Regulatory affairs and market access for medical devices & IVDs across Southeast Asia since 2013

From registration to ongoing authorized representation for post-market surveillance and compliance; from importation including customs clearance to distribution of your products, we promise to get your medical device to your customer.

We focus exclusively on medical devices and IVDs across Southeast Asia, and with our own in-house team of locally employed regulatory affairs specialists, trained and experienced in medical devices, who better to ensure you receive unrivalled assistance as to the best registration and market access route for your medical device.  You can be sure we don’t outsource.

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