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Laws & Regulations Database of The Republic of China (Taiwan)

Print Time:2023/01/29 22:56
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Article 1
These Regulations are formulated in accordance with Paragraph 2, Article 80 of the Medical Devices Act.
Article 2
The incentive reward recipients under the Regulations are domestic medical device firms and other domestic natural persons, institutions, schools, legal entities or organizations that are engaged in the research and development of innovative medical devices technology.
Article 3
The incentive reward recipients in the preceding article shall possess one of the following eligibilities:
1. Having obtained domestic or foreign invention patents or patent authorizations, as well as domestic or foreign license, approval or registration for medical device manufacturing or import.
2. Having obtained domestic or foreign invention patents or patent authorizations, and also completed domestic or foreign clinical trial research, though having not yet obtained domestic license or registration of medical device manufacturing or import.
3. Domestically manufactured medical devices having obtained domestic or foreign patents, with significant contributions to the development of the medical device manufacturing industry.
4. Domestically manufactured medical devices having important and substantial market values.
5. Materials and components used on domestically manufactured medical devices having significant contributions to the development of the medical device manufacturing industry.
6. Domestically developed new equipment, facilities, devices, manufacturing processes or methods of test and analysis having significant contributions to the enhancement of the manufacturing or testing technologies of medical devices.
7. By supporting the policies of the central competent authority or central industry competent authority, having made significant contribution to the development of the medical device manufacturing industry or the enhancement of the research and development of medical devices.
8. Other significant contributions recognized by the central competent authority in conjunction with the central industry competent authority.
Article 4
Applications for the incentive rewards shall be made with the application form submitted to the central competent authority with the following documents and materials as affixes:
1. For applications based on Subparagraph 1 of the preceding article:
(1) Patent certificate, patent authorization letter or technology authorization letter.
(2) License, approval or registration certificate for medical device manufacturing or import.
2. For applications based on Subparagraph 2 of the preceding article:
(1) Patent certificate, patent authorization letter or technology authorization letter.
(2) Clinical trial report or human trial report.
3. For applications based on Subparagraph 3 of the preceding article:
(1) Domestic manufacturing license.
(2) Patent certificate.
(3) Technical specifications.
(4) Evidence of significant contribution.
4. For applications based on Subparagraph 4 of the preceding article:
(1) Domestic manufacturing license.
(2) Evidence of important and substantial market values.
5. For applications based on Subparagraph 5 of the preceding article:
(1) Technical or product specifications of materials and components.
(2) Evidence of significant contribution.
6. For applications based on Subparagraph 6 of the preceding article:
(1) Description of new equipment, facilities, devices, manufacturing processes or methods of test and analysis.
(2) Evidence of significant contribution.
7. For applications based on Subparagraphs 7 and 8 of the preceding article: Description and evidence of significant contribution.
The incentive rewards set forth in the Regulations may be made through recommendation by the central competent authority or the central industry competent authority, in which case the nominees shall be notified to submit the application with relevant documents and materials to the central competent authority in accordance with the provisions of the preceding paragraph.
Article 5
The central competent authority, in order to review the cases of application or recommendation of the preceding Article, may organize the Review Committee on the Research and Development of Innovative Medical Devices Technology (hereinafter referred to as the Review Committee).
The Review Committee shall have nine to thirteen members appointed by the head of the central competent authority from among scholars, experts and representatives of academic institutions, science and technology industries, and personnel from the competent authority or related entities. One of them shall be the convener, as designated by the head of the central competent authority.
Meetings of the Review Committee can be held only with more than half of all the members present. Resolutions can be made only with the consent of more than half of all the members present.
Committee members that are scholars and experts shall attend the meetings in person and shall not exercise their rights by proxy. Committee members that are representatives of institutions (entities) and industries may have personnel with related functions serve as their proxies respectively in discussion and voting if they cannot attend the meetings.
The recusal of committee members in the meetings shall be handled in accordance with the provisions of the Administrative Procedure Act.
Article 6
The incentive rewards under the Regulations are in the format of merit citations, trophies, or cash rewards.
Article 7
The funding for the incentive rewards under the Regulations shall be raised in the following manners:
1. The annual budget of the central competent authority and the central industry competent authority.
2. Donations from individuals or organizations designated for the purpose of incentive rewards under these Regulations.
Article 8
These Regulations shall be implemented on May 1, 2021.
Web site:Laws & Regulations Database of The Republic of China (Taiwan)