Legal & Regulatory Basis: Article 57 of the Pharmaceutical Affairs Act and the Regulations for the Issuance of Medicinal Products and Medical Devices Manufacturing Licenses and Evidentiary Documents for Good Manufacturing Practices
To apply: Have the documentation ready and mail it or deliver it in person to the FDA (Address:  No. 161-2, Kunyang Street, Nangang District, Taipei City 11561).
Fees: NT$1,500/copy (If a money order or a check is issued, make it payable to the Food and Drug Administration, Ministry of Health and Welfare.)
Application Forms: Application Form for Good Manufacturing Practice Certificate (See attachment)
Documents to be enclosed: Photocopy of manufacturing permit(s) for local/imported medical devices (GMP registration approval letter) (only following site inspection by the competent central health authority)
Precautions:
1. Only one copy of the Chinese and the English Certificates, respectively, may be applied for; otherwise, the reasoning must be specified.
2. Provide truthful information in accordance with what is shown in the original registration approval letter, and complete the form in Traditional Chinese and in English.
3. For manufacturers of local medical devices who intend to apply for a Certificate in English, provide the English for the name/address of the applicant and the manufacturing facility, as well as of the approved items.
4. According to the Regulations for the Issuance of Medicinal Products and Medical Devices Manufacturing Licenses and Evidentiary Documents for Good Manufacturing Practices, foreign manufacturers of imported medicinal devices must be inspected by the central competent health authority and fulfill the requirements of the Pharmaceutical Good Manufacturing Practice Regulations before the pharmaceutical company handling importation may apply for this Certificate.
5. Contents shown on this webpage are based on the latest announcements of the Ministry of Health and Welfare and the Administration.