Medical Device Regulatory Services for Association of Southeast Asian Nations (ASEAN) Countries

Navigate Association of Southeast Asian Nations (ASEAN) Medical Device Regulatory Services with Freyr's Expertise!

Medical Device Regulatory Services for Association of Southeast Asian Nations (ASEAN) Countries Overview

The Association of Southeast Asian Nations (ASEAN) is a regional alliance of ten (10) countries: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam. With a population exceeding 650 million and a fast-evolving healthcare market, this region offers a vibrant opportunity for manufacturers of medical devices, In-vitro Diagnostic (IVD) devices, combination devices, and Software as a Medical Device (SaMD).

Navigating the Regulatory framework in the ASEAN region can be challenging due to each country’s unique set of regulations, guidelines, and requirements. To effectively manage this complex needs, medical device companies would require specialized expertise and support.

Freyr, with an exclusive delivery center in India and a strong presence across the ASEAN region through local affiliates, provides comprehensive Regulatory support for medical devices. We streamline the process of obtaining market authorizations and approvals, making it easier to introduce and sell your devices in this burgeoning market.

Unlock your potential in the ASEAN market with our comprehensive Regulatory services. Reach out to Freyr's specialists today to discover how we can help you achieve your goals.

Freyr Association of Southeast Asian (ASEAN) Competencies

  •  
    Product Classification and Registration Services
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    Quality Management System (QMS) Compliance Strategy
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    Local Representation Services
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    Health Agency Liaising & Support
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    Gap Analysis of Technical Documents & Quality Systems
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    Regulatory Support for Product Development Documents such as, Design History Files (DHFs)
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    Regulatory Support for Technical File Compilation
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    Regulatory and Market Intelligence Support
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    Document and Labeling Translation Support

Frequently Asked Questions (FAQs)

The ASEAN Medical Device Directive (AMDD) is a framework established to harmonize medical device regulations across the ASEAN Member States, facilitating easier market access and Regulatory compliance.

No, registration must be obtained separately for each ASEAN country, where the device will be marketed, although the harmonized approach of the AMDD aims to simplify and align the requirements across the Member States.

Some ASEAN countries may accept Regulatory approvals from other recognized jurisdictions (e.g., CE marking for the EU, the FDA approval for the US) to expedite their own registration process, depending on local regulations and equivalency assessments.

Book a meeting with our Regulatory experts

Medical Device Regulatory Consulting – Proven Expertise

120

+

Countries
1900

+

Global Customers
2200

+

In-house Regulatory Experts
850

+

In-country Regulatory Affiliates
8
Global Delivery Hubs

Why Freyr?

  • Our experts guide you through the registration process, ensuring your device classification, technical documentation, and labeling meet all the requirements.
  • We navigate the nuances of individual ASEAN Member State regulations, ensuring compliance in each target market.
  • Our team offers strategic advice on Regulatory requirements, risk management plans, and Post-market Surveillance (PMS).
  • We can act as your Authorized Representative (AR) in ASEAN countries, simplifying communication with the Regulatory authorities.
  • We optimize your Regulatory strategy to avoid unnecessary costs and delays.