Legal & Regulatory Basis: Article 57 of the Pharmaceutical Affairs Act stipulates that the manufacture of medicaments (medicinal products and medical devices) shall be done by medicament manufacturing factories. Any medicament manufacturing factory shall be established pursuant to the Standards for Medicament Factory Establishments, and shall carry out factory registration pursuant to the Factory Management Act, except when exemption from factory registration is allowed pursuant to the Factory Management Act, or if such manufacture, as approved by the central competent health authority, is for research and development purposes. For purposes of medicament manufacture, the factory facilities, equipment, organization and personnel, production, quality control, storage, logistics, handling of customer complaints, and other matters requiring compliance shall comply with the Pharmaceutical Good Manufacturing Practice Regulations; the manufacture may only begin after the central competent health authority has completed its inspection and granted approval and the medicament manufacture license has been obtained.  These restrictions do not apply to manufacturers of medical devices that, per public  announcement by the central competent health authority, do not need to comply with the Pharmaceutical Good Manufacturing Practice Regulations.

 
To apply: Download and complete the application form; with related materials to submit to the FDA.
Subsequent inspections: The approval letter is valid for a period of three years;. As is required by Article 9 of the Regulations of Medicament Manufacturer Inspection, please submit the application six months prior to expiration of the approval letter. Download the Application Form and related materials for submission as well.

Fee: NT$38,000

Documents to be enclosed：
1. Application Form for GMP Conformity Assessment for Foreign Manufacturers of Imported Medical Devices (Quality System Documentation Review) × 2
2. Quality System Documentation × 1
3. Photocopy of the Certificate of compliance equivalent to medical device GMP certification( Ex:ISO13485) × 1
4. Photocopy of the former approval letter for GMP Conformity Assessment (required for subsequent inspections)
Precautions:
1. For items with which applying for GMP Conformity Assessment is not required, please refer to Attachment 2 of the Regulations for Governing the Management of Medical Device. [Since March 11, 2014, for Class 1 medical devices that are listed as non-sterile or without a  measuring function under  Attachment 2 of the Regulations for Governing the Management of Medical Devices, their manufacturers shall comply with the requirements in Chapter 3 Essential Mode of Part 3 in the Pharmaceutical Good Manufacturing Practice Regulations.]
2. For inspections of medicament manufacturers, please refer to the Regulations of Medicament Manufacturer Inspection.
3. The English version of 3.1-3.10 in the Application Form for GMP Conformity Assessment by Foreign Manufacturers of Imported Medical Devices (Quality System Documentation Review) is for foreign manufacturers’ reference only when preparing the documentation; when submitting, please treat the Chinese application form as authoritative.
4. About the Post-marketing Procedural Review Principles Application Form for GMP Compliance by Foreign Manufacturers of Imported Medical Devices (Quality System Documentation Review), please refer to the attached file below.
5. With regard to onsite inspections for foreign manufacturers of imported medical devices, please refer to the information provided in the Application Guideline for GMP Conformity Assessment for Foreign Manufacturers of Imported Medical Devices (Site Inspection).