Taiwan FDA Medical Device

Overview ：Medical devices can be divided into non-in-vitro diagnostic devices and in-vitro diagnostic devices (IVDs). In addition, they may also be divided into Class I and Class II/III according to their risk level. The product need to be registration, the foreign manufacture need to prove they are in conformity with the GMP.

Business Challenges ：What if your product is for health promoting or aesthetic medicine only? Do I need a registration with TFDA? Whether the requirement from the customer is reasonable or not?

Our service ：
(1) Imported Medical Device Classification/Predicate Device Comparison-TFDA
(2) QSD Conformity Assessment
(3) Predicate Device Comparison-TFDA
(4) Design or/and Monitoring of Clinical trial
(5) Product registration

How to start ：Please send us the picture of the product.

Why SCG ：Staff of SCG , who had been trained and certificated by Taiwan FDA, has the expertise and the experience to help companies to list their medical device products and to comply with the regulations. We are also familiar with Functional Foods, Tablets & Capsules, Cosmetics and Advertising Regulations as couple of our staff are qualified official professionals, certificated by The Examination Yuan of ROC as Legal Qualification of Food Professionals.