.gov.cn) or the Chinese Government Legal Information Network (www.chinalaw.gov.cn) and enter the “Legislative Comments Collection” section of the main menu of the homepage to make comments.

2. Send the comments by letter to: Department of Education, Culture, Law and Welfare, Ministry of Justice, No. 6 Chaoyangmen South Street, Chaoyang District, Beijing (postal code: 100020), and please indicate on the envelope that “medical device supervision and management regulations solicit opinions” Typeface.

3. Send the comments by email to: ylqx2018@chinalaw.gov.cn

Disclaimer

All translation referred by google or any other tool have not been verified by Credevo. All readers are advised to exercise caution and verify translation before utilizing given translations.

 

Leave a Reply

Your email address will not be published. Required fields are marked *

You may use these HTML tags and attributes:

<a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>