Follow-up and Correction of Medical Device Registration Technical Review

After the registration documents are accepted, the NMPA-CMDE will start the first technical review. Generally,  the applicant will encounter the situation of “supplementary”. Then what is the supplementary?

1.Definition of Supplementary

When the registration information can not meet relevant requirement or need additional information during evaluation, reviewers will issue a "Deficiency Letter" to the applicant collectively requesting the information needed at one time.

2.Requirement of Supplementary

Applicant/Registrant should complete the submission of the supplementary information within one year, according to the "Deficiency Letter" strictly.

3.Tips

- Content description, table of contents and details of supplementary content shall be attached to the deficiencies according to the sequence required by the Deficiency Letter.

- The time of preparation for deficiencies will not be included in review timeframe.

With our rich registration experience,CIRS is able to assist the applicant/registrant to follow-up the technical review and complete the supplementary as required.