For application of registration and market approval for domestically manufactured Class 2 or Class 3 medical devices, the following documents shall be submitted for review:
1.One copy each of the original and photocopy of the medical device registration and market approval application form.
2.Two copies of each of the following items: the form for attaching outer box instruction label with all Chinese instruction leaflet catalog packaging, and labeling, instructions for use, and color pictures of the physical appearance of product.
3.A photocopy of pharmaceutical firm permit license as a medical device manufacturer.
4.Affidavit (A)
5.Documents verifying that the domestic manufacturing factory is in conformity with the GMP for Medical Devices.
6.One copy of each of the follwing items: pre-clinical testing and the test specifications and methods, the original test records, and the test reports of the quality control conducted by the original manufacturer.
7.One copy of each of the relevant documents concerning product structure, materials, specifications, performance, intended uses, and drawings, etc. For instrument products, an operation manual or a service manual covers all of the above-mentioned items may be a substitution.
8.Theoretical basis and relevant research reports and data.
9.Clinical trial reports.
10.Two copies of radiation safety information for equipments generating ionizing radiation.
Documents of the Subparagraphs 5 in the preceding paragraph, in accordance with any of the followings, may be substituted with photocopies of documents verifying compliance with the Good Manufacturing Practices for Pharmaceuticals in accordance with the Part 2 of the Pharmaceutical Good Manufacturing Practice Regulations (hereafter referred to as GMP for Pharmaceuticals):
1.The medical device applying for registration and market approval was regulated as pharmaceutical product before. This rule applies within three years from the date of proclamations of listing change.
2.The medical device was regulated as a pharmaceutical product before January 1, 2013. This rule applies within three years from the promulgation date of the September 5, 2014 amendment to this Regulation.
The central health competent authority shall determine or announce whether the medical device applying for registration and market approval requires clinical trials in Taiwan in light of the medical device product item, the case, and the materials submitted.
In the event of already a product in the market similar to the medical device applying for registration, except where other regulations apply, the documents specified in Subparagraphs 8 and 9 of Paragraph 1 may be waived. However, the applicant shall additionally attach a domestic clinical trial report when clinical trials in Taiwan are required in accordance with the foregoing Paragraph.
In the event of applying for registration and market approval of Class 2 medical devices with no predicate product previously approved to market by the central health competent authority, the documents specified in Subparagraphs 9 of Paragraph 1 may be waived if the medical device is in conformity with the related simplified rules or regulations announced by the central health competent authority. However, a domestic clinical trial report shall be submitted when a domestic clinical trial is required according to Paragraph 3.
In the event of applying for registration of medical devices exclusively for export, submissions for testing are not required, and documents required by Subparagraphs 6 to 10 of Paragraph 1 shall be exempted.
The registration and market approval of IVDs shall be in conformity with the preceding six paragraphs and announcements by the central health competent authority. For the IVDs listed as Class III according to the Regulations for Governing the Management of Medical Device and required to undergo testing, as announced by the central health competent authority, two (2) copies of the documents specified in Subparagraph 6 of Paragraph 1 shall be submitted, and submission for testing shall be required, except for products exclusively for export.
The medical devices applying for Class III registration and market approval, except products exclusively for export, shall also submit documents of Essential Principles (EP) and Summary of Technical Documentation (STED) in accordance with Appendix.
In the event of the pharmaceutical firm applying for registration and market approval different from the manufacturer, it shall be deemed as commission manufacturing.
In the event of the medical device applying for registration and market approval is commissioned to manufacture or testing, the device shall be in conformity with the preceding nine paragraphs and the Regulations for Medicament Contract Manufacture and Analysis.
The medical device applying for registration in Paragraph 1 and Paragraph 6 shall be in conformity with related rules or regulations announced by the central health competent authority, and the documents exempted from submission shall be kept in the manufacturing factory. The central health competent authority may order its submission when necessary.