FAQ
Medical Devices
All
No. Class Title
  1   Others  

As a general consumer who had difficulty acquiring suitable medical devices in Taiwan for personal medical needs. Is it available to purchase medical devices online from foreign country and import them into Taiwan?

 
  2   Good Manufacturing Practice or Quality System Documentation of a Domestic and Foreign Medical Devices (QSD/GMP)  

Explanatory documents issued by the original manufacturer are required as attachments for QSD document applications. How do I prepare such documents?

 
  3   Good Manufacturing Practice or Quality System Documentation of a Domestic and Foreign Medical Devices (QSD/GMP)  

EIRs issued by a European Union (EU) notified body are required as attachments for a EU simplified QSD application. Which notified bodies of the EU can issue such a document?

 
  4   Good Manufacturing Practice or Quality System Documentation of a Domestic and Foreign Medical Devices (QSD/GMP)  

When submitting a simplified QSD application (US or EU-TCP simplified mode), is it necessary to attach the documents specified in Section 3.7–3.9 of the application form for a QSD Conformity Assessment for the Manufacturer of Imported Medical Devices?

 
  5   Good Manufacturing Practice or Quality System Documentation of a Domestic and Foreign Medical Devices (QSD/GMP)  

What are the documents required for a QSD application?

 
  6   Good Manufacturing Practice or Quality System Documentation of a Domestic and Foreign Medical Devices (QSD/GMP)  

In a QSD application, if the scope of the ISO 13485 certificate is too broad, are there any other alternative documents that can be used as a replacement for an explanatory letter issued by a notified body?

 
  7   Clinical Studies  

In what circumstances will the FDA Medical Device Review Committee request the applicant, who had apply for a product notification with a predicate in Taiwan, to provide the documents about clinical trial reports, theoretical basis and relevant research reports.

 
  8   Clinical Studies  

When applying for registration and market approval for medical devices in Taiwan, which product types require clinical trials to be carried out in Taiwan before they can be reviewed?

 
  9   Manufacture and Free Sale Certificates (FSC)  

What should I do if I am unable to obtain a manufacture and free sale certificate issued by the health authority of the manufacturing country because the product is not listed as a medical device in said country?

 
  10   Manufacture and Free Sale Certificates (FSC)  

For a Mexican manufacturer operating under the Maquiladora program, does the FDA recognize USFDA certificates of manufacture and free sale that issued to such a manufacturer?

 
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