Regulations for the Assessment and Approval Process of Hazardous Medical Device 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.