If registration particulars of the license, labels, instructions, or packaging are changed relating to any of the following subparagraphs, documents and information in Appendix 4 shall be submitted and fee shall be paid for submission of an application to the central competent authority:
1. Chinese product name.
2. English product name.
3. Labels, instructions, or packaging.
4. Ingredients, materials, structures, specifications, or model number.
5. Effectiveness, intended use, or indication.
6. Name of the manufacturer.
7. Address of the manufacturer or country of manufacture.
8. License holder.
9. Name of the license holder.
10. Manufacturing license number.
When the approved document of license or labels, instructions, or packaging is lost or damaged, documents and information in Appendix 4 shall be submitted and fee shall be paid to apply for replacement or re-issuance.
If the central competent authority finds that documents and information referred to in the preceding two paragraphs are not ready such that corrections can be made, it shall notify the applicant to make corrections within three months. Failure to make corrections by the designated deadline shall subject the application to rejection.
For applications of re-issuance or replacement of license as referred to in Paragraph 2, the applicant shall, within three months after the arrival date of the notice, pay the license fee and obtain the license from the central competent authority. Failure to obtain the license by the deadline may subject its license to cancellation by the central competent authority.
For applications referred to in Paragraphs 1 and 2, the central competent authority shall annotate the original license with the changed registration particulars and date, and return it after stamping.

• Appendix 4：Documents and information that shall be submitted for an application of change, re-issuance, or replacement of medical device license.pdf

For items announced by the central competent authority to apply for the change referred to in Subparagraph 4 or 7 of Paragraph 1 of the preceding article, the provisions of Paragraph 2 of Article 3 shall apply mutatis mutandis.

Under any of the following circumstances, license holders may, of their own accord, change labels, instructions, or packaging of the medical devices, and such changes shall be documented accordingly:
1. No changes in the text content:
(1) Only changing the material, shape, graphic design, color or luster of labels, instructions, or outer box and the graphic design not being offensive, indecent, or misleading.
(2) Due to different packaging quantities, resizing the approved graphic design or text to fit a different size of packaging, or repositioning the approved graphic design or text.
(3) Changing the fonts of the approved text, and its font size of English text not being larger than that of Chinese text for the product name.
(4) Adding printings on outer boxes or using new outer boxes to replace the affixed labels, and their design of text and graphs being identical to those in the originally approved labels.
2. Changes of the following text content:
(1) Adding or changing barcode, recycling mark, “QMS/GMP” characters of a medical device QMS/GMP manufacturer, CE mark, suggested retail price, customer service telephone line, manufacturer’s telephone number, fax number, contact office, copyright registration number or company trademark approved by Taiwan Intellectual Property Office, CNS mark or trademark registration number, information of representative in other countries or areas.
(2) Adding or changing distributor’s name or address, and the font size of distributor’s name not larger than that of medical device manufacturer’s (license holder’s) name.
(3) Adding or changing the name of medical device firm, or the name or address of manufacturer that has been approved for change by the central competent authority.
(4) Adding, deleting, or changing the name of medical device firm that has been approved for change by the central competent authority and that constitutes part of the Chinese and English product names.
(5) Adding, deleting or changing international symbols representing approval and registration particulars on the license.
3. Adding, deleting or changing the content according to the announcements made in accordance with Subparagraph 10, Paragraph 1, Article 33 of the Act.

For those applying for a change of Class 1 medical device, the provisions of Article 5 shall apply mutatis mutandis to the submission of their documents and information.

For those applying for a change of medical device exclusively for export, the provisions of Article 6 shall apply mutatis mutandis to the submission of their documents and information.