Beijing, China — In response to a significant rise in medical device registrations, China is advancing its regulations with the introduction of a draft medical device administrative law. This new legislative framework, under review by the National Medical Products Administration (NMPA), aims to tackle the regulatory inconsistencies that have emerged from a fragmented oversight system.
The proposed law, which recently closed its public consultation phase on September 28, encompasses all stages of a medical device’s lifecycle from research and development (R&D) to manufacturing, distribution, and sales. It marks the first instance of China creating a unified statute at a high legal level specifically for medical devices.
Shanghai-based legal expert Charlene Huang, a partner at Global Law Office, noted that current regulations across the medical device sector have been piecemealed, leading to gaps in regulatory compliance and enforcement. Huang highlighted that a core update in the draft law would allow the transfer of registration certificates, simplifying the process for medical devices to reach commercialization and easing the significant investment burden faced by developers.
Transferring registration certificates under the proposed law would catalyze the commercialization of expensive devices, which require extensive investment. Citing the example of Mindray, Huang mentioned that the medical technology company invested approximately USD 397.6 million in R&D within just the first three quarters of this year.
The draft law also emphasizes the importance of maintaining stringent safety and effectiveness criteria for medical devices. Under the new regulations, registration certificates would not be transferable if the devices have been marked as expired, invalid, obsolete, refurbished, or have failed inspections.
Furthermore, the proposed draft stipulates enhanced responsibilities for local legal representatives of imported medical devices. Katherine Wang, a partner based in Singapore with the firm Ropes & Gray, discussed how these agents would be jointly liable with registrants and filers for compliance post-approval. This includes obligations such as annual reporting and coordinating with the NMPA on overseas inspections.
The NMPA is also taking decisive measures to curb malpractices within the expanding market. In the previous year, the administration investigated over 36,000 cases related to medical devices, transferring 216 for judicial intervention. As part of its tightening of regulations, the NMPA has proposed a reward system that could grant up to RMB 1 million to internal whistleblowers who expose significant illegal activities in the sector.
The increasing scrutiny and evolving regulatory framework reflect the medical device industry’s rapid growth in China. In 2023 alone, the NMPA received 3,559 initial registration applications, a 34% increase from the previous year, with total registrations including renewals and changes reaching 12,000.
China’s robust approach to managing its burgeoning medical device sector underscores its commitment to ensuring compliance, safety, and innovation in a field that significantly impacts public health.
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