With the introduction of the concept of full‑life‑cycle management for medical devices, China’s regulatory framework for the medical device industry has continued to become more standardized, and evidence‑based regulatory measures are being systematically implemented and refined. According to statistics, since 2016, nearly 300 products have been voluntarily withdrawn during the registration process. “The primary reasons lie in deficiencies or shortcomings in areas such as R&D compliance, risk management, clinical trial integrity, and manufacturing standards,” explained Jiang Haihong, Director of the Medical Device Regulation Program at Shanghai Health Medical College.

　　Recently, the first Summit Forum on Key Points of Medical Device Registration Inspection and Post-Market Supervision was held in Kunming. At the event, Yang Guang, Deputy Director of the Administrative Licensing Division of the Guangdong Provincial Food and Drug Administration— who has long been responsible for medical device product registration—stated: “The inspection of the quality management system for medical device registration is the final hurdle before a product can be approved for market launch; it determines whether a product can obtain registration and enter the market, while also ensuring that the quality management system of marketed products is genuine, safe, and reliably stable. Building a robust quality management system should therefore receive the highest level of attention from medical device enterprises in China.”

　　 Passing the registration review on the first attempt is no easy feat!

　　The core of the medical device registration quality management system verification (hereinafter referred to as “registration verification”) is to assess the applicant’s product samples by examining their development, storage, production, and testing management, as well as departmental responsibilities, thereby extending the review to the enterprise’s overall quality system—its establishment and operation. This enables an evaluation of whether the enterprise’s quality management system can effectively identify and control product risks, ultimately leading to a conclusion regarding the authenticity of the submitted product samples.

　　“In reality, the first‑time pass rate for product registration inspections among medical device companies is virtually zero—even a company like Shenzhen Mindray has not achieved a perfect score on its first attempt,” Yang Guang remarked with a sigh.

　　According to reports, in 2016 the Guangdong Provincial Bureau completed registration inspections for more than 700 Class II medical device products. Combined with the 170 domestic Class III device registration inspections conducted on behalf of the National Medical Products Administration, a total of over 870 product‑上市 registration inspections were carried out. Among these, 10% were rejected outright on the first review, while the remaining cases generally required “re‑inspection after corrective actions” before passing.

　　Lin Feng, Director of the Medical Device Registration Division at the Shanghai Municipal Administration for Market Regulation’s Food and Drug Administration, also stated that most medical device registration inspections in Shanghai require a “re‑inspection after corrective actions.” Only after the re‑inspection confirms compliance with the requirements of the Medical Device Production Quality Management Regulations and their relevant annexes may registration be granted. In the very rare cases where an inspection is not passed, the technical review authority issues a negative review opinion recommending non‑registration. Since product registration cannot be approved on the first attempt, enterprises required to undergo re‑inspection following corrective measures must submit both a re‑inspection application and a corrective action report to the original inspection authority within six months. This practice not only wastes regulatory resources but also delays the product’s market launch.

　　 “Key item” is key.

　　“Following the implementation of the 2014 amendment to the Regulations on the Supervision and Administration of Medical Devices, the former assessment of device quality management systems was replaced by a registration‑based quality management system inspection, which now imposes even higher requirements,” explained Yang Guang. He added that, as the registration inspection represents the final checkpoint in the pre‑market quality management system review for medical devices and carries the critical responsibility of verifying the authenticity of submitted information on-site, it wields a decisive veto power over whether a medical device can successfully obtain registration and be placed on the market.

　　“Even if all other registration documents and inspections are completed to the highest standard, it will still be futile,” Yang Guang emphasized. Once a single item is rejected, the company must resubmit its registration application, wasting valuable time and registration fees—particularly in terms of market launch timing, as the entire process must start from scratch and re-enter the queue.

　　The “Good Manufacturing Practice for Medical Devices” and its four associated annexes each comprise more than 200 provisions. Among these, a large number of critical items are marked with an asterisk; if even one such item fails to meet the requirements, the inspection is deemed “failed.” For non‑critical items, up to three to five deviations are permissible, but the review outcome will be “reinspection after corrective actions.” “This places considerable pressure on enterprises,” said Yang Guang.

　　According to Qiu Wanyu, Deputy General Manager and Management Representative of Beijing Fule Technology, the company undergoes two new‑product registration inspections on average each year. “Under the ‘Guiding Principles for On‑Site Inspections of Implantable Medical Devices’ within the Medical Device Production Quality Management Regulations, nearly 300 requirements apply to orthopedic materials, 46 of which are classified as critical—each one must be addressed with utmost care. If even a single item fails to meet the standards, the entire registration application will be rendered futile,” he explained. He added that any minor issue identified in the quality management system, even if it is not deemed critical, must be rectified in accordance with the prescribed requirements; only after passing a follow‑up inspection may registration be approved, which inevitably delays the product’s market launch.

　　Based on Guangdong Province’s experience in recent years with the review and verification of medical device product registrations, it has become evident that most enterprises tend to encounter issues in the following areas: First, there are discrepancies in the interpretation of regulatory requirements—for example, insufficient attention is paid to production address information and the acceptance of environmental monitoring reports, and technical requirements fail to distinguish between factory‑outgoing testing and type‑testing. Second, deficiencies are found in the submission documents, such as unclear descriptions of the product’s development and manufacturing locations, incomplete design and development stages, lack of appropriate production conditions, or significant hardware defects. Third, non‑compliant findings are identified during on-site inspections, including quality management systems that do not adequately support product risk management, inadequate controls over design and development, and a lack of substantive R&D activities.

　　Quality management must focus on “systematization.”

　　Yang Guang stated: “To meet the stringent requirements of regulatory oversight, medical device companies must extend their management chains. Particularly for small and medium-sized enterprises, if they are overwhelmed by increasingly demanding technical and operational barriers, they may fail to fully appreciate the importance of a robust quality management system and become lax in its administration. Any shortcomings in the system can give rise to latent quality risks, which companies must address with due diligence.”

　　“If the issues involve hardware—such as corrective actions—the remediation process can be time‑consuming; if critical project deficiencies are identified, the registration inspection will inevitably fail. By contrast, when the problems pertain to softer aspects like documentation preparation or on‑site procedures, correction is relatively straightforward. Therefore, the most effective long-term solution lies in establishing sound, science‑based management principles, cultivating highly qualified full‑time management representatives, and building a robust quality‑management system,” said Yang Guang.

　　On November 14, the Beijing Municipal Administration for Market Regulation—Food and Drug Safety issued the “Administrative Measures for the Management of Managerial Representatives in Medical Device Manufacturing Enterprises in Beijing (Trial),” requiring all medical device manufacturers in Beijing to implement a managerial representative system effective January 1, 2018. The measures clearly define a managerial representative as a management-level employee who possesses relevant professional qualifications or technical credentials, along with appropriate work experience, and who, upon authorization by the enterprise’s principal, assumes full responsibility for ensuring the effective operation of the quality management system. Prior to this, Guangdong and Shanghai had respectively promulgated administrative measures governing managerial representatives in medical device manufacturing enterprises in 2010 and 2015.

　　“Many start-ups focus solely on production technology while neglecting the establishment of a quality management system, lacking dedicated quality‑management personnel and leaving their management systems riddled with gaps,” says Li Yong, the management representative of Shanghai MicroPort Medical (Group) Co., Ltd. He believes that it is essential for medical device manufacturers to appoint full‑time management representatives—tasks should be entrusted to professionals who can handle them effectively. These representatives can ensure proper documentation of system‑supporting files and participate in the comprehensive lifecycle management of products, spanning research and development, clinical trials, manufacturing, and extending through post‑market adverse‑event monitoring, follow‑up tracking, and product recalls.

　　Yang Guang cautioned that representatives of medical device manufacturers should strengthen their study and understanding of relevant laws and regulatory documents. Meanwhile, regulatory authorities should enhance communication and collaboration between inspection personnel and enterprises, fostering mutual improvement to boost inspection efficiency and accelerate the approval and market access of medical devices.