Andaman Medical is a regulatory affairs and market access consultancy specializing in the registration, authorized representation, importation and master distribution of medical devices and in-vitro diagnostics (IVDs) in Southeast Asia.
As the in-country representative, we prepare, submit and manage device registrations giving our clients independence and flexibility over their market access and distribution strategy. And we ensure medical devices obtain customs clearance and are distributed to the end customer.
We provide our clients with the ongoing regulatory intelligence and insight on how to navigate the complex regulatory arena particularly at this time of increased post-market surveillance (PMS) and constantly updated compliance requirements.
We also design, implement and audit Quality Management Systems for Good Distribution Practice for Medical Devices that is mandatory in some ASEAN countries.
Founded in 2013, we decided to focus exclusively on medical devices Southeast Asia and have grown over the last seven years to open seven offices in Singapore, Malaysia, Indonesia, Philippines, Vietnam, Thailand and Vietnam (Ho Chi Minh City and Hanoi offices), registering, maintaining and importing 1000+ medical devices of all classes and all therapeutic areas from ophthalmics to orthopedics, from cardiovascular to CNS, from diabetes to diagnostics and much, much more. We work with 100s of companies from startups to SMEs to Blue Chips assisting them to grow their businesses swiftly.