Medical Device

Overview ：Any medical devices exported to ASEAN will need to follow ASEAN Medical Device Directive and register with the counterpart authority by a local professional license holder.

Business Challenges ：if your products are belongs to the following categories:(a) diagnosis, prevention, monitoring, treatment or alleviation of disease; (b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury; (c) investigation, replacement, modification, or support of the anatomy or of a physiological process;(d) supporting or sustaining life;(e) control of conception;(f) disinfection of medical devices; and providing information for medical or diagnostic purposes by means of invitro examination of specimens derived from the human body;….

Our service ：
(1) License holding assignment
(2) gap analysis
(3) document amending or submission
(4) governmental review
(5) rejecting, amending, communicating with officers till registration

How to start ：Please send us the picture of the product.

Why SCG ：We have reliable local partners with plenty experience.