Service

Product registration/filing

Medical devices, which are/will be marketed and used in the People’s Republic of China, shall be registered/filed with the NMPA/competent local authorities.

Including but not limited to:

Filing/variation of Class I devices;

First time registration of Class II and III devices (domestic);

First time registration of Class II and III devices (imported);

Renewal of Class II and III devices

Variation Class II and III devices (cleared/registered items)

Clinical trial application

Change of Instructions for Use

Re-issuance/correction/cancel of medical device certificates

 Service Contents:

 Document preparation, guidance and review

Supplementary information guidance

Drafting technical requirements

Technical review, evaluation and communication

Product testing service

Registration strategy design

Clinical trial application