Medical Device Registration

All medical devices, whether manufactured domestically or imported, must be registered with local regulatory authorities before they can be placed on the market, with some exceptions and exemptions.

Singapore, Malaysia, Indonesia, the Philippines, Thailand, and Vietnam are signatories to the ASEAN Medical Device Directive (AMDD), harmonizing medical device registration in Southeast Asia. The AMDD introduced the Common Submission Dossier Template (CSDT) for a standardized submission process; each country still has unique requirements for medical device registration.

Medical Device Registration in Southeast Asia

The medical device registration processes, product classifications, and conditions for product groupings differ widely between countries. Registration fees and timelines vary from 5 to 280 days, along with the validity periods of market clearance certificates.

Some countries allow product renewals, change notifications, and license transfers, while others do not. Therefore, it’s important to work with a distributor or authorized representative who understands the intricacies of medical device registration in Southeast Asia, ensuring long-term compliance and market availability.

Why Andaman Medical Is Your Ideal Medical Device (MD) Compliance Consultancy

We offer comprehensive medical device registration consultancy in Southeast Asia, ensuring your products comply with all local regulations. As your local representative, Andaman Medical handles the preparation, submission, and management of your medical device registrations, offering you flexibility in market access and distribution.

With eight offices across Southeast Asia, our team works directly with local authorities to register your products through standard, abridged, or special access routes. We also manage registration renewals, change notifications, and license transfers.

Standard product registration

Abridged product registration

Special access product registration

Renewal of product registration

Change notification

Product license transfer

Liaison with local government agencies on regulatory issues

Regulatory monitoring for changes affecting your product

License holding

Adverse event reporting and management

Product alert and recall tracking

Complaint handling

Regulatory intelligence reports for market access and regulatory insights

Online regulatory training

Importation

Distribution

Why Choose Andaman Medical?

Get Expert Help Today

Contact us today to discuss how Andaman Medical can be your trusted partner for Medical Device Registration in Southeast Asia. Our experienced team is ready to help you achieve your commercial goals in this dynamic, fast-growing region.
Scroll to Top

Contact Us


Stay Ahead in Southeast Asia's Medical Device Market!

Subscribe to our Newsletter

Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!