Indonesia, Malaysia, the Philippines, and Thailand

For expert assistance with medical device registration in Asia, rely on Pacific Bridge Medical's (PBM's) medical device consultants.

The medical device markets in Indonesia, Malaysia, the Philippines, and Thailand are about $1.2 billion in total. Medical device registration in these countries varies.

While product registration is voluntary in Malaysia, in the other countries, a modest amount of paperwork needs to be submitted. If your medical device has Western approval, things will often be easier.

Understanding the Common Submission Dossier Template

The Association of Southeast Asian Nations (ASEAN) is implementing a plan to harmonize medical device regulations called the ASEAN Medical Device Directive (AMDD).

The AMDD lays out basic requirements for medical device safety and performance, the medical device classification system, a Common Submission Dossier Template for medical devices (CSDT), and an ASEAN-wide postmarketing alert system. 

The CSDT sets out what data will be required in the single dossier usable for device registration in all ASEAN countries. The CSDT format will be used in all ten ASEAN countries by 2015, meaning that a dossier accepted by any ASEAN regulatory body can also be accepted in the same format by all other ASEAN regulatory authorities.

The other major document required for medical device approval is the Declaration of Conformity, which demonstrates the medical device's compliance with the ASEAN Essential Principles of Safety and Performance.