Good News for Taiwan Medical Device Enterprises

Oct 30^th 2015, Taiwan Venice Laboratories Co., LTD has recorded their product--Adhesive bandage, a Class I medical device, in Fujian Food and Drug Administration (FJFDA) successfully. This is the first successful case that CFDA entrust FJFDA to dispose the record of medical devices of Class I which come from Taiwan.

Pursuant to relevant regulations, FJFDA is commissioned by CFDA to manage the record of medical device of Class I imported from Taiwan. And Taiwan applicants can choose the proper FDA to record their product depend on their own situation, CFDA or FJFDA. If your product meet below conditions, you can apply for record in FJFDA.

1. The origin of your medical device is from Taiwan and you already had obtained the sale certificate from Taiwan Food and Drug Administration.

2. Your medical device is listed in the Entrusted Catalogue of Class I Medical Device disposed by FJCFDA (see Table. 1below).

3. You shall apply for record through your China agent whose company is registered in Fujian or through your representative office that set up in Fujian.




The record procedure for Taiwan medical devices of Class I is same to the imported Class I medical device. You can catch the procedure by reading our news ---- The Record Procedure for Imported Medical Devices of Class I in China.