General Information on Draft Partial Amendment to the Regulation for Registration of Medical Devices (41 pages, in English; 22 pages, in Chinese)

This Regulation was established in accordance with Paragraph 3, Article 40 of the Pharmaceutical Affairs Act to meet the needs for registration and market approval of medical devices and management of permit licenses, and was promulgated and came into force as per the Decree of Wei-Shu-Yao-Zi No. 0930328238 on 30 December 2004. This Regulation has undergone five amendments since then. In order to improve the registration and market approval process and ensure the safety and efficacy of medical devices on the market, a draft partial amendment to the Regulation for Registration of Medical Devices has been formulated. The main points of the amendment are as follows:

1.  With the provisions of Paragraph 3 of Article 3 and Article 13 of the Regulations for Registration of Medicinal Products as reference, it is stipulated that a Chinese or English translation shall be provided if the documents submitted are not made in Traditional Chinese or English (amendment to Article 3) .

2.  Considering that the current relationship between the commissioning company and the commissioned manufacturing factory is not proved by a manufacture certificate but by a commissioning contract signed by the parties and other relevant documents in accordance with the Regulations for Medicament Contract Manufacture and Analysis, the relevant provisions that require a clear description of the relationship between the commissioning company and the commissioned manufacturing factory in a manufacture and free sale certificate of the country of origin, as set forth in the latter part of Paragraph 3, are deleted (amendment to Article 7) .

3.  To meet the needs for e-government, online application services have become available for Class I medical devices. The applicant may sign or affix their seal to confirm their identity if an application is submitted in writing. However, if a registration application is submitted online, the identity of the applicant must be confirmed by means of electronic signature since the applicant is unable to sign or affix their seal. As a result, the latter part of the paragraph explicitly stipulates that those submitting an application online shall do so with the IC card issued by the Certificate Authority of the Ministry of Economic Affairs (amendment to Articles 14 and 16) .

4.  Changes in the specifications or efficacy of a medical device shall be done after evaluated by the original designer or manufacturer of the product, so as to ensure the safety and efficacy of the product. Therefore, the amendment requires that the comparison and explanation of the changed specifications or efficacy and the originally approved specifications or efficacy submitted for the purpose of applying for change of the specifications or efficacy on a permit license shall be issued by the original medical device manufacturer (amendment to Articles 24 and 26) .

5.  Paragraph 6 is added to prevent the change of the address of a medical device manufacturing factory from resulting in any inconsistency with its medical device previously approved for registration and market approval in terms of the quality, safety, and efficacy. The central competent authority may order the applicant to submit relevant supporting documents to confirm the consistency with its medical device previously approved for registration and market approval (amendment to Article 28) .

6.  To avoid other factors that affect the safety and efficacy of the product concerned due to extension or change of a permit license, the rights of the central health competent authority to order the applicant to submit relevant documents are reserved, thereby ensuring the efficacy and safety of the product (amendment to Article 35) .

7.  To collect complete information on the instructions of Class I medical devices and improve the management after launch to the market, it is explicitly stipulated that Class I medical device permit license holders shall upload the instructions, labels, and outer box documents to the information system specified by the central health competent authority within one (1) month after obtaining permit licenses or within six (6) months after the amendment to this Regulation comes into force if they obtain Class I medical device permit licenses before the amendment to this Regulation comes into force. Moreover, such uploading is listed as a requirement for applying for extension of Class I medical device permit licenses (amendment to Articles 35 and 36) .

8.  Since the review process for medical devices exclusively for export is different from that for domestically manufactured medical devices, it is explicitly stipulated that the Chinese and English names of medical devices exclusively for export shall not be the same as those of domestically manufactured medical devices. Thus, any confusion between medical devices exclusively for export and domestically manufactured medical devices can be avoided (amendment to Article 37) .