For approved application for registration in this chapter, except for reissuance for damaged or lost medical device permit license, any change to medical device permit license shall be annotated with change items, change date, and stamped by the central health competent authority and then returned. In the event of reissuance, license fee shall be paid.

For application of change of Chinese product name, the following documents shall be submitted:
1.Application form for change in medical device permit license.
2.Original copy of the medical device permit license.
3.Relevant documents shall be attached if a trademark is being registered.

For application of change of English product name, the following documents shall be submitted:
1.Application form for change in medical device permit license.
2.Original copy of the medical device permit license.
3.Original manufacturer covering letter that explains the change in product name.
4.The original copy of the manufacture and free sale certificate of the country of origin; its content shall indicate the product applying for change in product name and the already approved product are in fact the same.
5.Relevant documents shall be attached if a trademark is being registered.
In the event of applying for change in product name for a domestically manufactured medical device, Subparagraph 4 of the preceding paragraph shall be exempted.

The following documents shall be attached when applying for change of the original manufacturer's instructions, label, or packaging on a medical device permit license:
1.Application form for change in medical device permit license.
2.A comparison table of the change and the original content.
3.Original copy of the medical device permit license.
4.Original copy of the already approved instruction leaflet stamped with tally impression of the central health competent authority.
5.Original copy of a letter of explanation from the original manufacturer concerning the changes to instructions, label, or packaging.
Two copies of each of the following item: the affixed or stapled to the label attachment form of the new version of instructions and manual with detailed Chinese translations, packaging, labels and color pictures of the physical appearance of product.

The following documents shall be attached when applying for change of the specifications on a medical device permit license:
1.Application form for change in medical device permit license.
2.Original copy of the medical device permit license.
3.Original copy of the already approved instruction leaflet stamped with tally impression of the central health competent authority.
4.Two copies of each of the following items: the affixed or stapled to the label attachment form of instructions and manual with detailed Chinese translations, packaging, labels and color pictures of the physical appearance of product.
5.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.
6.One copy of each of the relevant documents concerning product structure, materials, specifications, performance, intended uses, and drawings, etc. For instrument product, an operation manual or a service manual covers all of the abovementioned items may be a substitution.
7.The original copy of the comparison and explanation of the changed specifications and the originally approved specifications issued by the original manufacturer;
8.The original copy of the manufacture and free sale certificate of the country of origin.
9.The original copy of foreign original manufacturer authorization letter.
10.Two copies of radiation safety information for equipment generating ionizing radiation.
The documents in The documents in Subparagraphs 8 and 9 of the foregoing Paragraph may be waived when applying to change a domestically-manufactured medical device permit license.
The application for change of the specifications of a medical device shall be in conformity with the preceding two paragraphs if such a device is a Class III IVD. Moreover, if the IVD is required to undergo testing, as announced by the central health competent authority, two (2) copies of the documents specified in Subparagraph 5 of Paragraph 1 shall be submitted, and submission for testing shall be required.
The medical device applying for registration in Paragraph 1 shall be in conformity with related rules or regulations announced by the central health competent authority, and the documents exempted from submission shall be kept in the manufacturing factory. The central health competent authority may order its submission when necessary.

The following documents shall be attached when applying the nullification of specifications on a medical device permit license:
1.Application form for change in medical device permit license.
2.Original copy of the medical device permit license.
3.Original copy of the already approved instruction leaflet stamped with tally impression of the central health competent authority.

The following documents shall be attached when applying for change in medical device efficacy, indication, performance, instruction for use, or dosage on a medical device permit, the following documents shall be submitted:
1.Application form for change in medical device permit license.
2.Original copy of the medical device permit license.
3.Original copy of the already approved instruction leaflet stamped with tally impression of the central health competent authority.
4.Two copies of each of the following items: the affixed or stapled to the label attachment form of instructions and manual with detailed Chinese translations, packaging, labels and color pictures of the physical appearance of product.
5.One copy 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.
6.One copy of each of the relevant documents concerning product structure, materials, specifications, functions, intended uses, and drawings, etc. For instrument product, an operation manual or a service manual covers all of the abovementioned items may be a substitution.
7.The original copy of the manufacture and free sale certificate of the country of origin.
8.The original copy of foreign original manufacturer authorization letter.
9.Theoretical basis and relevant research reports and data.
10.Clinical trial reports.
11. The original copy of the comparison and explanation of the changed particulars and the originally approved particulars issued by the original manufacturer.
In the event of applying for change of a domestically manufactured medical device, Subparagraph 7 and 8 and of the preceding paragraph shall be exempted.
In the event of already a product in the market similar to the medical device applying for changes of Paragraph 1, the documents specified in Subparagraphs 9 and 10 of Paragraph 1 may be waived.
The medical device applying for registration in Paragraph 1 and Paragraph 3 shall be in conformity with related rules or regulations announced by the central health competent authority, and the documents exempted from submission shall be kept in the manufacturing factory. The central health competent authority may order its submission when necessary.

The following documents shall be attached when applying for changing the name of manufacturing factory on a medical device permit license:
1.Application form for change in medical device permit license.
2.Original copy of the medical device permit license.
3.Original manufacturer covering letter that explains the change in manufacturing factory name.
4.Photocopy of pharmaceutical firm permit license of the manufacturing factory with the new name.
5.Original copy of the manufacture and free sale certificate of the country of origin.
6.The original copy of foreign original manufacturer authorization letter.
7.Documents verifying that the manufacturing factory in conformity with the GMP for Medical Devices.
In the event of applying for change in manufacturing factory name for an imported medical device, Subparagraph 4 of the preceding paragraph shall be exempted.
In the event of applying for change in manufacturing factory name for a domestically manufactured medical device, Subparagraph 5 and 6 of Paragraph 1 shall be exempted.
In the event the domestically manufactured medical device applying for the change and the changed manufacturing factory is a commissioned one, in addition to the previous two paragraphs, it shall be in conformity with the Regulations for Medicament Contract Manufacture and Analysis.

The following documents shall be attached when applying for change in address of manufacturing factory (including the country of origin):
1.Application form for change in medical device permit license.
2.Original copy of the medical device permit license.
3.Original manufacturer covering letter that explains the change in manufacturing factory address.
4.Photocopy of pharmaceutical firm permit license of the manufacturing factory with the new address.
5.Original copy of the manufacture and free sale certificate of the country of origin.
6.The original copy of foreign original manufacturer authorization letter.
7.Documents verifying that the manufacturing factory in conformity with the GMP for Medical Devices.
In the event of applying for change in manufacturing factory name for an imported medical device, Subparagraph 4 of the preceding paragraph shall be exempted.
In the event of applying for change in manufacturing factory name for a domestically manufactured medical device, Subparagraph 5 and 6 of Paragraph 1 shall be exempted.
If change of the manufacturing factory address was due to house-numbering system change, document for Subparagraph 5 of Paragraph 1 may be exempted, a certificate issued by government shall be submitted; in the case of imported medical devices, the certificate shall be notarized by R.O.C (Taiwan) foreign affairs office.
In the case of a Class III IVD, the application for change shall be in conformity with the preceding four paragraphs. Moreover, two (2) copies of the documents stating the test specifications and methods for pre-clinical testing and quality control conducted by the original manufacturer, the original test records, and the test result reports shall be submitted. If the IVD is required to undergo testing, as announced by the central health competent authority, submission for testing shall also be required.
For medical devices for which an application for change of the address of the manufacturing factory is submitted in accordance with Paragraph 1, the central health competent authority may, if necessary, order submission of technical documentation such as relevant documents concerning product structure, materials, specifications, performance, intended use, drawing and others, and documents of pre-clinical testing, and the test results of quality control of the original manufacturer.

The following documents shall be attached when applying for transferring the right of the medical device permit license holder:
1.Application form for change in medical device permit license.
2.Original copy of the medical device permit license.
3.Original copy of a permit letter of assignment from the pharmaceutical firm transferring agency rights (assignor).
4.An affidavit from the pharmaceutical firm receiving agency rights (assignee) affirming responsible for the transferred medicament.
5.Original copy of the foreign original manufacturer's authorization certificate; its content shall explain in detail about termination of the rights of the transferor, and bestowing of such rights to the transferee, and shall state the product name and the names and addresses of assignor and assignee, and the certificate shall be valid with one year from the date of issuance by the original manufacturer.
6.Affidavit (A).
7.Photocopy of pharmaceutical firm license of the assignee.
Application for registration shall be applied by the transferor and the transferee jointly.

An application for transfer registration shall be made in accordance with regulations of Article 29 when a change in the name of the pharmaceutical firm holding a medical device permit license involves the transfer of rights.
The following documents shall be attached when applying for a change in the name of the pharmaceutical firm holding a medical device permit license when the transfer of rights is not involved:
1.Application form for change in medical device permit license.
2.Original copy of the medical device permit license.
3.Photocopy of pharmaceutical firm permit license after the name change.
4.One affidavit from the pharmaceutical firm after name change affirming responsible for every item on the changed permit.
5.One affidavit that claims no transfer of rights involved in this application for change in name of the pharmaceutical firm.

The following documents shall be attached when applying for re-issuance of a lost or damaged medical device permit license:
1.Application form for change in medical device permit license.
2.The original copy of the original permit license must be attached when applying for re-issuance of a damaged permit.
3.In the event of the original license being lost, an affidavit stating that the original permit license indeed being lost must be attached.
4.One original and one photocopy of the medical device registration application form.

In the event of application for change in Class I medical device registration, in addition to complying articles in this chapter, Articles 14 and 16 shall be applied mutatis mutandis.

In the event of application for change in medical device registration exclusively for export, in addition to complying articles in this chapter, Article 15 shall be applied mutatis mutandis, to simplify the required documents.