Paying Attention to These Changes in the Production Supervision of Medical Devices

From May 1, the new version of China’s Measures for the Supervision and Administration of Medical Device Production and Measures for the Supervision and Administration of Medical Device Operation begins to be officially implemented.

 It is reported that the latest requirements of the new regulations on the supervision of medical device production are to comprehensively implement the filing system for medical device registrants, strictly implement the main responsibility of enterprises, simplify the requirements of relevant declaration materials and procedures, and strengthen risk management. increase penalties for illegal acts.

In the implementation of the medical device registrant system, the first is to change the current situation that medical device manufacturing enterprises need to rely on their own registration certificate before they can apply for a production license, and allow entrusted production enterprises to apply for a production license on the strength of the registration certificate of the registrant.

Second, it cancels the restriction of entrusting production record and entrusting only one enterprise to produce the same product at the same time, deletes the chapter of “entrusted production management”, and integrates the relevant requirements into the quality management system for unified management；Third, it defines the responsibilities and obligations of both the registrant and the entrusted production enterprise, stipulating that the registrant is responsible for the quality and safety of medical devices, the entrusted production enterprise is responsible for the production behavior, and the two parties are required to sign an agreement on entrusted production quality. It is clear that the entrusted production enterprise is responsible for production release, and the registrant is responsible for listing release.

Fourth, strengthen the supervision of the registrant, and clarify the inspection responsibilities, inspection methods, result disposal, investigation and evidence collection and other regulatory requirements of the registrant in the case of cross provincial entrusted production.

In terms of implementing the reform spirit of “release, management and service”, first, the provisions in the current measures on the need to submit “copy of business license” and other materials for applying for medical device production license and handling class I medical device production record have been abolished, and it is clear that the materials that can pass online verification do not need to be provided by the applicant;

Second, the time limit for the review of medical device production license application is adjusted from 30 working days to 20 working days; Third, it is stipulated that if the medical device recorder produces class I medical devices by himself, he can go through the production filing together with the product filing.

What aspects does the Measures mainly improve the means of medical device production supervision?

On the basis of the existing supervision methods and methods such as medical device production license and filing, supervision and inspection, and responsibility interviews, the supervision methods have been further enriched and improved from four aspects.

First, establish a medical device reporting system. Four forms of reporting, annual report, production product variety report, production condition change report and re-production report are stipulated, so that the supervisory department can grasp the production status of the enterprise in time and take targeted supervisory measures.

The second is to further improve the methods of supervision and inspection.

The third is to refine and clarify the information disclosure and responsibility interview system. The drug regulatory department shall disclose information such as medical device production license, filing, supervision and inspection, and administrative punishment in a timely manner in accordance with the law, so as to facilitate public inquiries and accept social supervision. If the medical device registrant, filer and entrusted manufacturing enterprise fail to take effective measures to eliminate the existing quality and safety risks of medical devices, the drug regulatory department may conduct responsibility interviews with the medical device registrant, filer, legal representative of the entrusted manufacturing enterprise or the person in charge of the enterprise.

How to strengthen risk control and punishment of illegal acts in the measures, and what punishment provisions have been added?

In terms of strengthening risk prevention and control and punishing illegal acts, first, on the basis of the emergency control measures in Article 72 of the regulations, further clarify that if the produced medical devices cause harm to human body or there is evidence that they may endanger human health, the drug regulatory department can take emergency control measures to suspend production, import, operation and use;

Second, it stipulates that the registrants, recorders and agents of imported medical devices refuse, hinder, delay or evade the overseas inspection organized by the NMPA, resulting in the failure of the inspection and the failure to confirm the effective operation of the quality management system. If there is evidence that it may endanger human health, it can be handled in accordance with the regulations; Third, implement the requirements of the Regulations, strengthen the punishment of illegal acts, and increase the corresponding punishment requirements according to the needs of supervision; Fourth, clarify the credit file and dishonest punishment system, require the establishment of credit files, and implement dishonest punishment according to the actual situation.

In addition to the legal responsibilities stipulated in the Regulations, the Measures has added two punishment clauses. One is for medical device manufacturers who fail to report the variety and relevant information of products produced in accordance with the Measures, or who stop production for more than one year and no similar products are in production, and fail to carry out necessary verification and confirmation and report to the local drug regulatory department during re-production, the drug regulatory department shall give a warning according to its duties and impose a fine of not less than 10000 yuan but not more than 50000 yuan;

Second, for those who fail to change the registration items of the production license of medical devices in accordance with the provisions of the Measures, or who fail to organize the code assignment, data upload, maintenance and update in accordance with the relevant requirements of the state for the implementation of the unique identification of medical devices, the drug regulatory department shall order them to make corrections within a time limit according to their duties. If they refuse to make corrections, they shall be fined not less than 10000 yuan but not more than 50000 yuan. If the circumstances are serious, they shall be fined not less than 50000 yuan but not more than 100000 yuan.

How should medical device registrants and recorders carry out entrusted production and product release?

If the medical device registrant or recorder entrusts the production, it shall evaluate the quality assurance ability and risk management ability of the entrusted party, sign the quality agreement and entrustment agreement with the entrusted party in accordance with the requirements of the guidelines for entrusted production quality agreement formulated by the State Food and drug administration, and supervise the entrusted party to perform the obligations agreed in the relevant agreement; The entrusted production enterprise shall organize production in accordance with laws, regulations, rules, medical device production quality management specifications, mandatory standards, product technical requirements, entrusted production quality agreement and other requirements, be responsible for the production behavior, and accept the supervision of the medical device registrant and recorder.

The entrusted production enterprise shall report the increased product varieties to the original production license or production filing department, and provide the entrusting party, the entrusted production products, the entrusted period and other information; If the increase of production products involves changes in production conditions that may affect the safety and effectiveness of products, it shall report to the original production licensing department 30 working days before the increase of production products, and the original production licensing department shall carry out on-site verification in a timely manner. In case of any change in the licensing matters, the relevant licensing changes shall be handled in accordance with the provisions.

The registrant and recorder of medical devices shall be responsible for the release of products on the market, establish the release procedures for products on the market, clarify the release standards and conditions, and review the production process records and quality inspection results of medical devices. If the standards and conditions are met, they can be listed only after being signed by the authorized release personnel. In case of entrusted production, the medical device registrant and recorder shall also review the production release documents of the entrusted production enterprise.

The entrusted production enterprise shall establish production release procedures, clarify the standards and conditions of production release, and can leave the factory only after confirming that the standards and conditions are met. Those who fail to meet the laws, regulations, rules, mandatory standards and the technical requirements of registered or filed products shall not be released from the factory or put on the market. The registrant and recorder of medical devices shall not entrust the entrusted manufacturing enterprise to release the medical devices for listing.

How shall medical device registrants, recorders and entrusted manufacturing enterprises implement the reporting system?

In order to further implement the main responsibilities of medical device registrants, recorders and entrusted production enterprises, the Measures establish a medical device reporting system and stipulate corresponding legal responsibilities. Medical device registrants, recorders and entrusted manufacturing enterprises shall implement the medical device reporting system in accordance with the provisions.

Implementing the self- inspection report system. Medical device registrants, recorders and entrusted manufacturing enterprises shall conduct self-examination on the operation of the quality management system every year, prepare self-examination reports in accordance with the requirements of the guidelines for the preparation of annual self-examination reports of medical device production quality management system, and submit self-examination reports to the local drug regulatory department before March 31 of the next year. The registrants and recorders of imported medical devices shall submit a self inspection report to the drug regulatory department of the province, autonomous region or municipality directly under the central government where the agent is located.

Implementing the product variety reporting system. A medical device manufacturer shall report the variety of products it produces to the drug regulatory department. Any increase in the variety of production products shall be reported to the original production license or production filing department. If the entrusted production is involved, the entrusting party, the entrusted production products, the entrusted period and other information shall also be provided. If a medical device manufacturer increases the production of products involving changes in production conditions that may affect the safety and effectiveness of products, it shall report to the original production licensing department 30 working days before increasing the production of products, and the original production licensing department shall carry out on-site verification in a timely manner. In case of any change in the licensing matters, the relevant licensing changes shall be handled in accordance with the provisions.

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