1. “Measures for the Management of Clinical Use of Medical Devices”
In January 2021, the National Health Commission issued the “Management Measures for the Clinical Use of Medical Devices”, which will be officially implemented on March 1, 2021. The “Administrative Measures” clarify the responsibilities of medical institutions in the evaluation, purchase, installation and acceptance of medical devices, require medical institutions to establish a medical device acceptance verification system, and require medical institutions to establish a risk management system for clinical use of medical devices.
2. The unique identification of medical devices is officially implemented
In September 2020, the State Food and Drug Administration, the National Health Commission, and the National Medical Insurance Administration jointly issued a document requiring that starting from June 1, 2022, medical devices produced should have unique medical device identification. The first batch of 69 varieties in 9 categories will officially implement unique identification starting from January 1, 2021.
3. “Medical Equipment Industry Development Plan (2021-2025)” (Draft for Comments)
On February 9, in order to accelerate the high-quality development of the medical equipment industry, the Ministry of Industry and Information Technology released the “Medical Equipment Industry Development Plan (2021-2025)” and publicly solicited opinions from the public.
The “Draft for Comments” proposes that by 2025, key components and materials in the field of medical equipment will have achieved major breakthroughs, high-end medical equipment will be safe and reliable, product performance and quality will reach international standards, and the medical equipment industry system will be basically complete. At the same time, specific goals have been put forward in terms of domestic brand development capabilities – by 2025, 6 to 8 companies will enter the top 50 global medical device industry, focusing on the development of seven major areas: diagnostic testing equipment, treatment equipment, monitoring and life support equipment, traditional Chinese medicine diagnosis and treatment equipment, maternal and child health equipment, health care rehabilitation equipment, and implantable interventional equipment. Details below.
4. “The 14th Five-Year Plan and Outline of Long-term Goals for 2035”
On March 11, 2021, the Fourth Session of the 13th National People’s Congress voted and adopted a resolution on the “14th Five-Year Plan” and the outline of long-term goals for 2035.
The “Planning Outline” emphasizes that during the “14th Five-Year Plan” period, we must fight for key core technologies, including the development of key core technologies in cutting-edge fields such as artificial intelligence, quantum information, life and health, and brain science, as well as the prevention and control of emerging infectious diseases and biosafety risks, medicine and medical equipment, key components and parts, and basic materials.
The “Planning Outline” also proposes to cultivate advanced manufacturing clusters, promote the innovative development of the medical equipment industry, break through core technologies such as endoscopic surgical robots and extracorporeal membrane oxygenation machines, and develop large-scale medical equipment and key parts such as high-end imaging and radiotherapy. Develop implantable interventional products such as pacemakers and fully degradable vascular stents, and promote the upgrading of rehabilitation auxiliary devices.
5. The latest “Regulations on the Supervision and Administration of Medical Devices”
On March 18, 2021, the State Food and Drug Administration issued the latest “Regulations on the Supervision and Administration of Medical Devices”, which will be officially implemented on June 1.
The revised “Regulations” mainly include four directions: First, many new systems, new mechanisms, and new methods have been added, the medical device registrant and recorder system has been implemented, the supervision system has been improved, a professional and professional inspector system has been established, and the governance level has been improved;
The second is to simplify and optimize the review and approval procedures, strive to improve regulatory efficiency, and encourage innovative development of the industry. Incorporate medical device innovation into development priorities, optimize approval and filing procedures, implement tacit permission for clinical trials, shorten the review period, and implement informed filing;
The third is to refine and improve the responsibilities for the entire life cycle of medical device quality and safety, stipulating that registrants and filers should establish and effectively operate a quality management system, strengthen post-market management of products, establish and implement product traceability and recall systems, and bear responsibility for the safety and effectiveness of medical devices throughout the entire process of development, production, operation, and use in accordance with the law;
The fourth is to increase punishment and increase the cost of violating the law. Implement the requirement of “punishment reaches the individual”, increase the intensity of penalties for illegal entities by prohibiting them from entering industries and markets, and significantly increase the amount of fines. It has established that the supervision and management of medical devices follows the general principles of risk management, full-process control, scientific supervision, and social co-governance, and has put forward general requirements and pointed out the general direction for the supervision of medical devices in the new era.
6. Medical device registrant system
In May 2021, the State Food and Drug Administration held a summary meeting on the pilot work of the medical device registrant system, requiring all localities to scientifically grasp the rights and obligations between the registrant and the trustee, as well as the legal relationship between cross-regional collaborative regulatory authorities, effectively strengthen the post-market supervision work under the medical device registrant and filer system, and ensure the full implementation of the registrant and filer system.
7. “Guiding Opinions on Carrying out Nationally Organized Centralized Procurement and Use of High-Value Medical Consumables”
On June 4, 2021, eight departments including the National Medical Security Administration, the National Development and Reform Commission, and the National Health Commission jointly issued the “Guiding Opinions on Carrying out Centralized Bulk Procurement and Use of High-Value Medical Consumables for National Organizations” to provide overall specifications and requirements for carrying out centralized bulk procurement of high-value medical consumables for national organizations.
The “Opinions” clearly state that the centralized mass purchase and use of high-value medical consumables organized by the state will focus on products with large clinical usage and high purchase amounts. It also requires strict formulation of quality and technical standards for shortlisted companies, strengthening the main responsibilities of enterprises, and strengthening quality supervision throughout the chain. Consolidate the responsibility of the selected enterprises to meet procurement needs within the procurement cycle and ensure timely supply and delivery.
8. Medical device registration and filing management
The State Administration for Market Regulation reviewed and approved the “Measures for the Registration and Filing Management of Medical Devices” and the “Measures for the Registration and Filing Management of In Vitro Diagnostic Reagents” at the 11th Bureau Executive Meeting in 2021. The two “Measures” will come into effect on October 1, 2021.
The key points of this revision include: first, adding a special chapter on special registration procedures, stipulating innovative product registration procedures and priority registration procedures; stipulating emergency registration procedures, clarifying the scope of inclusion, support policies, etc. of each procedure; second, clarifying extended inspection requirements, improving clinical trial risk control and clinical trial on-site inspection related regulations, and establishing a responsibility interview system. At the same time, we will strengthen the implementation of the main responsibilities of medical device registrants and filers; third, simplify the requirements for overseas listing certification documents, inspection reports and other registration and filing materials. The inspection report requirements for Class II and III medical devices have been adjusted to clarify that registration applicants can submit self-inspection reports; fourth, the relevant requirements for clinical evaluation of medical devices have been adjusted to clarify the circumstances in which submission of clinical evaluation materials is exempted and the requirements for implicit permission for clinical trial approval.
In addition, in 2021, the national and even local levels have also introduced a series of relevant policies that benefit domestically produced devices. Through procurement restrictions and increased approval requirements, the market will be guided to shift to domestic medical devices of the same level to support domestic products to enter and fully participate in market competition. I believe that with the support of national policies, domestic medical devices will usher in a brighter future by insisting on continuous innovation!