China NMPA’s New Draft Guidelines for ePRS

2021-06-10

In May 2021, NMPA released 11 new draft guidelines regarding the format of electronic medical device registration management (eRPS) system for both medical device, In Vitro Diagnostics reagents, narcotic drugs, psychotropic drugs, and biological products. Manufacturers and the public can submit opinions and feedback on the new draft guidelines to NMPA by the end of June 2021.

Let us know if you have any questions or need help contacting NMPA regarding the new draft guidelines.info@inspirativemed.com

Title	Release Date	Due Date for Public Opinions	Link to Guidelines
1. Format of Electronic Registration Certificate for Medical Devices (Draft)	May 25	June 25	https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjylqx/20210525135316147.html
2. Format of Electronic Registration Certificate for Medical Devices (In Vitro Diagnostic Reagent) (Draft)
3. Format of Electronic Registration Change Document for Medical Device (Draft)
4. Format of Electronic Registration Change Document for Medical Device (In Vitro Diagnostic Reagent) (Draft)
5. Format of Electronic License for Import of Narcotic Drugs (Draft)
6. Format of Electronic License for Export of Narcotic Drugs (Draft)
7. Format of Electronic License for Import of Psychotropic Drugs (Draft)
8. Format of Electronic License for Export of psychotropic Drugs (Draft for comments)
9. Format of Electronic Certificate for Batch Issuance of Biological Products (Draft)
10. Format of Electronic Notice of Non-approval of Biological Products (Draft)
11. Format of Electronic Registration Certificate of Licensed Pharmacist