The registration of imported medical devices in Taiwan requires a 2-stage process. The manufacturers have to obtain Quality System Documentation (QSD) certificate under Quality Management System (QMS) inspection before they could further apply for the product registration of medical devices.
Regarding the 1st stage, QMS inspection, aside from applying through standard mode, for which the full set of quality procedures and related documents have to be provided, several different application modes can be utilized for certain foreign manufacturers to simplify the review process. Specifically, for manufacturers located in the US, Puerto Rico, or Guam and certified to ISO 13485 standard, US-simplified mode can be applied.
Establishment Inspection Report (EIR) issued by USFDA within 3 years along with a Certificate to Foreign Government (CFG) issued within 2 years could be provided to omit the full set of quality manual and quality procedures, factory plant layout, production area layout, and list of manufacturing and inspection equipment. In addition, considering the establishment inspection timeline, for manufacturers without EIR within 3 years, audit reports issued under MDSAP could be provided instead.
TFDA Announcement: Updates of QMS Application Required Documents for Manufacturers in the US, Puerto Rico, or Guam
Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing license