Depth｜Consolidate and absorb the reform achievements, improve the registration and filing system, and welcome new regulations for the management of medical device registration and filing

On August 31, the State Administration for Market Regulation issued the "Administrative Measures for the Registration and Filing of Medical Devices" (hereinafter referred to as the "Measures") and the "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents")

The newly revised "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") have been formally implemented on June 1 this year

The issuance of the regulations of the two departments marked the opening of a new chapter of the medical device registration and filing management system

Strengthen the main responsibility and refine the registration requirements

The "Measures" implement the legislative spirit of the "Regulations", from fully implementing the medical device registrant and filing system, encouraging the innovative development of medical devices, improving technical requirements such as clinical evaluation, and increasing penalties for illegal activities, and imposes restrictions on medical device registration.

After the implementation of the newly revised "Regulations", the medical device registrant and recorder system will be implemented nationwide as the core medical device supervision system

The "Measures" fully implement the medical device registrant and recorder system, clarify that the medical device registrant and recorder should strengthen the quality management of the whole life cycle of medical devices, and the safety and Responsibility for effectiveness and quality controllability shall be assumed in accordance with the law

Product development is a key link before medical device product registration, which is directly related to the safety, effectiveness and quality controllability of medical device products

Regarding the development of medical devices, the "Measures" also pointed out that non-clinical research on medical devices should be carried out in accordance with the scope of product application and technical characteristics

Encourage innovation and development, optimize management procedures

Innovation is the first driving force leading the development of the medical device industry

At the same time, the "Measures" summarized the reform results of medical device review and approval in recent years, added a special chapter on special registration procedures, incorporated the special registration procedures implemented in recent years, such as innovative product registration procedures, priority registration procedures, and emergency registration procedures, and clarified them.

The "Measures" also summarized the experience of conducting emergency approval of medical devices in the prevention and control of the new crown pneumonia epidemic

In addition, the "Measures" also detailed the scope of conditional approval, risk management and other related requirements

Optimize clinical evaluation and improve supervision science

The medical device registration process is the process of reviewing the safety, effectiveness, and quality controllability of the products to be marketed

The “Measures” adjusted the relevant requirements for the clinical evaluation of medical devices, and stipulated that the clinical evaluation of medical devices can be carried out according to the product characteristics, clinical risks, and existing clinical data.

Due to the particularity of in-vitro diagnostic reagents, the "In-Vitro Diagnostic Reagents Registration and Filing Management Measures" covers the definition of clinical evaluation of in-vitro diagnostic reagents, the path of clinical evaluation and clinical trials, the exemption from clinical trials, the requirements for clinical evaluation data, etc.

The "Measures" implement the "Implicit License" requirements for clinical trial approval in the "Regulations", "A clinical trial application shall be approved within 60 days from the date of acceptance of the application, and be notified through the website of the National Bureau of Device Evaluation Center.

At the same time, the "Measures" also include extended clinical trials, stipulating that medical devices that are undergoing clinical trials for the treatment of serious life-threatening diseases without effective treatments may benefit patients through medical observation.
After review and informed consent, it can be used free of charge for other patients with the same condition in the institution that conducts medical device clinical trials, and its safety data can be used for medical device registration applications
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Enriching the supervision methods and perfecting the supervision system

The "Measures" implement the "four most stringent" requirements, clarify the responsibilities of the National Food and Drug Administration, the technical institutions of the National Food and Drug Administration, and the provincial food and drug regulatory bureaus, give full play to the strength of regulatory agencies at all levels, strengthen the supervision of medical devices after filing, and clarify the extension Supervision measures such as inspections, credit files of clinical trial institutions, and responsibility interviews
.

The "Measures" stipulate that the drug regulatory department should strengthen the supervision and inspection of medical device research and development activities, and may conduct extended inspections of units and individuals that provide products or services for medical device research and development when necessary
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Not only that, the drug regulatory authority may conduct on-site inspections on the authenticity, accuracy, completeness, standardization, and traceability of clinical trials if deemed necessary
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The "Measures" also clarified the relevant requirements and key content of the quality management system verification carried out by the provincial drug regulatory authorities, and put forward the requirement that the registered quality management system verification should avoid repeated inspections, and reduce the burden on enterprises
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It is worthy of the industry’s attention that the “Measures” abolished the review procedure for the conclusion of disapproval of registration, and advanced the disapproval of the disapproval of registration to the review link-during the review period of the medical device registration application, the review conclusion was rejected If the technical review agency should inform the applicant of the reasons for disapproval, the applicant can raise an objection to the technical review agency within 15 days, and the content of the objection is limited to the original application and the original application materials
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This has further improved the medical device registration system and optimized process management
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