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.
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.
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.
Indonesia
Indonesia
- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
Malaysia
Malaysia
- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
Vietnam
Vietnam
- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
Thailand
Thailand
- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
Philippines
Philippines
- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
Singapore
Singapore
- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
Cambodia
Cambodia
- IVDs regulated by Ministry of Health as medical devices
- 4 risk classes (A-D) aligned with ASEAN MDD
- All IVDs require registration; some additional requirements for HIV and COVID tests
- MoH total review timeline: 45-80 working days based on risk class
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.
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.
Our registration services include
Our registration services include
- Standard product registration
- Abridged product registration
- Special access product registration
- Renewal of product registration
- Change notification
- Product license transfer
Our authorized representative services include
Our authorized representative services include
- 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
Additional support services
Additional support services
- Regulatory intelligence reports for market access and regulatory insights
- Online regulatory training
- Importation
- Distribution
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?
