Standards of Review Fees for the Registration of orphan drug｜第 3 條｜Food and Drug Administration｜Regulation｜In Force
衛生福利部｜v1.0
Last Amended: 2021-09-29
To apply for registration and market approval of medical devices for rare diseases, the following review fees shall be paid for each application: 1. Priority review for registration and market approval of a medical device for a rare disease: TWD 54,000. 2. Registration and market approval for a medical device with new working principle, new structure, new material, new effectiveness, or with no predicate device(s): TWD 39,000. 3. Inspection of a medical device quality management system: TWD 11,400. 4. Change of registration particulars for the license and license extension: (1) Change of effectiveness, intended use or indication: TWD 12,000. (2) Change of specification: TWD 7,500. (3) Transfer, merger, change of production site or manufacturing site: TWD 7,500. (4) Other changes: TWD 3,000. (5) Re-issuance of approved document of labels or instructions for the license: TWD 3,000. (6) License extension: TWD 2,400. 5. Related certificates and documents: (1) Free sale certificate in Chinese or English: TWD 540. (2) Manufacturing certificate in Chinese or English and re-issuance of an approved manufacturing certificate: TWD 540. 6. Issuance, re-issuance or replacement of license: TWD 450. Applications of the change listed in Item 3, Subparagraph 4 of the preceding Paragraph are limited to one manufacturing site per application. Applications of free sale certificate listed in Item 1, Subparagraph 5 of Paragraph 1 are limited to one license for each application. Applications of the certificate and documents listed in Subparagraph 5 of Paragraph 1 are limited to three copies per set for each application.