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
