Registration inspection is a mandatory inspection procedure before the registration of the second and third types of medical device products. Since the medical device is supervised by law, it has always played an important role as a necessary procedure for product registration and marketing. However, since the "Medical Device Supervision" After the release of the Management Regulations (Draft for Review) (hereinafter referred to as the "Regulations for Review"), there have been new trends in the development of medical device registration and inspection, which has attracted industry attention. The second paragraph of Article 9 of the "Regulations for review" stipulates that the inspection report of a medical device can be the self-inspection report of the medical device registration applicant or the filing person; it can also be an inspection issued by a qualified medical device inspection agency to carry out the inspection. report. According to this regulation, the medical device registration and inspection system will face major changes.

Current status and problems of medical device registration and inspection

The implementation of the medical device registration and inspection system originated from the "Administrative Measures for the Registration of Medical Device Products" implemented in 1996. The Measures stipulate that the Type 2 and Type 3 medical devices must be issued a type test report by an approved medical device inspection agency before they are put on the market. The first "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Regulations") implemented in 2000 and the 2000 version of the "Administrative Measures on Medical Device Registration" initially laid the embryonic form of the medical device inspection system in terms of content. Since then, the "Measures for the Administration of Medical Device Registration" used the term "registration testing" for the first time in the regulatory provisions when it was revised in 2004, and detailed provisions of the medical device registration testing institutions, Procedures, basis, and conditions for exemption from registration testing during the first registration and re-registration. Since then, the legal status of the medical device inspection system has been strengthened. As a prerequisite procedure for clinical trials and registration applications, registration testing has been further consolidated in the product life cycle management. After the 2014 "Regulations" were revised for the first time, Articles 9, 10, and 11 stipulated the self-inspection report and inspection report that should be submitted during the registration process of the first, second, and third categories of medical devices. In the "Administrative Measures for Medical Device Registration" revised in the same year, Article 16 also has specific provisions on the registration and inspection of medical devices: "Applying for the second and third categories of medical device registration shall be subject to registration inspection. Medical device inspection institutions shall comply with product technical requirements Registration and inspection of related products." Compared with the 2004 version of the "Administrative Measures for Medical Device Registration", the medical device registration and inspection system has new changes: First, the registration inspection is changed to registration inspection, and it is stipulated in the product technical requirements at the same time. Chapter Three; The second is that product technical requirements become the basis for registration inspection. The concept of product technical requirements was first proposed in 2014, replacing the previous product registration standards and keeping them in line with international practices; third, it is emphasized that not only relevant technical information and product technical requirements must be provided during registration inspection, but also registration inspection samples are emphasized. The production should meet the relevant requirements of the medical device quality management system.

Although the medical device registration and inspection system has played a certain role in long-term practice, with the development of the medical device industry, its shortcomings have gradually emerged. This is mainly manifested in the three major problems of insufficient inspection capabilities of inspection agencies, difficulties in the development of third-party inspection agencies, and insufficient marketization of inspection services.

Insufficient inspection capabilities of medical device inspection institutions

Due to the compulsory registration and inspection, all the second and third types of medical device products must undergo registration inspection before registration, but the limited number of existing medical device inspection institutions cannot meet the growing inspection needs. As of July 2018, there are only 54 medical device inspection institutions at all levels and types in China, 11 provincial medical device inspection institutions independent of food and drug inspection institutions, and 19 food and drug inspection institutions have added brands; There are also 14 medical device inspection institutions outside the drug inspection system. According to the medical device registration work report issued by the State Drug Administration, it can be seen that these inspection agencies have to undertake a huge amount of inspection tasks every year. In addition to the registration and inspection tasks, these inspection institutions also undertake some tasks such as technical review and supervision and random inspection. Therefore, these inspection agencies are basically overloaded throughout the year. The inspection expertise, inspection fields, and inspection capabilities of these inspection institutions are different. Enterprises need to independently select inspection institutions for inspection according to their own product categories. Due to time and business scope constraints, companies simply cannot successfully complete the registration inspection according to their own wishes.

The development of third-party inspection agencies is struggling

Judging from the development history of the medical device registration and inspection system, a qualified medical device inspection agency has always been required to be responsible for registration and inspection. The "qualification" here before 2014 refers to the joint approval of the State Council's drug regulatory authority and the State Council's quality and technical supervision department; after 2014, it refers to the joint approval of the State Council's certification and accreditation management department and the State Council's food and drug regulatory department Identified. The accreditation conditions refer to the requirements of both "Qualification Accreditation Conditions for Inspection and Testing Institutions" and "Qualification Accreditation Conditions for Medical Device Inspection Institutions". It should be said that qualified institutions include not only the inspection institutions affiliated to the drug supervision and administration department, but also some third-party inspection institutions. However, from the practice of medical device registration and inspection, the registration and inspection of medical devices has always been undertaken by the inspection agency under the drug regulatory authority, and the inspection report issued by the third-party inspection agency is difficult to be recognized in the process of product registration and filing. This "dilemma" faced by third-party inspection agencies and the "burden" faced by inspection agencies affiliated to government departments seem to be contradictory.

Insufficient marketization of medical device testing and inspection services

Medical device testing is essentially a technical evaluation activity, which can be marketed. Whoever has high service efficiency and high technical level will have a competitive advantage in the market. However, looking at the entire history of medical device testing and inspection, the level of marketization is very low, which is mainly reflected in: (1) The supply and demand mechanism is distorted, medical device registration and inspection activities are not open to the society, and the inspection reports issued by third-party inspection agencies are few. It is used for product registration; (2) The price mechanism is absent. Although there is a commercial commissioned inspection, there is no market price mechanism for testing and inspection services on the whole; (3) The market competition is insufficient, and the medical device inspection institutions within the system are affected. Too much "protection", the overall strength of social third-party inspection agencies is weak, and benign market competition has not formed; (4) The market efficiency is not high, and the inspection agencies that undertake medical device registration and inspection are ineffective under the heavy tasks. , Resulting in too many products to be inspected and long-term queues of enterprises. The third-party inspection agency lacks business resources, lacks market contribution, and the overall inspection service market is inefficient.

Four dimensions of reforming the medical device registration and inspection system

In the medical device registration and inspection system, whether the main responsibility of the enterprise is fulfilled, whether the government-enterprise relationship between the inspection agency and the enterprise is reasonable, how the market demand for medical device inspection services is met, and what effective international experience other countries and regions have, are the innovations The four thinking dimensions of the system.

Principal responsibility

In the system reform, the key is to distinguish the responsibilities of relevant subjects within the system. Since the establishment of the medical device registration inspection system, mandatory registration inspections have been mainly completed by the medical device inspection institutions affiliated to the original drug regulatory authority. The original intention of this arrangement is to take into account that under the previous situation where the overall social integrity was insufficient and the industry development level was not high, the company’s own inspection capabilities and inspection conditions could not meet the requirements, and the strength of third-party inspection agencies in the society was still very weak. Selecting an approved medical device inspection agency for inspection during product registration was a practice in line with national conditions at that time. However, with the development of society and the medical device industry, the improvement of corporate self-inspection capabilities and third-party inspection capabilities, and the acceleration of the construction of a social credibility system, the original institutional arrangements must be re-examined.

In the medical device registration and inspection system, the registration management department performs the main responsibilities of quality supervision and technical review, and the registration applicant should perform its due responsibilities as the main body to push the product to the market. From the perspective of the full life cycle of medical devices, the registration inspection is a link in the process of medical device companies from product design and development to promotion and application. It is for companies to verify the safety and effectiveness of the product before clinical evaluation. Reported behavior. Therefore, registration inspection is a task that enterprises should complete themselves before launching their products on the market. The enterprise is the beneficiary of the product listing, but also the responsible party. Therefore, registration inspection should become the main responsibility of the enterprise, not the responsibility of the medical device inspection agency. To sum up, it is the prerequisite for optimizing the medical device registration and inspection system that the registration applicant completes the registration inspection task and clearly defines the main responsibility of the enterprise in the medical device registration inspection.

Government-enterprise relationship

From the perspective of administrative law, the registration and approval of the second and third categories of medical device products is an act of administrative licensing. Applicants for medical device registration as administrative license applicants must apply in accordance with the law and ensure the authenticity and legality of the application materials, such as applying for registration inspection, passing clinical evaluation and submitting true and legal product registration application materials. The supervisory department is the acceptor of the administrative license application and is responsible for the review and approval of the administrative license. Through technical review activities, it is necessary to evaluate whether the applicant's materials comply with the regulations and standards, and whether the product is safe and effective. In this administrative licensing legal relationship, the medical device registration applicant and the licensing department are the most important parties. The boundaries of their rights and obligations are very clear, and the administrative licensing department cannot perform offside the obligations that should be performed by the applicant, otherwise it will lose fairness and credibility.

A benign government-enterprise relationship should have clear responsibilities and complement each other. In contrast to the relationship between the various subjects in the medical device registration and inspection, the biggest problem is the non-discrimination of government and enterprise. After the institutional reform, the institutions currently engaged in the registration and inspection of medical devices are basically public institutions affiliated to the market supervision and management department, so they are regarded as part of the registration licensing department. These inspection agencies are engaged in registered inspections, and they are also regarded as the government doing what enterprises should do. In order to successfully pass the registration inspection, some registration applicants do not hesitate to cheat, do not produce samples according to the quality management system or even change the inspection samples at will. After the product goes on the market, registration inspection has also become an excuse for companies to evade responsibility. Therefore, the distorted government-enterprise relationship should be corrected in time, and the status of the medical device inspection agency in the registration inspection should be re-examined.

Market demand

In recent years, the medical device industry has gradually become an eye-catching section of the health industry. The rapid development trend of the industry and the low marketization of inspection services have formed a sharp contradiction. A steady stream of new products require registration and inspection, and the renewal of products already on the market also requires registration and inspection. This huge market demand cannot be met by existing inspection agencies. The stagnant inspection efficiency and long waiting time have affected the pace of listing of the company's products. To meet the growing demand, more social third-party inspection agencies must be activated.

In 2014, the "Several Opinions on Accelerating the Development of the Science and Technology Service Industry" issued by the State Council required that “persist in deepening reform, insist on innovation-driven, insist on market orientation, and insist on open cooperation” as the basic principles for the development of science and technology service industry including inspection system . Among them, "adhere to market orientation" is the key to reversing excessive administrativeization. The long-term development of medical device inspection institutions should be re-examined from the perspectives of industry development needs, international development trends, and inspection service markets.

International experience

There is no concept of registration inspection in the regulations of major market countries and regions for medical devices such as the European Union and the United States. The EU’s "European Parliament and Council Regulations on Medical Devices (2017/745)" and "European Parliament and Council Regulations on In Vitro Diagnostic Devices (2017/746)" do not specify that the certification process requires the provision of product inspection reports, which are in the appendix of the regulations Part II Technical Documents stipulates that manufacturers need to provide certification information that meets the general safety and performance requirements, including related documents such as schemes, confirmations and verifications, such as all verification, confirmation test results and analysis documents, etc., to prove that the product meets the general safety and performance requirements. Performance requirements. In the actual operation process, if the manufacturer does not have the ability to confirm and verify, or involves more critical and complex test items of the product, the manufacturer will entrust a third-party testing agency to conduct the test, and the third-party testing agency must have a good laboratory practice (GLP) ) Or "Testing and Calibration Laboratory Competency Accreditation Criteria" (ISO/IEC17025) laboratory.

In the United States, most products are approved for marketing through the premarket notification (PMN) or 510(k) procedure. The materials required by regulations include biocompatibility testing, electromagnetic compatibility testing, performance testing, etc. These materials can be The manufacturer’s self-inspection report can also be an inspection report issued by a GLP-qualified laboratory. Accepting the self-inspection report of the enterprise or the test report of the third-party inspection agency in the product registration process is a method recognized by most countries or regions in the world, and it has a good reference significance.

Suggestions on reforming the registration and inspection system for medical devices

The reform of the medical device registration and inspection system must not only give full play to the enthusiasm of enterprises to make them perform their main responsibilities, but also urge inspection agencies to change their roles and transform them. Therefore, taking self-inspection and entrusted inspection as the two major supports of the registration inspection system, and promoting the formation of the marketization of medical device inspection services on the premise of ensuring the win-win situation of both the enterprise and the inspection agency, is the inevitable choice to innovate the medical device registration inspection system .

Activate the vitality of business entities: self-inspection

At the beginning of the establishment of the medical device registration and inspection system in 1996, companies were required to compulsory registration and inspection when applying for product registration, which was done by government-affiliated inspection agencies rather than by the company. This was based on the current status of the medical device industry and the level of integrity of the company at that time. of. After more than 20 years of development, the status quo of the entire medical device industry is now different from what it used to be. With the rapid development of the medical device industry and the improvement of their own capabilities, some companies have been able to independently complete product verification work. Therefore, the right to verify the safety and effectiveness of the product should now be returned to the enterprise by the inspection agency.

The essence of medical device registration inspection is to use product technical requirements and related standards to prove whether the product meets all the requirements of these technical specifications. It is an integral part of the scope of enterprise product design verification. The verification of product design is a part of the enterprise's R&D and design, and it is still the work that the enterprise itself must carry out. In fact, there are regulations that allow companies to submit self-inspection reports when they put their products on the market. As stipulated in the first paragraph of Article 10 of the current "Regulations", the inspection report submitted during the filing of the first-class medical device product may be the self-inspection report of the filing person. Now it is necessary to extend the self-inspection report to the registration of the second and third categories of medical devices, and allow conditional companies to self-inspect and submit a self-inspection report to prove the safety and effectiveness of the product.

After the registration and inspection system is reformed, enterprises are allowed to submit self-inspection reports. For some foreign companies and large state-owned enterprises with strong inspection conditions and capabilities, self-inspection can be completed. Most in vitro diagnostic reagent companies can also submit a self-inspection report to participate in the registration application. The phenomenon of waiting in line for inspection for a long time will be significantly reduced, which can save time and speed up the product launch process. For medical device companies that do not have the conditions and capabilities for self-inspection temporarily, they can select qualified medical device inspection institutions with good service attitudes, strong technical capabilities, and high inspection efficiency through entrusted inspections to participate in the products.