FAQ
Medical Devices

I wish to apply for exemption from the requirement for pre-clinical and quality control testing documents submission using a certificate of market approval issued by the government or competent authority of the United States or the European Union. Are there any details that I should note?

刊登日期:2019-07-11  |  點閱次數 : 122 次 

According to Article 12 of the Regulations for Registration of Medical Devices, test specifications and methods, original test records, and test reports of the pre-clinical tests and quality control tests conducted by the original manufacturer refer to information related to safety and functional testing conducted to ensure the claimed efficacy, structure, materials, design, and quality of the product.

Regarding the application for registration, change in specification, or efficacy of a class II medical device with a predicate product approved to market by the central competent health authority, the preclinical testing documents may be substituted by any of the following documents:

(1)  An affidavit for the preclinical testing documents in conformity with the proclaimed items of Taiwan’s competent national health authority.

(2)  A certificate of market approval issued by the government or other competent authority of the United States, or any member state of the European Union. The efficacy and indication of the device should be consistent with those described in the abovementioned certificate.

It should be noted that the simplified method mentioned in the preceding paragraph can only be used to obtain an exemption for the submission of preclinical testing and quality control testing documents, and this method is only applicable to class II medical devices with a predicate product approved for the domestic market. This method is not applicable if a class III medical device or a medical device without any predicate product.  

The application documents in the preceding paragraph exempted from submitting shall be kept in the plant for possible inspection. The central competent health authority may order its submission when necessary.

Acceptable market approval certificates issued by the government or other competent authority of the United States or European Union mentioned in the preceding paragraphs are as follows:

 

● There are two acceptable forms of market approval certificate issued by the United States:

(1) An original copy of the Certificate to Foreign Government (CFG) issued by the United States Food and Drug Administration (FDA): the regulations applicable to this certificate are the same as those for manufacture and free sale certificates. The difference between the two is that when used for the exemption of pre-clinical and quality control testing documents, the CFG does not need to be notarized by the overseas representative organization of Taiwan in the respective country.

(2) Information printed from the FDA website (510[k] Database): Please ensure that the following information is stated clearly on the web page or summary (limited to pages that can be linked directly from the underlined texts on the webpage) (a) full name, model, and specification of the product and (b) name and address of the manufacturer (if the information listed in the “applicant” section of the page is not the name and address of the actual manufacturer, the information printed from the page regarding the medical device cannot be used as a market approval certificate). Because market approval certificates are documents that must be officially issued, they cannot be substituted with explanatory letters from the original manufacturer.

 

●  Acceptable forms of market approval certificate issued by member states of the European Union:

(1) Original copy of the medical device manufacture and free sale certificate (FSC) issued by the government or other competent authority of the relevant member state of the European Union: for an official list of member states of the European Union, please refer to the official website of the Taiwan Ministry of Foreign Affairs. Please note that certain European countries (e.g., Switzerland and Liechtenstein) are not member states of the European Union.  

(2) Market approval certificate issued by a notified body of the European Union: An original copy of the market approval certificate is required. The following information should be clearly stated on the certificate: address, product name, model, specification, and any textual description that indicates the product can be freely marketed in the European Union area (e.g., can be freely sold, may be marketed, or any other textual descriptions with a similar meaning). Please note that notified bodies are limited to organizations that are qualified to conduct medical device conformity reviews in the European Union (93/42/EEC; medical devices, 90/385/EEC active implantable medical devices; 98/79/EC In Vitro Diagnostic Reagents). These notified bodies should be listed and traceable on the official website of the European Union. The name and address of the notified body listed on the market approval certificate should match that listed on the official website of the European Union.

 

●  European Certificate (EC):

The certificate should contain complete information about the product, including name, model, specification, name of the manufacturer, and textual description indicating that the product can be freely marketed in the European Union (e.g., keywords such as market, free sale, or any order textual descriptions with a similar meaning). The following information about the EC should be noted:

(1) If the EC does not contain the keyword “manufacturer” but uses the keyword “issue to” instead, the ISO 13485 certificate of the original manufacturer should be attached to the application. This is to enable verification of the match between the manufacturer’s names and addresses printed on both certificates.

(2) If the EC does not list the name, model or specification of the product but lists the scope of the product (e.g., intravascular catheter, IV administration set), the original statement letter issued by the relevant notified body should also be attached. The statement letter should clearly state the name, model, and specification of the product.   

(3) If the notified body listed the name, model, and specification of the product on another document and attached it to the statement letter, the attached document should either: (a) bear the seal and signature from the notified body on every page; or (b) be stapled to the statement letter and placed in a sealed envelope. A seal of the notified body shall be stamped on adjoining edges of the document (fan stamped) and also on the flap of the envelope after it has been sealed. This is to ensure that the attachment and the explanatory letter belong to the same document.

All attached documents mentioned in the preceding three items cannot be substituted by a statement letter issued by the original manufacturer.

 


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