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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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Andaman Medical is a regulatory affairs and market access consultancy specializing in the registration, authorized representation and importation of medical devices and IVDs in Southeast Asia. As the in-country representative, we prepare, submit and manage device registrations giving you independence and flexibility over your market access and distribution strategy. And we ensure your medical devices obtain customs clearance and are distributed to your end customer.
We provide you 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 have grown 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.
Tampines Junction Business Center
Level 09-02, 300 Tampines Avenue 5
Phone: +60 4566 0200