Medical Device Registration
All medical devices, whether manufactured domestically or imported, must be registered with local national regulatory authorities responsible for medical devices before they can be placed on the market – albeit certain exceptions and exemptions from product registration do exist.
Singapore, Malaysia, Indonesia, the Philippines, Thailand and Vietnam are all signatories to the ASEAN Medical Device Directive (AMDD) which was created to harmonize medical device legislation throughout Southeast Asia. With the arrival of the AMDD, came the welcome introduction of the Common Submission Dossier Template (CSDT). While there are some similarities across the countries, such as the CSDT, each country has its own registration process and requirements.
Medical Device Registration in Singapore, Malaysia, Indonesia, the Philippines, Thailand and Vietnam
Not only do the medical device registration processes differ widely from country to country, but there are also wide differences in the classification of products, and whether groupings of products are allowed and under which conditions.
Registration fees and timelines to achieve marketing authorization from the date of submission vary widely from 5 to 280 days. As well as the length of validity of the final market clearance certificates.
Product renewals, change notifications and license transfers are allowed in some countries but not in others. It is therefore vital to work with a distributor or authorized representative who fully understands all the intricacies of each market, not only for the initial registration but over the long term to ensure your product remains fully compliant and available in the market.
How Andaman Medical can help you with your medical device registration:
As your in-country representative, Andaman Medical prepares, submits and manages your medical device registrations giving you independence and flexibility over your market access and distribution strategy.
With six local offices in the major Southeast Asian markets, our local, in-house staff liaise with the local medical device authorities to register your products, whether using standard, abridged or special access routes. We also carry out registration renewals, change notification and license transfers where possible.
Our registration services include:
- Standard product registration
- Abridged product registration
- Special access product registration
- Renewal of product registration
- Change notification
- Product license transfer
- Liaison with the local authorized government agency on all regulatory issues relating to your medical device including amendment and change notifications
- Regulatory monitoring to alert you to any changes or new regulation applicable to your product
- License holding
- Adverse event reporting and management
- Product alert and recall tracking
- Complaint handling