On May 22, Ropes & Gray and McKinsey & Company co-hosted the 12th Medtech Regulatory Affairs Roundtable online. Around 40 Regulatory Affairs leaders from Chinese and multinational medtech companies gathered to review and discuss the 2025 Medtech Regulatory Affairs survey on:
- Time to approval
- Implementation of key regulatory initiatives, and
- Areas that require the regulator’s attention.
This blog outlines some of the key takeaways from the discussion.
Time to approval
The survey showed that the average time to approval for Class 3 medical devices was 12-14 months and the average time to approval for Class 2 medical devices was reduced from 11 months to 7-8 months. The survey result relating to Class 2 products seemed much shorter than the Center for Medical Device Evaluation (CMDE) statistics, which were averaged between 10-12 months. Although the Roundtable participants were unable to attribute the difference to a single factor, the empirical consensus was that the review and approval process seemed more streamlined.
Implementation of key regulatory initiatives
The trade friction between China and the US will likely accelerate localization of certain imported products. More than 50% of the survey participants indicated that their companies experienced challenges to supply imported products if they won the public hospital tenders and would consider building a supply chain in China for China. The NMPA’s relaxation of regulatory requirements for relocating the manufacturing operations in Circular No. 104 was welcomed by the majority of survey participants.
Products approved through manufacturing relocation to China would be approved under a separate marketing authorization as a locally manufactured device. Even if the imported product and the locally manufactured one are substantially equivalent, hospitals do not acknowledge these two products as interchangeable in the formularies and require resubmission and reevaluation of tenders and listing. This may disrupt the supply chain transition and discount the policy incentives for manufacturing relocation.
A small percentage of companies were able to take advantage of the registration self-test option when applying for marketing authorizations in China. Nevertheless, the majority of survey participants were not particularly enthusiastic in rolling out the registration self-test.
It appears that regulatory authorities may set a higher bar for pre-approval inspections if marketing authorization applicants use registration self-test to show conformity with the specifications and China's mandatory standards. Also, third party testing labs lack consistent qualifications and the CMDE process for receiving and reviewing registration self-test reports was not well-established or well-communicated. These hurdles may have deterred medtech companies from considering registration self-tests.
Areas for the regulator’s attention
Some survey participants identified post-approval change management as an area that require the National Medical Products Administration (NMPA)’s further attention. As a general principle, changes that affect product safety and efficacy must be approved by the NMPA before being introduced.
The NMPA interprets that all changes made to product technical requirements as substantial, but this approach may be overly rigid. For example, the supplier of materials may change the numbering method for the raw materials without changing the manufacturing process or specifications of said materials.
If the material’s model number was included in the approved product technical requirements, it can trigger the need for a change approval. The more post-approval changes require an approval, the more likely that device manufacturers could face a challenge to properly transition the product inventory and plan their manufacturing cycles. Roundtable participants therefore advocated for a regulatory approach that is more attuned to actual risks and specific facts and a 3-6 month grace period that provides a lead time for implementing the approved changes and supply chain management.
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