Access to the Taiwanese market
Certification according to Taiwanese regulations
Regulatory framework
Under Taiwan’s medical device regulations, manufacturers are required to set up an organization that complies with the Good Manufacturing Practice (GMP) code. Certification to standard ISO 13485 is recognized as equivalent to GMP.
Taiwan’s Department of Health has set up a technical cooperation program (TCP Program) under which foreign certification bodies are recognized for certification of European production sites.
LNE/G-MED was accredited under this programme in November 2004, following a probationary period covering several phases, including participation in seminars, training of auditors and performance of an audit observed by the Taiwanese authorities.
In order for a local distributor to obtain a licence, LNE/G-MED supplies the manufacturer with:
- a cover letter confirming the validity of the last audit report
- the certificate confirming that the quality management system complies with ISO 13485
- the audit report (in English).