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.

What we do

Regulatory services

1000 medical device registrations across six countries; we promise ongoing compliance of your product

As your independent license holder and authorized representative , we will register your medical device, obtain relevant product licenses, and ensure ongoing post-market compliance of your product.

If you’d like to better understand the local regulations applicable to your products or the pathway to market you can request a customized regulatory intelligence report.

You can safely rely on our dedicated team who have registered and currently maintain 1000+ medical devices of all classes and all therapeutic areas from ophthalmics to orthopaedics, cardiovascular to CNS, diabetes to diagnostics and much more. This means you can concentrate on developing and bringing medical devices to market that improve the health and quality of life for millions.

And you can rest reassured you will receive the best quality and service from Andaman Medical as we are ISO 13485:2016 certified. Like our clients, we meet the highest standards of the medical device sector, demonstrating our commitment to the quality and safety of the medical devices we register and represent throughout Southeast Asia.

Market access services

Open up new distribution channels as you retain independent control of your medical device; we promise you access to new markets with greater ease and flexibility

As your principal importer, we work with your transporter, customs brokers and the relevant local authorities, to make sure your product gets safely and legally into the country. We don’t simply advise our clients on what to do or which documents to submit, we actually do it, making it simpler for you.

As your master distributor you are free to nominate as many distributors and sales partners as possible giving you real flexibility in your distribution strategy.  This means you can adapt quickly to changes in the market by adding new distributors, increase transfer pricing as well as ensuring rigorous quality and compliance controls continue post-market.

Countries we cover

We focus exclusively on Southeast Asia and have local offices in each of the seven major ASEAN markets:

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