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Application for On-site Inspection for Foreign Manufacturer of Imported Medical Devices

【Update Date：2023-06-08】unit：品質監督管理組

 
Introduction: 
2. Foreign manufacturers applying for items such as replacement heart valves (E.3925), vascular graft prosthesis (E.3450), corneal prosthesis (M.3400), passive tendon prosthesis (N.3025) and implantable Pacemaker pulse generator (E.3610), shall apply for on-site inspection.
3. As for annual follow-up review, TFDA will make a list of medical device manufacturers about who should apply for the on-site inspection for next year, based on the risks of the medical device and the amount of usage.
The following factors will be considered as product risk: no similar device on the market, complex medical device, a large number of intended users with high impact levels, post-marketing adverse events and reports, and QSD cases with concerns.
TFDA will notify the medical device manufacturers through an official letter regarding the schedule of on-site inspections for foreign manufacturers for next year.
 
How to apply:
Fill out the application form and provide related materials for submitting the application. For new applications, medical device manufacturers should notify TFDA prior to submitting the application.
 
How to renew the foreign manufacturing license:
According to Article 6 of the "Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing license", the validity of the foreign manufacturing license would be effective for a period of 3 years. For application renewal, if necessary, shall be made between 6 and 12 months prior to expiration, and each extension period is limited to 3 years.
 
Fee:
The fee of the on-site inspection is NT$600,000, including document review (NT$60,000) and on-site inspection (NT$540,000). Each application for on-site inspection shall be limited to 2 items. For those who intend to apply for more than 2 items, an additional NT$35,000 will be charged for each additional inspection item in the same factory, and an additional NT$105,000 will be charged for each additional inspection item in a different factory. As set forth, shall be limited to 4 items, and those who intend to apply for more than 4 items shall apply for another on-site inspection. For each additional subcontracting factory, an additional NT$300,000 will be charged. Other fees are NT$240,000, 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 need to provide:
1. Application of Conformity Assessment for Foreign Manufacturers of Imported Medical Devices (On-site Inspection) × 2.
2. Relevant documentation for overseas on-site inspection of the manufacturer × 2 (refer to Appendix 1 of the “Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing licens”).
3. Photocopy of the former approval letter for QMS Conformity Assessment (For renew application only).