On July 1, the CMDE (Centre for Medical Device Evaluation) of NMPA (National Medical Products Administration) released the draft guidance document for the registration of citric acid disinfectant products.
Disinfectant products are Class III medical devices and are exempted from clinical trials. The draft guidance document addresses the following basic dossiers required during the NMPA registration process:
- All of the ingredients, formula, content, pH value, temperature for use, expiry date etc.
- Comparison table will be required to fill in when necessary
- Material used for initial packaging
- Sales performance
- Status of research and development
- Occurrence of any adverse events
- Same type of disinfectant products or predecessor products for comparison
- Environment intended for use
- Conditions for use
- Precautionary statement
Market surveillance of raw materials
- Submit the names, codes and formula of the all the chemical entities used
- Name of supplier
- Conformity standards
The public consultation ends on August 3. Read our recent article about the approval process and revised standards for disinfectants in China.
By Jacky Li. Contact Cisema if you would like to learn more.