Dossier for new registration of medical device in group I:
– The legalized Free Sale Certificate (FSC) (valid at the time of submission).
– The legalized Letter of Authorization (valid at the time of submission).
– The ISO 13485 or ISO 9001 quality systems certification (valid at the time of submission).
– Certificate of Warranty Eligibility, except for the device is disposable or having data proved that the product does not have warranty service.
– Declaration of Conformity or Product Specification.
– Technical data describing the functions and technical parameters of medical device.
– Insert leaflet and artwork of this product circulating in original country.
Dossier for new registration of medical device in group IIa, IIb, III:
– The legalized Free Sale Certificate (FSC) (valid at the time of submission)
– The legalized Letter of Authorization (valid at the time of submission).
– The ISO 13485 or ISO 9001 quality systems certification (valid at the time of submission)
– Certificate of Warranty Eligibility, except for the device is disposable or having data proved that the product does not have warranty service.
– Technical data describing the functions and technical parameters of medical device
– Common Submission Dossier following ASEAN guideline about Medical Device (start applying from 01/07/2020)
– Insert leaflet and artwork of this product circulating in original country.
Besides the above documents, medical devices group IIb, III also need to provide further other documents:
– Regarding medical device group IIb, III having invasion into human body: Protocol of Clinical trial data and results of clinical trials, except for:
+ The medical device which has been circulated and issued FSC by one of following countries: Member countries in EU, Japan, Canada, Australia (TGA), USA (FDA).
+ The medical device was already issued registration number before valid time of this Circular.
+ Other cases prescribed by The Minister of Health
Note: The medical device will be evaluated and issued registration number faster if it was already circulated in at least 2 of following countries: Japan, Canada, Australia, USA, member countries in EU.