When learning about your product’s China NMPA regstration, the following questions are very important to know:
It is a registration process in which the medical devices (including IVDs), drugs, and cosmetics are certified by the China NMPA (National Medical Products Administration, former CFDA) according to guidelines.
The classification of medical device determines documentation required for China NMPA registration. NMPA categorizes medical devices (including IVDs) into three classes (from I to III) based on their risk levels, as Class I being the lowest risk and Class III being the most complex and of highest risk.
Class I: low-risk medical devices whose safety and effectiveness are ensured through routine administration
Class II: Mid-risk medical devices that require further control to ensure their safety and effectiveness
Class III: High-risk medical devices that are implanted into the human body, used to support, or sustain life, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness.
IVD reagents are divided into 22 categories:
Class III reagents include:
1) The testing of pathogenic antigens, antibodies and nucleic acids;
2) Blood type and tissue type;
3) Human genetic testing;
4) Hereditary diseases;
5) Narcotic drugs, psychotropic substances and medical toxic drug testing;
6) Therapeutic targets detection;
7) Tumor marker detection;
8) Allergen testing
Class I include:
1) Microbiological media (not used for microbiological identification and susceptibility testing;
2) Sample processing products, such as hemolytic agents, diluents, and dyeing solution.
All other reagents that are not classified as Class I and III, are in Class II.
The timeframe of China NMPA medical device registration can vary from 12 to 22 months. The time length is dependent on the product, such as the classification, required testing, etc.
The NMPA registration process for medical device to obtain approval can be complex. There are hidden bumps and unforeseen challenges. Firstly, refer to the latest NMPA Medical Device Classification Catalog and determine the class of the medical device. Then, prepare the NMPA registration dossier for unexempted Class II and III devices, prepare the Clinical Evaluation Report in accordance with all regulations. The NMPA approval for medical devices is valid for 5 years. The NMPA registration pathway could vary depending on the product. China NMPA implemented Green Pathway, which accelerates the registration process in China. Three fast-track channels have been established by NMPA to encourage innovation and resolve special medical needs: innovation approval, priority review, and emergency approval. Overseas manufacturers should keep in mind that both domestic and overseas manufacturers share equal opportunity for “Green Pathway”. The innovation approval does not bypass the clinical evaluation process; however, it can be initiated while applying China Patent & Trade Office coverage to shorten the time.
The regulations for the NMPA registration include:
1) GB Standards (Guobiao, Chinese National Standards”) and
2) YY standards (Industry Standards)
Both types of standards share similarities with international standards and are supplemented by Chinese- specific requirements. The previously obtained ISO standards serve as helping tools but are not mandatory. Manufacturers shall obtain complete information and updates on NMPA regulations to ensure their compliance of NMPA registration requirements during the registration process.
Clinical trials are required for all Class II and Class III devices, unless the device is listed for clinical trial exemption. China NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on May 19, 2022, suggesting how to make choices among clinical evaluation exemption, predicate device comparison and clinical trial pathways. For non-exempt devices, the submitted Clinical Evaluation Report (CER) required by NMPA registration shall include the predicate product determination, evaluation path, comparison of device in application and the equivalent device, and analysis of clinical data of predicates. NMPA has issued eight draft guidelines to regulate clinical pathways, from clinical trial, clinical exemption, to evaluation report and same-variety comparison.
