Q：If people find that when defective medical devices, how should they do?
A：
(1) According to the Pharmaceutical Affairs Law Article 13 about the medical device, it refers to diagnosis, treatment, mitigation or prevention of human disease directly.
Or it is enough to affect the structure of human body and the function of the instruments, apparatus, appliances, and its attachments, accessories and parts.
(2) If people find bad situations while using the medical devices, such as: there is hair and other contaminants in the sterile package; contents and packaging specifications cannot match together; unused product that is damaged……etc. You can access to “National Medical Product Defect Reporting System” (http://recall.fda.gov.tw/) for online notification, or download the "Medical Devices Defect Reporting Statements" by mail, fax or e-mail notification.
(3) If defective medical devices caused serious adverse reactions, it should be reported to the “Taiwan National Adverse Drug Reactions Reporting Center” (https://adr.fda.gov.tw/).
(4) When you confirm the non-medical devices, you can report to the website called “Bureau of Standards, Metrology & Inspection” with merchandise accident recall website. (http://safety.bsmi.gov.tw/wSite/np?ctNode=3572&mp=65).
Q：How to determine whether the product is a new medical equipment or not?
A：It is represented that the new medical equipment has the new principles, new structures, new materials, or new material to combine for manufacturing. Its safety or efficacy of medical has not been medically proven (ie, the TFDA has not approved similar goods), or other central competent health authority to review and identify that the equipment should be categorized to new medical equipment or not. If you can cite similar products which have been approved by the TFDA at the time of inspection and registration, and it won’t be reviewed by new medical equipment. It refers to the TFDA noticed on 18 August 1999 granted the Department of Food No. 0991608423 "Medical Equipment Similar Product Determination Process and Application Instructions." to judge the similar product.
Q：Which kind of product is required to conduct domestic clinical trials?
A：When the application has been announced by TFDA inspection and registration, the item should conduct clinical trials in the country. It refers to Attachment III of the content of medical equipment management. As for other application for registration of medical equipment to conduct clinical trials in the country or not, manufacturers should be assessed (if any consideration of ethnic differences, etc.) on the product features whether there are clinical trials in domestic demand or not. When it is necessary, you can base on the notice number “0920332729” announced by TFDA in December 2, 2003, and support document letter of inquiry to TFDA.
Q：According to "Guidelines for Registration of Medical Devices in Taiwan", applying registration of medical devices shall attach pre-clinical trial and testing and original manufacturer quality control test specifications and methods, original test records, and test results report. What’s the detail about it?
A：The test data contents should include:
(1) Method: The method is based on the officially sanctioned standards or original manufacturer's methods. The method based on officially sanctioned standards should include standard names, and the method based on original manufacturer should set out the complete test procedure (SOP, test method, procedure, and protocol).
(2) Items: Test name.
(3) Specifications: Qualified or acceptable range (criteria, specification).
(4) Original record: Test value.
(5) Test results report: Test result whether is a pass or fail.
Q：Our company's product is diagnosed as X-ray machine. According to the "Guidelines for Registration of Medical Devices in Taiwan," applying registration of medical devices shall attach radiation safety information for equipment generating ionizing radiation. What’s the detail about it?
A：If there is ionizing radiation equipment, it shall attach radiation safety information which is ordered by Atomic Energy Commission (http://www.aec.gov.tw). The information should be included: Radiation safety review of the project and its corresponding radiation safety test data (i.e. IEC 60601-1-3), reviewed by TFDA forward to Atomic Energy Commission.
Telephone numbers and address of Atomic Energy Commission:
02-22322295 Mr. Lee, 02-22322196 Mr. Liu, 02-22322194 Mr. Tsai
No.80, Sec. 1, Chenggong Rd., Yonghe Dist., New Taipei City 234, Taiwan (R.O.C.)
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