Follow-up Advocacy Letter to the National Medical Products Administration on the Registration and Administration of Blood Screening IVD Products

2019-12-23 | Beijing

On 23rd December, the medical devices sector submitted an advocacy letter to the National Medical Products Administration on the registration and administration of blood screening In Vitro Diagnosis products as the follow-up action of the advocacy letter sent on 19th September.

he letter was addressed to the Commissioner Hong Jiao, the Department of Medical Products Registration and Administration, and the Department of Laws and Regulations.

It is recommended that in the third part of the Regulations on the Registration of Biological Products and the Requirements for Filing of Materials (Trial) in the Annex to the Regulations on the Administration of Drug Registration (Revised Draft) , add the section of new methodology or modify it as new methodology and new IVD reagents, and publish guidelines for registration requirements.