China NMPA
Medical devices need to obtain a NMPA registration license in order to be legally imported and sold in the Chinese market.
Affiliated with National Medical Products Administration (NMPA), the Center for Medical Device Evaluation (CMDE) is responsible for the application and evaluation of medical products classification under Category I, II, and III, especially for overseas manufacturers.
There are three categories per NMPA regulation, and each category is associated with different registration procedures and submission requirements.
Preliminary analysis:
Before starting the application process with the NMPA, it is critical to understand and confirm the applicable product category based on NMPA regulations. VSCB experts can guide you through the identification process (preliminary analysis) under the correct category procedure so you are well prepared for the next steps.
Mandatory Category | Registration Type | Public Administration |
Category I (Low risk equipment) | Registration Record | Municipal level |
Category II (Medium risk equipment) | NMPA Registration | Provincial level |
Category III (High risk equipment) | NMPA Registration | National level |
* The lead time for the preliminary analysis is typically 3-4 weeks
Product information and documents required for preliminary analysis:
1. Product Marketing Approval from original country/region. |
2. Product or system picture with label. |
3. Product description with functional composition, principle, and intended use. |
4. Clinical Report or report to be used as the comparison report corresponding to the same category. |
5. Document for NMPA registration. |
NMPA local testing:
Effective 1st Apr 2017, all the testing fees were waived by NMPA. This change to the once expensive testing procedure has attracted more manufacturers to apply for certification; hence there is a long waiting list given the very few available labs (government-owned, designated by NMPA only).
To relieve the tension of lacking effective testing resources, some of the private labs with good quality and high reputation in the industry were authorized by NMPA to perform the testing, and the test report can be used directly for formal submission.
VSCB has formed a strategic partnership with an authorized private testing lab in Beijing. Owing to our mutual expertise in regulations and understanding of the operations of NMPA, we have been successfully helping our customers obtain market access for their products.
We are able to support you with the following:
• NMPA Preliminary Analysis
• Classification confirmation
• GB/YY standard draft
• Pre-testing per GB/YY testing standard
• Pre-testing standard and result accepted for NMPA/CFDA registration
• Product specifications and operation manual review
• Tests for biology if applicable
• Tests for sterilization if applicable
• On-site witness testing on behalf of government lab
• Solutions for testing failures