China’s National Medical Products Administration (NMPA) plays a central role in medical device regulation. Class I medical devices follow a defined filing procedure, explained below.
1. Regulations
- Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 739): the core regulation providing the framework for the manufacture, distribution and use of medical devices to ensure their safety and effectiveness.
- Provisions for Medical Device Instructions for Use and Labels (CFDA Order No. 6): content and format requirements for IFUs and labels to ensure accurate information for users.
- Measures for the Administration of Medical Device Registration and Filing (SAMR Order No. 47, which replaced the former CFDA Order No. 4): procedures for application, acceptance, review, approval and filing.
2. Confirming class I status
- Classification references: the Medical Device Classification Catalogue (CFDA Announcement No. 104 of 2017) and its partial adjustments (e.g. NMPA Announcement No. 25 of 2022) define the classification of devices and are the key basis for deciding whether a product is class I.
- Classification determination: where the class is unclear, apply through the medical device classification information system on the website of the National Institutes for Food and Drug Control (NIFDC) by completing the classification registration form and supporting documents.
3. Filing instead of registration
- Domestic class I devices: the filer submits the filing documents to the medical products administration of the municipality (city divided into districts) where it is located.
- Imported class I devices: the filing is submitted to the NMPA. The foreign filer must appoint a legal entity in China as its agent, and must provide evidence that the device is approved for marketing by the competent authority in its country (region) of registration or manufacture.
- Devices from Hong Kong, Macao and Taiwan: handled in the same way as imported devices.
4. How the filing procedure works
- Filing on submission: the filing is completed once the filer has submitted complete documents that meet the requirements – there is no technical review or approval as for class II and III devices.
- Transparency: the filing information is published within five working days of completion so that it can be checked by the public.
- Change filing: if any information in the filing changes, a change filing must be made promptly.
- Post-filing responsibility: the filer remains responsible for the product’s safety and effectiveness, must manufacture under a quality management system in line with Chinese GMP requirements, and is subject to supervision and inspection by the authorities.
Part 2 of this series explains the documents required for the first filing of a class I device.
How EVERBIZ can help
EVERBIZ has extensive experience in quality systems and product registration in China and supports foreign manufacturers with class I filings, classification questions and agent services. Contact us.
This article is for general information only and does not constitute legal advice. Current NMPA requirements are authoritative.