Guidelines for the Examination of Medical Device Registration / Explanation of the Draft Amendment to Certain Articles

These Guidelines are established pursuant to Article 40, Paragraph 3 of the Pharmaceutical Affairs Act for the needs of handling the examination of medical device registration and the management of licenses, and were promulgated and put into effect on December 30, 2004 by the Department of Health Order Wei-Shu-Yao-Zi No. 0930328238, having undergone five amendments since. However, in order to refine the examination of registration and ensure the safety and efficacy of marketed medical devices, a draft amendment to certain articles of the “Guidelines for the Examination of Medical Device Registration” is hereby proposed. The key points of the amendment are as follows:

1. With reference to Article 3, Paragraph 3 and Article 13 of the Guidelines for the Examination of Drug Registration, it is expressly stipulated that if the submitted materials are not prepared in Traditional Chinese or English, a Chinese or English translation shall be attached (amended Article 3).

2. Considering the current relationship between the consignor and the consigned manufacturer, which is not evidenced by a manufacturing certificate but rather by documents such as a consignment manufacturing contract signed by both parties in accordance with the Regulations for Consigned Manufacturing and Testing of Drugs, the latter part of Paragraph 3 regarding the requirement that the manufacturing and marketing certificate of the country of origin state the relationship between the consignor and the consigned manufacturer is deleted (amended Article 7).

3. To meet the needs of electronic government, an online application service is added for low-risk Class I medical devices. For written applications, the applicant company may prove identity by signature or seal; for online registration applications, since the applicant cannot sign or seal, identity must be identified through electronic signature, and thus the latter part of this paragraph states that online applications shall be made using an industrial and commercial certificate issued by the Ministry of Economic Affairs’ Commerce Industrial Certificate Authority (amended Articles 14 and 16).

4. Because changes to the specifications and efficacy of a medical device product should be made after evaluation by the original designer and manufacturer of the product in order to ensure the product’s safety and efficacy, the comparison and explanation of the differences between the proposed changed specifications and efficacy and the originally approved ones, issued for an application to change the specifications and efficacy of a license, shall be issued by the original manufacturer of the medical device (amended Articles 24 and 26).

5. To avoid situations where a change in the factory address of a medical device manufacturer causes the quality, safety, and efficacy of the medical device product to be inconsistent with the original registration approval, a new Paragraph 6 is added stipulating that the central competent authority may order the applicant company to submit relevant supporting documents to confirm consistency with the original registration approval (amended Article 28).

6. To avoid other factors affecting product safety and efficacy when a license is extended or changed, the right of the central health competent authority to require the applicant company to submit relevant materials is retained, in order to ensure the product’s efficacy and safety (amended Article 35).

7. To improve the package insert information of Class I medical devices and refine post-market management, it is expressly stipulated that holders of Class I medical device licenses shall, within one month after obtaining the license, and those who obtained a Class I medical device license before the amendment of these Guidelines took effect shall, within six months after the amendment takes effect, upload the package insert, label, and outer box documents to the information system designated by the central health competent authority, and this is listed as a requirement for the extension application of Class I medical devices (amended Articles 35 and 36).

8. Because the examination procedure for export-only medical devices differs from that for domestically produced medical devices, and to avoid confusion between export-only medical devices and domestically produced medical devices, it is stated that the Chinese and English product names of export-only medical devices shall not be the same as the Chinese and English product names of domestically produced medical devices (amended Article 37).

Details of the Food and Drug Administration Announcement

Document Number: Bu-Shou-Shi-Zi No. 1051601110

Date of Issue: October 21, 2016

Attachment: One copy each of the general explanation and the comparison table of the draft amendment to certain articles of the “Guidelines for the Examination of Medical Device Registration.”

Subject: Pre-announcement of the draft amendment to certain articles of the “Guidelines for the Examination of Medical Device Registration.”

Basis: Article 151, Paragraph 2 of the Administrative Procedure Act, applied mutatis mutandis to Article 154, Paragraph 1.

Announcement Matters:

1. Amending Authority: Ministry of Health and Welfare.
2. Basis for Amendment: Article 40, Paragraph 3 of the Pharmaceutical Affairs Act.
3. The general explanation and comparison table of the draft amendment to certain articles of the “Guidelines for the Examination of Medical Device Registration” are detailed in the attachment; this case is also posted on the Ministry of Health and Welfare [1] under Laws and Regulations, the draft regulations section of the Health Laws Query System, and the “Announcement Area” of the Food and Drug Administration [2] global information website.
4. If you have any opinions or suggested amendments regarding the content of this announcement, please state your opinions or inquire within 60 days from the day after the announcement is published in the gazette: Handling Unit: Food and Drug Administration, Ministry of Health and Welfare.
5. Address: No. 161-2, Kunyang Street, Nangang District, Taipei City 11561.
6. Telephone: 02 27877526.
7. Fax: 02 27878287.
8. Email: [email protected].

Comparison Table of the Draft Amended Articles

• Comparison table of the draft amendment to certain articles of the Guidelines for the Examination of Medical Device Registration: Comparison table of amended articles (PDF).

References

1. Ministry of Health and Welfare of the Republic of China
2. Food and Drug Administration of the Republic of China