Assistance with Taiwan FDA Regulations

Our Service of Registration(Certification) and Specific Industry Surveys of Medical Devices(Medical Device Regulatory Affairs), Cosmetics, and (Functional) Foods in Taiwan.

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Food Drug Administration in Taiwan of ROC (TFDA) is the competent authority of general foods, functional foods, cosmetics, and medical device surveillance, approval and registration(certification) in Taiwan. Taiwan FDA regulates all medical devices (no matter it is classified into Class I, II, or III) to be on the market in Taiwan under Pharmaceutical Affairs Act. Therefore, all items will be regulated through either pre-market registration(certification)/approval, or label/leaflet requirements, or post market surveillance procedures. Taiwan FDA though had relaxed the restrictions on medical devices and supplies for sales via mail/internet order channels (announced under “Registration(certification) for Sales of Medical Equipment via Mail Order Channel and Matters Required for Pharmaceutics” on 2015/06/30), all the items that on the list still will need to be registered with or approved by Taiwan FDA.

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(Medical Device Regulatory Affairs). 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.

Food Drug Administration in Taiwan of Medical Device Products Registration (certification) in Taiwan

According to Taiwan FDA regulation, the medical devices only can be sold after investigation and registration(certification). If the applicant is not familiar with the regulations in Taiwan, or needs technical assistance during the investigation by Taiwan FDA, it is a good idea to hire professional consultants to help. Our services include(Medical Device Regulatory Affairs) :

• Taiwan regulatory support.
• Device classification according to Taiwanese medical device legislation.
• Device registration(certification)
• Guidance on labeling requirements & labeling review.
• Preparation and/or review of technical documentation.