名 稱 醫療器材查驗登記審查準則 英
修正日期 民國 103 年 09 月 05 日
法規類別 行政 ＞ 衛生福利部 ＞ 食品藥物管理目
第 17 條
理者，自本準則 103 年 9 月 5 日修正發布日起三年內。
Article 17 For application of registration and market approval for imported Class II or Class III medical devices, the following document shall be submitted for review:
1.One copy of 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 affixed or stapled to the label attachment form of instructions and manual with detailed Chinese translations, packaging, labels and color pictures of the physical appearance of product.
3.A photocopy of pharmaceutical firm permit license as a medical device dealer.
5.The original copy of the manufacture and free sale certificate of the country of origin.
6.The original copy of the foreign original manufacturer authorization letter.
7.Documents verifying that the domestic manufacturing factory in conformity with the GMP for Medical Devices.
8.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.
9.One copy of each of the relevant documents concerning product structure, materials, specifications, performance, intended uses, and drawings, etc. For instrument product, an operation manual or a service manual covers all of the above-mentioned items may be a substitution.
10.Theoretical basis and relevant research reports and data.
11.Clinical trial reports.
12.Two copies of radiation safety information for equipment generating ionizing radiation.
Documents of the Subparagraphs 7 in the preceding paragraph, in accordance with any of the followings, may be substituted with photocopies of documents verifying compliance with the 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 10 and 11 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 11 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.
IVD applying for registration and market approval shall be in conformity with the preceding five paragraphs and proclamations by the central health competent authority; IVDs listed as Class III according to the Regulations for Governing the Management of Medical Device and announced as the item required testing by the central health competent authority shall also submit for testing.
The Class III medical device applying for registration and market approval, shall submit documents of Essential Principles (EP) and Summary of Technical Documentation (STED) in accordance with Appendix.
In the event of the medical device applying for registration is commissioned to manufacture or analysis, in addition to conformity with the preceding seven paragraphs, conformity with the Regulations for Medicament Contract Manufacture and Analysis shall also be required.
The medical device applying for registration according to the Paragraph 1 shall be in conformity with related rules or regulations announced by the central health competent authority; document exempted from submission shall be kept at the manufacturing factory for possible inspection, The medical device applying for registration and market approval in the Paragraph 1 shall be in conformity with related rules or regulations announced by the central health competent authority, and documents exempted from submission shall be kept. The central health competent authority may order its submission when necessary.