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化妝品、食品、藥物與醫療器材法律專題(二)

Medical Device Merchant Incorporation (II)

Charlotte Wu / Zhong Yin Law Firm

Given the current pandemic, we have received frequent inquiries on Taiwan regulations regarding medical device registration and medical device merchant incorporation and relevant licensing and/or permit issues. We have summarized the frequently asked questions and provide a general overview for those who are interested in this topic. Should you have any further interests or questions, please feel free to contact Charlotte Wu at charlotte.wu@zhongyinlawyer.com.tw

Ⅲ. Taiwan Regulations on Medical Device Permit License

In accordance to Article 13 of the Pharmaceutical Affairs Act, “the term ‘medical device’, as used in this Act, shall refer to any instruments, machines, apparatus, materials, software, reagent for in vitro use, and other similar or related articles, which is used in diagnosing, curing, alleviating, or directly preventing human diseases, regulating fertility, or which may affect the body structure or functions of human beings, and do not achieve its primary intended function by pharmacological, immunological or metabolic means in or on the human body.” Moreover, according to Paragraph 1, Article 40 of Pharmaceutical Affairs Act, “for the manufacturing and import of medical devices, an application together with fees paid, shall be filed with the central competent health authority for registration and market approval. No manufacturing and importation shall be allowed until a medical device permit license is approved and issued.”

If an item is a medical device under the Pharmaceutical Affairs Act, it shall be registered and approved before being manufactured and imported. This article will further introduce the classification of medical device under Taiwan Law and summarize the process of how to register a medical device.

1.The Classification of Medical Device under Taiwan Law:

(1) Class I Device: Low Risk medical device

(2) Class II Device: Moderate Risk medical device

(3) Class III Device: High Risk medical device

(4) PMA: New Medical Devices, refers to devices that are not previously approved by the TFDA. In other words, if there are no similar devices previously approved by the TFDA, the device will be considered a PMA device in Taiwan.

2. Classifying the medical device before registration:

According to Article 6 of the Regulations for Governing the Management of Medical Device, “[a] pharmaceutical entity or the general public may approach the National Health Competent Authority, through a payment service, for inquiry of the classification of a medical device and its regulatory control with the provision of the following: (i) Instruction for use (or catalogue) and its Chinese translation in details (including the instruction for use, function and working principle); (ii) Reference to classification of the product by the European Union or United State of America; and (iii) Any other information as defined by the National Health Competent Authority.”

It is suggested to file an application for classifying the medical device with TFDA before registration to avoid misclassification of the registration of the medical device. The processing period of such classification usually takes 90 days for general cases and 120 days for special cases.

3. How to register class I Medical Devices:

Pursuant to Paragraph 1, Article 14 of the Regulation for Registration of Medical Devices, “for application of registration and market approval of domestically manufactured Class 1 medical devices, the following documents shall be submitted for review:

(i) Application form for Class 1 medical device registration and market approval and original copy of affidavit.
(ii) A photocopy of pharmaceutical firm permit license as a medical device manufacturer. (iii) Documents verifying that the manufacturing is in conformity with the Good Manufacturing Practices for Medical Devices in accordance with Part 3 of the Pharmaceutical Good Manufacturing Practice Regulations (hereafter referred to as GMP for Medical Devices). Product items in accordance with Article 4 Appendix II of the Regulations for Governing the Management of Medical Device are exempted from this subparagraph.”

A pharmaceutical firm applying for registration and market approval for class I Medical Devices shall submit an application form and the abovementioned documentations in writing or online to the TFDA. The estimated processing period of such registration is 80 working days.

4. How to register class II Medical Devices and class III Medical Devices:

Pursuant to Paragraph 1, Article 15 of the Regulation for Registration of Medical Devices, “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:

(i) One copy each of the original and photocopy of the medical device registration and market approval application form.
(ii) 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.
(iii) A photocopy of pharmaceutical firm permit license as a medical device manufacturer. (iv) Affidavit (A)
(v) Documents verifying that the domestic manufacturing factory is in conformity with the GMP for Medical Devices.
(vi) One copy of each of the following 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.
(vii) 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.
(viii) Theoretical basis and relevant research reports and data.
(ix) Clinical trial reports.
(x) Two copies of radiation safety information for equipment generating ionizing radiation.”

Pharmaceutical firms applying for the registration and market approval for class II and class III Medical Devices shall submit an application form and the abovementioned documentations in writing to the TFDA. The processing period of such registration will depend on whether a similar medical device has been previously approved.