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Whether you are a medical device manufacturer or distributor, our dedicated team is here to help you navigate the complex regulatory landscape and bring your products to market efficiently and compliantly.
Who We Are
With offices in Singapore, Malaysia, Indonesia, the Philippines, Thailand, Vietnam, and Cambodia, our in-house team of local experts provides unrivaled assistance to ensure your products meet all regulatory requirements.
Who We Work With
- Medical Device Manufacturers: From startups to established companies, we assist manufacturers in bringing their innovative medical devices to market.
- IVD Manufacturers: We support in-vitro diagnostic manufacturers in navigating the regulatory landscape to introduce their products to Southeast Asian markets.
Our Services
Regulatory Services
Device Registration
Device Registration
We handle the entire registration process, ensuring your medical devices comply with local regulations.
Authorized Representation
Authorized Representation
We handle the entire registration process, ensuring your medical devices comply with local regulations.
Regulatory Intelligence
Regulatory Intelligence
We handle the entire registration process, ensuring your medical devices comply with local regulations.
Post Market Surveillance
Post Market Surveillance
We handle the entire registration process, ensuring your medical devices comply with local regulations.
Why Choose Us?
Local Expertise
Our team consists of experienced regulatory affairs specialists based in key ASEAN markets.
In-House Team
Unlike other firms, we do not outsource. Our clients benefit from consistent, reliable support from our dedicated employees.
ISO 13485:2016 Certified
We meet the highest standards of the medical device sector, ensuring quality and safety in all our services.
Proven Track Record
We have successfully registered and maintained over 2000 medical devices across various medical device category.
Our Services
Regulatory Services
Contact Us
Fill out our contact form or reach out to us via phone or email. Our team will respond within 1 working day.
Initial Consultation
We will schedule a consultation to understand your needs and discuss how we can assist you.
Customized Plan
Based on your requirements, we will develop a tailored plan to achieve your regulatory and market access goals.
Implementation
Our team will handle all aspects of the regulatory processes, keeping you informed every step of the way, ensuring the products registered in a timely manner.
Contact Us
ANDAMAN MEDICAL PTE LTD (Head Office Singapore)
Tampines Junction Business Center
Level 09-02, 300 Tampines Avenue 5,
Singapore 529653
