Legal & Regulatory Basis:
1. Article 57th 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 stipulations of 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 stipulations of the Factory Management Act, or if such manufacture, as approved by the competent central 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 stipulations of the Pharmaceutical Good Manufacturing Practice Regulations; the manufacture may only begin after the competent central 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 competent central health authority, do not need to comply with the Pharmaceutical Good Manufacturing Practice Regulations. The requirements of the preceding paragraph shall apply to foreign manufacturers of imported medicinal products; the central competent health authority shall send personnel overseas to inspect such foreign manufacturers on a periodical basis or as necessary.
2. The Ministry of Health and Welfare announced on June 16, 2017 (Announcement No. 1061101489) that since January 1, 2018, foreign manufacturers newly establishment, relocation, expansion, and resumption of operations shall apply for site inspections of such foreign manufacturing factories when applying for valve replacements (E.3925); and that since January 1, 2019, foreign manufacturing plants of newly establishment, relocation, expansion, and resumption of operations  shall apply for site inspections when applying vascular graft prostheses (N.3450), corneal prostheses (M.3400), and passive tendon prostheses (N.3025). Subsequent inspections subsequent for the foreign manufacturers of imported medical devices, such as four items mentioned above, shall take place concurrently; and the Food and Drug Administration of the Ministry of Health and Welfare will notify the pharmaceutical agency through an official letter on a yearly basis regarding the schedule of site inspections for foreign manufacturers for next year.
 
To apply: Download and complete the application form firstly. And having a communication meeting with the FDA, then prepare the relevant materials to submit to the FDA.
Subsequent inspections: The approval letter is valid for a period of three years. As is required by Article 9th of the Regulations of Medicament Manufacturer Inspection, please submit the application six months prior to expiration of the approval letter. Download the Application Form, then have a communication meeting with the FDA, and prepare the relevant materials to submit to the FDA. As part of subsequent inspection for foreign manufacturers of imported medical devices, such as the heart valve replacements (E.3925) announced by the Ministry of Health and Welfare on June 16, 2017 (Announcement No. 1061101489), the FDA will, at the end of each year, notify pharmaceutical agencies to apply for site inspections in the coming year. Such a pharmaceutical agency shall submit the application for inspection as mentioned in the letter.

Fees: The cost for inspection is NT$600,000, including NT$60,000 for document ation review and NT$540,000 for site inspection. Up to two items are inspected on-site per case. If it is intended to add items for inspection within the same case, an additional NT$35,000 will be collected if it is for the same factory; if it is for a different factory, NT$105,000 will be added. Such addition is limited to a maximum of two items. There will be other fees including inspectors' travel expenses (airfare, lodging, transportation, and visas; such are pre-collected fees which are to be paid according to the amounts invoiced).

Documents to be enclosed:
1. Application Form for GMP Conformity Assessment for  Foreign Manufacturers of Imported Medical Devices (Site Inspection) × 2
2. Relevant documentation for the manufacturer × 1
3. Relevant documentation for the product × 1
4. Photocopy of the former registration approval letter for GMP Conformity Assessment.(required for subsequent inspections)
Precautions:
With regard to on site 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).