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Medical Device Regulatory 2018-01-05T16:39:19+00:00

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.

Medical Device Regulatory – FAQ

ACCSQ-MDPWG* aims to standardize the regulatory framework for regulating medical device among ASEAN member states, with a set of principles described in in the ASEAN Medical Device Directive (AMDD).

Key Features In AMDD

  • Establishment licensing for Manufacturers, Local Representatives, Importers and Distributors
  • Product classification & registration
  • Adverse event reporting
  • Post-Market Surveillance

*ASEAN Consultative Committee on Standards and Quality-Medical Device Product Working Group

Every country in ASEAN has its own specificities, some have basic regulatory controls involving a notification rather than a registration and others have a comprehensive registration process (ie: Malaysia and Singapore). Your appointed Local Authorized Representative will take care of your product registration in the targeted country. Product registration is undertaken in parallel with establishment licensing and a product can only be registered when the proper license is granted to the applicant.

Two Main Elements Of Product Registration

  • Common Submission Dossier Template (CSDT)
  • Declaration of Conformity (DoC)
Your registration costs will be dependent on the targeted country. Contact us for a comprehensive plan that is based on your intended products.