In order to implement the requirements of the Opinions of the General Office of the Communist Party of China Central Committee and the General Office of the State Council on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovation in Medicinal and Medical Devices (Office Letter [2017] No. 42), and to orderly promote the electronic declaration of medical device registration, the submission requirements for relevant materials are as follows:

1、 In the application materials for imported products, only the supporting documents, conformity statements, instructions, and labels should be submitted with notarized documents issued by the notary public in the applicant’s location.

2、 Considering the electronic directory structure of the medical device registration electronic declaration information system, the page numbers of the declaration materials under any level of title can be compiled separately.

3、 After the electronic application information system for medical device registration is put into use, one copy of the technical requirements in the electronic registration application materials shall be provided.

This notice shall come into effect on August 1, 2019.

This notice is hereby issued.