From approval to regulation | What is the change in China's medical device regulatory system?
Medical Network July 12 In 1989, China began to introduce the concept of market access for medical devices. Medical devices and new products require administrative review before they can be listed. In 1992, with reference to the European regulatory model, China initiated the certification of medical device products. In 1996, the former State Administration of Medicine issued the “Regulations on the Registration of Medical Device Products”, which officially stipulated that unregistered medical devices should not enter the market. In 2000, the State Council promulgated the Regulations on the Supervision and Administration of Medical Devices (No. 276 of the State Council) as China. The special administrative regulations clearly stipulate the implementation of the medical device registration management system, and China's medical device supervision has entered a new stage of development.
China's medical device supervision model draws on the regulatory experience of the United States and the European Union. It conducts classified management of medical devices in the same way as most countries, and has both pre-market approval and post-market surveillance. The 2014 edition of the Medical Device Supervision and Administration Regulations ( State Council Order No. 650) is the highest level of medical device supervision in China Regulation According to the regulations, the state implements classified management of medical devices according to the degree of risk. The first category is low risk, regular management can ensure its safety, effective medical equipment. The second category is moderate risk and needs strict control. Management to ensure its safe and effective medical equipment. The third category is medical equipment that has high risks and needs special measures to strictly control management to ensure its safety and effectiveness. The drug regulatory department is responsible for the development, production and operation of medical devices. The whole process of supervision is used. The first type of medical equipment implements product record management, and the second and third types of medical equipment implement product registration management. Before the medical equipment is listed, all medical equipment must be approved by the drug regulatory authorities at all levels, of which the second The three types of equipment should submit the clinical trial report (except the products listed in the clinical exemption catalogue) when registering for the first time, and establish a quality system and pass the assessment or certification when the product is registered.
Domestic and international medical device supervision mode and supervision department
Although China has established a relatively complete legal system in a relatively short period of time, with the development of China's economic and social development and the continuous growth of the medical device industry, it is strengthening enterprise Responsibility and innovation supervision methods can not fully meet the needs of the development of the situation. From a national perspective, some medical device review and approval exceeds the statutory time limit, and the review and approval involves too many departments and links. The three types of medical devices in the United States and the European Union only About 10%, and the proportion of the three types of medical devices in China is as high as 20%, which leads to a heavy burden of registration and review of the national bureau. There is a cross-replication phenomenon of pre-market access management, which affects management efficiency.
The 2014 edition of the Regulations on the Supervision and Administration of Medical Devices (No. 650 of the State Council) was implemented on June 1, 2014, reflecting the State Council's regulatory system for establishing the most rigorous coverage, deepening the reform of the administrative examination and approval system and promoting the transformation of government functions. The spirit of the new regulations Compared with the old regulations, the new regulations have made major changes in improving classification management, appropriately reducing ex ante permits, increasing corporate responsibility, and strengthening daily supervision. The main features are as follows:
1. Clarify that medical device classification management is classified according to the level of risk;
2. Release the operation of the first type of medical devices, and change the operation of the second type of medical devices to record;
3. The first type of medical equipment is changed to record management, and the second and third categories continue to implement registration and approval management;
4. 'Apply for the product registration certificate after applying for the production license first' to 'Apply for the production license after applying for the product registration certificate', reduce the administrative license before the examination and reduce the cost of the enterprise. The 16 administrative licenses stipulated by the old regulations are reduced. 9 items;
5. Strengthen daily supervision duties, add medical equipment adverse event monitoring system, medical device continuation registration system, medical device recall system, increase penalties by increasing the scope of punishment, increase penalties for violations;
6. For the first time, it is clear that the drug regulatory department and the competent health department shall supervise and manage medical devices according to their respective duties;
7. Clarify the materials and documents that should be submitted when applying for registration and the product registration application department, which stipulates that the materials submitted by the first type of medical devices do not include clinical trial reports.
In order to implement the “Encouraging Reform of the Evaluation and Approval System” issued by the State Council on October 1, 2017 drug medical instruments Innovative Opinions, the State Food and Drug Administration re-launched the revision of the Regulations on the Supervision and Administration of Medical Devices in 2018, and issued a draft of the regulations on June 25, 2018, in comparison with the 2014 version. In contrast, the biggest change in the draft is that in addition to the full implementation of the medical device listing permit holder system, it is also to reform the clinical trial management system. In principle, the second type of medical devices do not require clinical trials. Approved for listing in the past year or so. In addition, the regulatory authorities will also approve the review and approval authority for the second category of medical devices and then carry them out to the national bureau for authorization and review by the national bureau to promote product review and approval. standard Unification, rational allocation of evaluation resources.
In addition to strengthening the supervision of medical devices from the upper-level method, China has also issued special approval procedures for innovative medical devices, medical device priority approval procedures and measures for exempting clinical trial medical device catalogues to improve the efficiency of medical device approval. After the supervision of the operation and use links, the regulatory authorities will continue to strengthen the post-marketing supervision of medical devices in 2018, and formulate a series of regulatory and regulatory documents, including strict investigation of network operations and sales activities, strengthening on-site inspection of medical devices and increasing penalties. And improve the sampling work, etc.. Focusing on the core objective of ensuring the safety and effectiveness of medical devices, the regulatory authorities will speed up the review and approval system for scientific quality improvement, and more closely regulate the life cycle of medical devices.
Regulatory and regulatory documents planned by the regulatory authorities in 2018