December 17, 2018

On December 7th 2018, TFDA has formally announced that Japanese manufacturers may take a QSD simplified route of application. With the well-coordinated evaluation protocols of PMDA and TFDA, the approval of the simplified route has been granted with an aim of increasing efficiency, hereby decreasing workload of Japanese manufacturers.

The Japanese manufacturers shall meet the following condition:

i) Manufacturers must have an ISO 13485 license, duly issued by accredited 3rd party Notified Bodies enumerated below:

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ii) Audit reports shall be issued by PMDA or any of the above Notified Bodies.

As of the moment, TFDA offers several simplified routes of QSD application. However, each route also requires different documents to be included in the submission dossier, depending upon the product’s country of origin. In order to assist our clients in understanding each document required for every route, Qualtech has provided a brief summary as found in the below table.

Table 2. Documentations required for four (4) evaluation routes, namely: (a) Full (b) USA factory (c) EU factory & (d) JP factory.

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V: necessary       O: in case