On August 28, 2024, the NMPA released the “Law of the People’s Republic of China on the Administration of Medical Devices (Draft for Public Comment).” Feedback needs to be submitted by September 28, 2024.
For the first time that China NMPA regulation for medical devices has been elevated to law level from regulation since Decree 739, the “Regulations on the Supervision and Administration of Medical Devices.” This shows China intends to increase its medical device development and the quality level.
The major proposed changes are outlined below:
Premium Pricing for Innovative Medical Devices
Article 6 introduces legal recognition for the ability to charge a premium for innovative medical devices, allowing them to be priced higher than similar devices. The article emphasizes the need to improve policies related to procurement, medical charges, and health insurance, specifically to support the clinical promotion and use of innovative medical devices. Healthcare institutions are encouraged to prioritize the procurement and use of these devices.
Reducing Standards to Ease the Burden on Manufacturers
Without referring to industry standards, as previously stipulated in Decree 739, Article 21 proposes that “Medical devices must comply with mandatory national standards. In the absence of mandatory national standards, the adoption of recommended national standards is encouraged.” This reduction in the number of standards is intended to lessen the regulatory burden on manufacturers.
Simplifying Clinical Trial Approvals and Establishing Ethical Review Mutual Recognition
Currently, each new clinical trial center in China requires separate ethics approval. For multi-center trials involving more than ten sites, the ethics approval process alone can take 6 to 12 months, often resulting in the lead unit completing enrollment while other centers are still awaiting approval. Article 43 seeks to address this by allowing other participating institutions in a multi-center clinical trial to use a simplified procedure to confirm the lead institution’s ethics review opinion. Local governments are encouraged to strengthen regional ethics review capabilities and promote mutual recognition of these results.
Opening Up to International Multi-Center Clinical Trials
Article 43 also encourages the conduct of international multi-center clinical trials for medical devices. It stipulates that foreign clinical trials should be conducted in countries or regions with established clinical trial quality management systems and must comply with China’s regulatory requirements for medical device clinical trials. If the foreign trial data is scientifically sound, complete, and sufficient, and meets China’s registration requirements, it can be used for medical device registration applications in China.
Eliminating the Requirement for Country of Origin Documentation for Imported Devices
Without mentioning the requirement for a Country of Origin document, as stipulated in Decree 739, Article 47 proposes that “Overseas applicants seeking to export Class II or Class III medical devices to China must designate a domestic legal entity, which holds a medical device production or operation license, as the responsible party within China. This designated entity will submit the registration application materials to the NMPA.”
Extending the Registration Renewal Time Window
Article 56 proposes that “The validity period of the medical device registration certificate is 5 years. If a renewal is needed, an application should be submitted to the original registration department within 6 to 12 months before the expiration of the certificate.” This extends the current time window, which is 6 months.
Introducing the Concept of Domestic Responsible Person for Imported Medical Devices
Article 88 introduces the concept of a domestic responsible person for imported medical devices and outlines their responsibilities. These include conducting post-market risk control, monitoring and reporting adverse events, organizing recalls, assisting in post-market studies, maintaining quality management systems, cooperating with regulatory inspections, and acting as a liaison between the registrant and regulatory authorities.
China Med Device, LLC with its entity in China can be your China local legal agent/representative (domestic responsible person). Our principal, Grace Fu Palma, was involved with the initial task force that discussed and helped establish this law several years ago.
If you would like to schedule a consultation regarding these transformational changes from the NMPA, please email info@ChinaMedDevice.com.
