Overview
China is one of the fastest-growing markets for medical devices, where the demand for devices is majorly met through imports. The National Medical Products Administration (NMPA) is the main Regulatory authority in charge of the medical device approval process in China. The NMPA was formerly known as the CFDA. The Centre for Medical Device Evaluation (CMDE) is a body working under the NMPA and is responsible for the review of the medical device import registration applications of all the three (03) classes of devices (Class I, II, & III) in China. The central regulation governing the medical devices approval process in China is State Council Order No. 739.
Device Classification
As per the NMPA regulations, the medical device classification in China is stated in the Medical Device Classification Catalog (Announcement No. 104/2017), * or the rules in Order No. 15 for novel devices.
|
Device Class |
Risk |
|
I |
Low Risk |
|
II |
Medium Risk |
|
III |
High Risk |
Device Registration
According to the medical device approval process in China, a foreign manufacturer without a physical office in the country shall appoint a China Authorized Representative (CAR) for medical device registration in China. The agent is entitled to manage the registration and to communicate with the NMPA before, and after the registration. The certificate issued by the NMPA will appear on the registration certificate. The license, however, is owned by the manufacturer.
Based on the China medical device classification norms, the Class I devices undergo administrative review, whereas Class II and Class III devices undergo the complete China medical device registration process. The data and testing requirements vary based on the availability of predicates. Hence, Class II and Class III device manufacturers should also identify predicates to determine the clinical data requirements for their devices.
Once the manufacturer demonstrates the origin country approval, Freyr China will help you get the NMPA license.
- CER report
- Conduct clinical trial (if applicable)
- Local testing
- Documents filing
- Renewals of licenses
- Compile the dossier and submit it to the NMPA for the approval process
- Payment of administrative and registration fees timely
Freyr Expertise
- Medical Device Regulatory Support in China
- Medical Device Import Licenses Support in China
- Medical Device Classification in China
- Regulatory Due Diligence for Medical Device Registration with the NMPA, China
- Regulatory Intelligence (RI)
- In-country Testing, Including Non-clinical and Clinical Testing
- Clinical Evaluation Report (CER)
- QMS Compliance
- Compilation of Device Documents and GRP documents
- Labeling Services
- Translation Services
- Submission and Liaising Services with the NMPA
- In-country Representative
- Distributor-identification and Qualification
- Onsite Audit
- Pre-preparation/Local Firm Setup
- GSP/GMP/QMS Setup
- UDI
- PMS
