NMPA：Interpretation of Measures for the Supervision and Administration of Medical Device Operation
I.What Is the General Idea and Principles of Revision in the Medical Device Operation Supervision Management Approach (hereinafter referred to as the operation approach)?
In the overall idea of the revision, the main four points are as follows: first, the implementation of the medical device registrant and the record holder system, strengthening their responsibilities for quality and safety throughout the life cycle. Second, we strictly put into practice the reform spirit of ” streamlining the government, delegating power, and improving government services” and simplify the requirements of relevant declaration data and procedures.
The new Operational Approach adheres to the following revised principles: first, it adheres to the classification management principle. The operation of the first class of medical devices does not require a license and recordation, and the operation of the second class of medical devices is subject to recordation management. Medical devices are subject to licensing management. The second is adherence to the principles of corporate subject responsibility. In order to highlight the corporate operation link responsibility, it is required that medical device operation enterprises should follow the requirements of laws and regulations and medical device operation quality management practices, establish a quality management system and quality control measures covering the whole process of quality management, and make relevant records and ensure that the operating conditions and operating activities continuously meet the requirements. Third, adherence to strict regulatory principles. Through comprehensive use of the system of spot check inspection, flight inspection, Responsibility Interview, safety warning, credit profile and so on, we enrich the regulatory measures and improve the means of regulation, so as to promote the implementation of regulatory responsibilities. Fourth, adhere to the principle of traceability. It is stipulated that enterprises should establish and implement a purchase inspection record system. Enterprises engaged in the wholesale business of Class II and Class III medical devices and the retail business of Class III medical devices shall establish a sales record system.
II.What are the requirements of the Operation Approach on the quality management of enterprise operations?
On the one hand, the “Operation Measures” further strengthens the quality responsibility of enterprises. It is required that enterprises engaged in medical device business should establish a quality management system and quality control measures covering the whole process of procurement, acceptance, storage, sales, transportation, after-sales service, etc. Relevant records to ensure that operating conditions and operating activities continue to meet the requirements. At the same time, medical device operation enterprises should establish a system of quality management self- inspection, in accordance with medical device operation quality management standard requirements for self -inspection, and submit a previous year’s self-inspection report to the department responsible for drug supervision and management at the county level of the city in the previous year by 31 March each year. On the other hand, it pays more attention to the quality management of the whole process of operation. First, it is required that medical device operators should purchase medical devices from legally qualified medical device registrants, filers, and operators, strictly control the qualification review of procurement and sales, and ensure the legal circulation of medical devices. The second is to highlight the record requirements of the inspection and sales link of the incoming, guarantee the traceability of the products, and should execute the medical device unique identification system in accordance with the relevant national regulations. Third, the storage and transportation requirements for low-temperature, refrigerated medical devices are emphasized to ensure the quality of product transportation. The fourth is to put forward the requirements on the after-sales service of the operational enterprise to ensure the use of the products is safe.
III.What are the initiatives to strengthen regulation through the Operation Approach?
The new Operation Approach reinforces regulation through measures such as: First, the implementation of categorical grading management. Drug surveillance and administration implement categorical hierarchical management and dynamically adjust according to the quality management of medical device operation enterprises and the extent of risk to the medical device products operated. The departments responsible for drug supervision and administration at the city and county levels divided into districts shall formulate annual inspection plans, clarify the focus of supervision, inspection frequency and coverage, and organize their implementation. The third is to carry out extended inspection. According to the needs of medical device quality and safety risk prevention and control, the drug regulatory department may conduct extended inspections of other relevant units and individuals that provide products or services for medical device business activities. Fourth, risk consultation and judgment. The drug supervision and management department shall conduct regular risk consultations and judgments based on the supervision and inspection, product sampling inspection, adverse event monitoring, complaints and reports, administrative penalties, etc., and do a good job in the investigation and prevention and control of medical device quality and safety hidden dangers. The fifth is the construction of credit files. The department in charge of drug supervision and administration at the city level with districts shall establish and update the credit files of medical device operating enterprises within their jurisdiction in a timely manner.
IV.What is the difference between wholesale and retail sales of medical devices, and what is the regulation on sales of medical devices by medical device registrars and applicants?
The distinguishing point between wholesale and retail sales of medical devices mainly lies in the different selling objects. Medical device wholesale, means the medical device operation behavior of selling a medical device to a medical device producer, medical device operation firm, medical device use unit, or other unit with reasonable use demand.
Medical device registrants and filers can sell their registered and filed medical devices by themselves, or they can entrust medical device business enterprises to sell them. If a medical device registrant or filing person commissioned for sale, it shall entrust a qualified medical device operating enterprise and sign an entrustment agreement to clarify the rights and obligations of both parties.
V.What’re the measures of the reform spirt in “ streamlining the government, delegating power, and improving government services“
One is the abolition of the provisions of taking over the operation licence and submitting the copies of business license and other certified materials in the filing. For those who simultaneously apply for the third type of operation licence and go through the second type of operation filing process, submit one information, and complete the site verification regulation at the same time. A second type of medical device for which a third type medical device operation license has been issued is exempt from submission. The second is to review the application materials within the original 30 working days, and adjust it to make a decision within 20 working days from the date of acceptance, shortening the processing time limit. The third is that Class II medical devices whose product safety and effectiveness are not affected by the circulation process can be exempted from business filing. NMPA has formulated and announced 13 products. For medical device registrants and filers who sell their registered and filed medical devices at their residence or production address, as well as institutions engaged in the storage, allocation and supply of non-profit contraceptive medical devices, they do not need to apply for business licenses or business filings. Fourth, if the license is lost, it will be reissued, and the requirement to publish the loss statement on the media designated by the original license-issuing department has been cancelled.
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