Q：In subparagraph 3 of paragraph 7, the guidelines of registration increase criteria mentioned that "shall contain the situation of commissioned manufacturing". Yet every country has their own form of FSC (Certificate for Free-Sale), how should I state it?
A：There’s not a fixed form required on FSC about the manufacture from the entrusted manufacturing plant currently. If you can list the name and address of the entrusted company / entrusted manufacturing plant and show the relationship of them with the entrusted manufacturing contract to corroborated, TFDA will identify leniently.
Q：In the cases that the final packaging and testing of products are finished by entrusted company, so the entrusted company can’t submit the FSC about the name, and address of the entrusted manufacturing plant. Is this factor can be considerate by lenient terms?
A：First, you need to know the differences between parts of manufacturing outsourcing and manufacturing entrusted. If the entrusted manufacturing plant just responsible for parts of manufacturing without the entrusted relationship, then the entrusted manufacturing plant is still commissioned by the manufacturer in this case. In addition, country of origin (COO) is recognized by the national customs which is different from registration, so it cannot put them together to discuss.
Q：Can Taiwan accept the export certificate issued from USA instead of FSC?
A：It is unacceptable. Due to export certificate indicates that the product is not available to sell in the U.S., it is different by FSC.
Q：While applying registration of medical devices, the reviewers are often asked to name and address to be exactly the same. Some of countries (like Netherlands) Ltd. will appear as Oy and caused the problems to applying manufacturers. In addition, if the name of firm is different from the ISO 13485 certificate, how should I do?
A：If names of firms are the same and the difference is only in Oy and Ltd., as long as the original instructions for equality, reviewers will identify the discretion of leniency. As for the certificate of ISO 13485, it can issue the original letter by the Notified Body to explain the reasons about the differences of company’s name.
Q：When will the draft of measures simplifying the registration of new medical devices inspection be implemented? After implementation, is it available for the cases has been sent to reviewers? Is it acceptable to reduce the clinical data for the products with the same principle but with different ingredients and prescriptions? If there is a similar product listed in the application process, should this case to be converted to general medical devices review?
A：The draft measures：
(1) Due to the need of review with revised guidelines, it should be waiting until the official announcement. The draft of measures simplifying the registration of new medical devices will be announced in mid-June.
(2) The file which has been sent to reviewers before this announcement can use the simplify mode, but still depending the consideration case by case and internal sign-off.
(3) If there are sufficient documents or test data to prove the change of ingredients will not affect the safety and effectiveness of the product, then it meet the definition of similar products, clinical data can be reduced.
(4) If there are similar goods listed in the process of application, you can communicate with the TFDA. After estimating its similar characteristics and risk level of their products are not improved, it can be changed to general medical devices review. If in the case of high-risk products, it still submits clinical data and provides consultation to discuss medical devices.
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