Understanding Taiwan's Two-Stage Process for Medical Device Registration

Registration Process for Medical Devices in Taiwan

The registration of imported medical devices in Taiwan requires a two-stage process. Manufacturers must obtain a Quality System Documentation (QSD) certificate under a Quality Management System (QMS) inspection before they can apply for product registration.

First Stage: QMS Inspection

In the first stage of QMS inspection, manufacturers can apply through standard mode, which requires a full set of quality procedures and related documents. However, several different application modes are available for certain foreign manufacturers to simplify the review process. Notably, manufacturers located in the US, Puerto Rico, or Guam and certified to ISO 13485 standard can utilize the US simplified mode.

Exemptions from Full Quality Documentation

Manufacturers can present an Established Inspection Report (EIR) issued by the US FDA within the last three years, along with a Certificate for Foreigner Government (CFG) issued within the last two years. This can exempt them from providing the full quality manual, quality procedures, factory plant layout, production area layout, and a list of manufacturing and inspection equipment.

For manufacturers without an EIR within three years, audit reports issued under MDSAP can be provided instead.

References

• Taiwan Laws - https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0030112
• FDA Taiwan News - https://www.fda.gov.tw/TC/newsContent.aspx?cid=3&id=27386

Regulatory Impact

Type Approval impacted: Medical
Approval Process impact: N.A.
Importation process impact: N.A.
Type of product impacted: Medical