Regulations for the Assessment and Approval Process of Hazardous Medical Device

Article 1
The Guideline is stipulated pursuant to Paragraph 3, Article 93 of the Medical Care Act (hereinafter referred to as the Act).
Article 2
The so-called medical device which may cause hazard (hereinafter referred to as hazardous medical device) in the Act means that its use shall be strictly regulated, for any misuse may cause material harm to human health or environmental safety.
Article 3
Hazardous medical device shall be kept and employed by designated physicians in charge; operators shall undertake specialized training.
Article 4
Information and criteria for the types of hazardous medical device, physicians in charge, medical institution which may install such device (hereinafter referred to as the installed institution) are shown in the Appendix.
The applicable symptoms of hazardous medical device, qualification and condition for operators, and other issues shall comply with the Regulation Governing the Application of Specific Medical Examination Technique and Medical Device.
  • Appendix for Article 4.pdf
Article 5
In order to install hazardous medical device, the installed institution shall apply to the central authority with an application form and documents below; the institution may install such device after the review and approval.
1. The registration license of the medical institution and a copy of the supporting documents set forth in the Appendix;
2. A copy of the physician- in- charge qualification;
3. The diagram and manual of the device;
4. A copy of the medical device’s import or manufacture permit.
If for special reasons, the permit specified in Subparagraph 4 shall be applied together along with the building expanding project and cannot be acquired in advance, the central authority may agree to replace it with the import documents.
The central authority may request the installed institution to submit a report on the hazardous medical device approved in Paragraph 1.
Article 6
The central authority may invite experts or authorize professional groups to review the application of hazardous medical device.
The central authority may announce restrictions on the number of hazardous medical device installed in a single medical region or sub-medical region.
Article 6-1
The installed institution obtaining a Hazardous Medical Device Installation Permit shall complete the activation within five years from the date of issuance of the permit.
If the installed institution, under any of the following circumstances, is unable to complete activation within the five-year period specified in the preceding paragraph, it may before the expiration, provide reasons and submit progress reports, the estimated completion period, and other relevant supporting documents and data to the central authority for an extension request. The extension period may be up to three years at most and limited to once.
1.In accordance with the provisions of relevant regulations, the processing timeline is affected by the relevant regulating departments when handling matters such as changing the land use of the hospital base, conducting environmental impact assessments, soil and water conservation measures, medical equipment inspection and registration, or other reasons.
2.Occurrence of disasters as defined in Article 2, Paragraph 1 of the Disaster Prevention and Protection Act, communicable diseases as defined in Article 3, Paragraph 1 of the Communicable Disease Control Act, or other significant incidents.
3.Other circumstances beyond the control of the installed institution.
If the activation is not completed within the periods specified in the preceding two paragraphs, the central authority may annul their permit.
For the installed institutions that have obtained hazardous medical device installation permits before the amendment of this Regulation on October 19, 2022, the five-year period specified in Paragraph 1 shall commence from the date of the aforementioned amendment’s enforcement.
Article 7
In case the hazardous medical device is wasted or no longer in use, the installed institute shall report to the central authority within 30 days for recordation.
Article 8
The Guideline is effective upon promulgation.