People’s growing demand for health in recent years has driven expectations for the high-quality development of medical devices to continue to rise. People expect continuous innovation and breakthroughs in medical devices and also focus on the guarantee and improvement of medical device quality safety. Important documents, such as the Opinions on Reform of the Review and Approval Systems for Drugs and Medical Devices of the State Council (GF (2015) No. 44) and the Opinions on Deepening the Reform of the Review and Approval Systems and Encouraging Innovation on Drugs and Medical Devices (TZ [2017] No. 42) of the General Office of the CPC Central Committee and the General Office of the State Council, issued since 2015 have explicitly required thoroughly advancing reform of medical device review and approval and strengthening medical device lifecycle management and implementing enterprises’ entity responsibilities while encouraging innovation. The newly revised Regulation on the Supervision and Administration of Medical Devices (hereinafter referred to as the Regulation) came into force on June 1, 2021 to consolidate the reform results and improve the regulatory system in the form of regulations.

The revised Measures for Supervision and Administration of Medical Device Production (“Production Measures Document”) and Measures for Supervision and Administration of Medical Device Operation (“Operation Measures Document”) issued by the State Administration for Market Regulation of China on March 22, 2022 will come into force on May 1, 2022. Both documents strictly implement the Regulation, fully implement the system of medical device registrants and filing entities, implement enterprises’ entity responsibilities, optimize the administrative licensing process, strengthen the supervision and inspection measures, improve the supervision and inspection means, and further increase punishment for illegal acts.

I. Strict implementation of enterprises’ entity responsibilities favoring the steady development of the industry

The new Production Measures Document strengthens the connection with and implementation of the medical device registrant system, defines the responsibilities of registrants and entrusted manufacturers, includes requirements for management of entrusted production in the quality management system, permits entrusted manufacturers to apply for production licenses upon registrants’ registration certificates, stipulates that registrants are responsible for medical device quality safety and entrusted manufacturers are responsible for their production behavior, requires the two sides to sign agreements on quality of entrusted production, and defines that entrusted manufacturers are responsible for production release and registrants are responsible for marketing release. The new Production Measures Document standardizes, at the regulation level, registrants’ responsibilities and obligations in the production link. For the industry, the new Production Measures Document is beneficial to the effective allocation of resources, promotes production mode upgrading and product responsibility implementation, and raises clear requirements for the industry.

The new Operation Measures Document adheres to the principle of enterprises’ entity responsibilities and requires medical device operating enterprises to establish quality management systems and quality control measures that cover the entire quality management process according to laws and regulations and the requirements of the Good Supply Practice for Medical Devices, keep related records, and ensure their operating conditions and business activities continue to meet the requirements. The new Operation Measures Document strengthens registrants’ responsibility for sales and quality safety, stipulates that registrants can sell their medical devices or entrust medical device operating enterprises to do so, requires registrants, who entrust sales, to entrust eligible medical device operating enterprises and sign entrustment agreements, and defines the rights and obligations of the two sides. The new Operation Measures Document defines the responsibilities of registrants and operating enterprises, which is good for the benign development of the industry.

II. Optimization of the administrative licensing process favoring the efficient development of the industry

The new Production Measures Document stipulates that the time limit for reviewing medical device production license applications is adjusted from 30 working days to 20 working days, and medical device filing entities that produce Class I medical devices can process production filing at the time of processing product filing. With the new Production Measures Document, regulators actively increase their burden to largely shorten the affairs handling period and simplify the affairs handling process, which is beneficial to manufacturers’ shortening of the time required to get approval and acceleration of launch of products to the market.

The new Operation Measures Document permits those who apply for operation licenses for Class III medical devices and process filing procedures for the operation of Class II medical devices at the same time to submit data at a time, with on-site checking completed together, and stipulates that those who have obtained operation licenses for Class III medical devices can be exempted from submitting corresponding data at the time of processing the filing of Class II medical devices. The new Operation Measures Document shortens the handling time limit by adjusting the original 30 working days for reviewing the application data to 20 working days from the dates of acceptance for making decisions. According to the new Operation Measures Document, a list of products exempted from operation filing can be established. Information on 13 products that enter the said list has already been released. Like the new Production Measures Document, the new Operation Measures Document shows regulators’ taking of responsibility and tapping of their potential to largely shorten the administrative approval time, simplify the process, greatly facilitate the enterprises, and promote the efficient development of the industry.

The new Production Measures Document establishes a medical device reporting system and stipulates four forms of reporting, including annual reporting, reporting of product varieties, reporting of changes in production conditions, and reporting of re-production, to standardize reporting of production status by registrants, filing entities, and entrusted manufacturers to regulators. The new Production Measures Document defines the key inspection content for registrants and filing entities, who conduct production themselves or entrust the production, as well as for entrusted manufacturers, refines and defines the systems for information disclosure and regulatory talks with responsible persons, and highlights information technology development for regulation over medical device production and overall advancement of the sharing of information on supervision and administration of medical device production. By consolidating the reform results, the new Production Measures Document improves the regulatory system, enriches the regulatory means, and positively guides and urges the industry to become more standardized.

The new Operation Measures Document stipulates that category and level management shall be implemented and dynamic adjustments shall be conducted according to the quality management of and the risk levels of medical device products operated by medical device operating enterprises, law enforcement inspections shall be conducted according to the annual inspection plans with the inspection focus, frequency and coverage identified, and extended inspections, risk-related consultation and assessment, and credit file systems shall be implemented. The new Operation Measures Document requires further expanding the implementation of the Unique Device Identification system and strengthening regulation over third-party logistics. The new Operation Measures Document strengthens the regulatory measures, enriches the regulatory means, expands the implementation of policies proven to be mature through pilot work, and scientifically strengthens regulation over new business models arising from industrial development, which is beneficial to the industry’s accelerated development towards the right direction.

Comprehensively revised based on the previous editions, the Production Measures Document and the Operation Measures Document strictly implement the “Four Strictest (strictest standards, regulation, punishment and accountability)” requirements and the Regulation. The comprehensive implementation of the system of medical device registrants and filing entities and the quality and efficiency improvement of administrative approval will promote the high-quality development of the medical device industry. Entities in the medical device industry, while enjoying the policy benefits, should perform their responsibilities, strictly abide by regulations and bottom lines, and contribute to the stable and healthy development of the medical device industry.