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Application for QSD Conformity Assessment for Foreign Manufacturers of Imported Medical Devices

【Update Date：2024-08-09】unit：品質監督管理組

 
Introduction:
According to paragraph 1, Article 22 of the "Medical Devices Act", the medical device manufacturers shall establish a medical device quality management system for medical devices, regulating premises, facilities, organization and personnel, production, quality control, storage, logistics, customer complaints, and other matters and shall comply with the "Medical Device Quality Management System Regulations".
Medical device manufacturers shall establish a medical device quality management system in accordance with the provisions of the regulations set forth in the preceding paragraph, and the manufacture may only begin after receiving a compliance inspection by the central competent authority and obtaining a manufacturing license. However, product items that are exempt from obtaining a manufacturing license would be announced by the central competent authority.
In addition, according to Article 78 of the "Medical Device Quality Management System Regulations", the manufacturers engaged in producing only the items as listed in Annex (applicable for essential application mode), shall establish medical device file according to each type or device or series of devices. Each manufacturer shall also implement procedures for control of records, complaint handling as well as corrective and preventive actions.
The manufacturer mentioned in the preceding paragraph, may not be subject to other provisions of this part of these Regulations, except for the provisions of Article 11, Article 12, Article 13, Article 47, Article 55, Article 63, Article 64, Article 69, Article 76 and Article 77.
 
How to apply:
Create a user account on the "Medical Device Quality Management System application platform" and submit the application online.
 
How to renew the 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 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.
 
Who should apply a change:
According to Article 5 of the "Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing license", changing the name, address of the medical device manufacturer and the medical device importer of imported device, shall submit the application by sending the application form to TFDA within thirty (30) days after the actual happening of the occurrence, in one copy of application form, with fee payment(NT$10,000) and the requested documents and materials as set out in Appendix 2.
 
Fee:
(1) Application for QSD Conformity Assessment for Foreign Manufacturers of Imported Medical Devices: NT$60,000
(2) Application for QSD Conformity Assessment for Foreign Manufacturers of Imported Medical Devices (Essential application mode, limited to the items listed in the Appendix of Article 78 of the "Medical Device Quality Management System Regulations"): NT$30,000
 
Notes:
1. In accordance with Article 2 of the "Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing license" related materials as set out in Appendix 1 for submission as well. Medical device manufacturer falling with the scope of an agreement established between other competent authorities with Taiwan (R.O.C), the requested documents could be substituted by other documents known as the abbreviated mode announced by the central competent authority.
2. The audit report required for Japanese abbreviated mode can be either a QMS audit report, or an MDSAP audit report issued by an MDSAP Auditing organization, which is an affiliated member within the same corporate group as the recognized certification bodies (RCBs).
3. The required documents must be in original language, and also need to provide English or traditional Chinese translation.
4. "Application Form for QSD" is only for reference, and all application process must be completed online.