Medical device and IVD regulatory requirements in Southeast Asia
Let Andaman Medical support you with your medical device regulatory requirements in the ASEAN region
Our medical device regulatory services include both pre-market and post-market activities, ranging from the compliance, publishing, submission and update of Medical Devices Regulatory files to Southeast Asia authorities (CSDT, design dossiers and more). Our goal is to provide the professionalism that you expect in a partner and to get the results you need in the most efficient and cost-effective manner.
We customize our services to your company’s culture and needs.
Medical Device Regulations In ASEAN
As a trusted partner based in ASEAN, Andaman Medical consultants continuously strive to deliver to our clients an immediate effect on their bottom line and allow them to stay focused on their core competencies.
ASEAN consists of 10 member countries: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam
- ASEAN Population: 620 million
- ASEAN combined GDP: $2.3 trillion
- ASEAN Medical Device Market Value in 2012: $4 billion
- ASEAN Medical Device Market Value estimated for 2017: $8 billion
Know Your Level Of Risk At The Country Level
Regulations and requirements vary by country, level of risk, specific product claims and intended use. Depending on the classification of your medical device, there are a variety of submissions that may be required by medical device regulatory agencies.
Andaman Medical offers a unique “one-stop service” approach, supporting medical device manufacturers in achieving compliance with regulatory requirements. Our team of regulatory experts can guide you through every step of the submission process.
We have the in-house expertise to support you in preparing submission files which comply to specific local regulations. We will provide an efficient service to address your submission and compliance requirements for the medical device industry.