FAQ
Medical Devices

What are the conditions and restrictions for registration for an already-approved product under a different name? What are the documents in preparation for application?

刊登日期:2019-07-11  |  點閱次數 : 92 次 

Other than product name (which should be different), the characteristics (e.g., content of the package insert and label, specification, and model) of the medical device for registration review should be identical to the already-approved medical device. 

When submitting an application for the registration for an already-approved product under a different name, please refer to Article 18 (for domestic medical devices) or Article 19 (for imported medical devices) of the Regulations for Registration of Medical Devices for information on documents to be attached to the application. 

(1) Domestic medical devices:the application should be made by the original medical device license holder, or a pharmaceutical firm authorized by the original medical device license holder, with the following documents provided:

a. The Medical Device Registration Application Form (original copy and duplicate copy) (Chinese version only).

b. Two copies of Sticking Label and Package Insert Form including: Chinese package insert, instructions for use, packaging, and label affixed or stapled to the Label Attachment Form, as well as color pictures of the physical appearance of the product.

c. Affidavit (A)

d. A description letter from the original manufacturer stating that the product for which a new application is to be made and the originally approved product are identical, and noting the license number of the originally approved medical device.

e. Photocopy of the already approved instruction leaflet and labels stamped with tally impression of the central competent health authority

f. A photocopy of the originally approved medical device license.

g. If the new product name bears the name or trademark of another manufacturer, the applicant shall attach a letter of consent from the company whose name or trademark has been used.

*Note:

1. In the event that the pharmaceutical firm applying for registration and market approval is different from the manufacturer, it shall be deemed respectively, as the contractor and contract manufacturer.

2. In the event that the contract manufacturer or analyzer is the applicant for medical device license registration, the applicant shall also fulfill the Regulations for Medicament Contract Manufacture and Analysis.

 

(2) Imported medical devices: the application should be made by the original medical device license holder, or a pharmaceutical company authorized by the original license holder, with the following documents provided:

a. The Medical Device Registration Application Form (original copy and duplicate copy) (Chinese version only).

b. Two copies of Sticking Label and Package Insert Form including: Chinese package insert, instructions for use, packaging, and label affixed or stapled to the Label Attachment Form, as well as color pictures of the physical appearance of the product. 

c. Affidavit (A).

d. Original copy of the manufacture and free sale certificate from the country of origin, which shall explicitly state that the product for which a new application is to be made and the originally approved product are identical.

e. The original copy of the foreign original manufacturer authorization letter.

f.  A description letter from the original manufacturer stating that the product for which a new application is to be made and the originally approved product are identical. The license number of the originally approved medical device should be provided.

g. One copy each of the originally approved package insert and label. The photocopies should bear the competent national health authority’s seal on adjoining edges of the document (fan stamped).

h. A photocopy of the originally approved medical device license.

i. If the new product name bears the name or trademark of another manufacturer, the applicant shall attach a letter of consent from the company whose name or trademark has been used.

*Note:

In the event that the contract manufacturer or analyzer is the applicant for medical device license registration, the applicant shall also fulfill the Regulations for Medicament Contract Manufacturing and Analysis.

 

(中文版)


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