Registration of class II and class III medical devices is central to China’s medical device regulatory system – it determines both product safety and effectiveness and patient protection. This article summarises the regulations, classification and registration process set by the National Medical Products Administration (NMPA).
1. Regulations
- Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 739): the core regulation establishing lifecycle management of medical devices – development, manufacturing, distribution and use.
- Provisions for Medical Device Instructions for Use and Labels (CFDA Order No. 6): content and format requirements for IFUs and labels.
- Measures for the Administration of Medical Device Registration and Filing (SAMR Order No. 47, replacing the former CFDA Order No. 4): procedures, requirements and responsibilities for registration and filing.
- Measures for the Administration of IVD Reagent Registration and Filing (SAMR Order No. 48): specific rules for in vitro diagnostic reagents.
2. Determining the device class
- References: the Medical Device Classification Catalogue (CFDA Announcement No. 104 of 2017) and its partial adjustments (e.g. NMPA Announcement No. 25 of 2022).
- Classification determination: where the class is unclear, companies can 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.
- Supporting documents: e.g. the procedure for dynamic adjustment of the classification catalogue (No. 60 of 2021) and the working rules of the NMPA Medical Device Classification Technical Committee (2023).
3. Drug-device combination products
Combination products consist of a drug and a device produced as a single entity. Their primary mode of action is determined in accordance with the NMPA procedure for determining the attribute of drug-device combination products and the related application requirements (NMPA Notice No. 52 of 2021, Annexes 1 and 2).
4. Registration routes
- Domestic class II devices: the applicant submits the dossier to the medical products administration of its province, autonomous region or municipality.
- Domestic class III devices and imported class II and III devices: the dossier is submitted to the NMPA. Foreign applicants must appoint a legal entity in China as their agent to handle registration; the agent assists the registrant in fulfilling its obligations under the Regulations and in bearing the corresponding legal responsibilities. Imported devices also require evidence that the device is approved for marketing by the competent authority in the applicant’s country (region) of registration or manufacture (unless exempted, e.g. for innovative devices).
- Innovative devices: special review procedures exist at national level and many provinces have supporting policies, for example Shanghai’s innovative device registration guidance service rules (2023) and Jiangxi’s registration procedure for innovative class II devices (2022).
- Priority review: available, for example, for devices that diagnose or treat rare diseases or malignant tumours with clear clinical advantages, devices for diseases specific to or common in the elderly for which no effective means currently exist, and devices included in national science and technology major projects or national key R&D programmes.
5. Registration dossier
- Standard registration (domestic/imported class II and III devices and IVD reagents): regulatory information, summary information, non-clinical data, clinical evaluation data, IFU and label drafts, and quality management system documentation.
- Innovative devices: in addition, the application form for special review of innovative devices, intellectual property documentation and evidence of the product’s innovation.
- Supporting announcements: NMPA Announcement No. 121 of 2021 (dossier requirements and certificate formats for medical devices) and No. 122 of 2021 (for IVD reagents).
6. Responsibilities and obligations of the registrant
- Responsibility: the registrant is responsible for the safety and effectiveness of the device throughout development, manufacturing and use (SAMR Orders No. 47 and 48).
- Obligations: establish and maintain a quality management system appropriate to the product; develop and implement post-market research and risk control plans; carry out adverse event monitoring and re-evaluation; and fulfil other obligations set by the NMPA. These are specified further in the provisions on enterprises’ primary responsibility for medical device quality and safety (No. 124 of 2022).
How EVERBIZ can help
EVERBIZ has extensive experience in quality systems and product registration in China and supports foreign manufacturers through the entire NMPA registration process. Contact us.
This article is for general information only and does not constitute legal advice. Current NMPA regulations are authoritative.