Report on Efforts by Healthcare Equipment Working Group, CDMD, and COCIR to Address COO Requirements for Registration of Imported Medical Devices in China
2023-07-17 | Beijing, Shanghai
The National Medical Products Administration (NMPA) in China mandates that the country of origin (COO) of an imported medical device be included in the documentation required for registration. Compared to other countries, the inclusion of COO in the documentation required for registration has resulted in slower approval of imported products in China. In response, the industry has been lobbying for years for a more comprehensive understanding of the requirements of countries around the world, especially those in CPTPP (Comprehensive and Progressive Trans-Pacific Partnership Agreement), the EU, the US, and other key countries for medical device marketing.
To address this issue, the Healthcare Equipment Working Group, Consumable and Disposable Medical Device Desk (CDMD), and COCIR coordinated with their branch offices in relevant markets to gather the information that NMPA requested. On 17th July, the joint venture submitted a report to Department of Medical Device Registration and Management of NMPA for their further consideration.
The report aimed to answer two main questions:
- Does a country require the submission of COO to the local authority when registering an imported medical device?
- If COO is required, can it reduce the submission of registration data, such as local clinical trials or performance verification?
The efforts of the Healthcare Equipment Working Group, CDMD, and COCIR demonstrate their commitment to advocating for a more streamlined process for the registration of imported medical devices in China. We hope that the NMPA will take into consideration the findings of this report and work towards a more efficient and effective system for all stakeholders involved in the medical device industry.