Nord Pacific Medical

Nord Pacific Medical, your regulatory affairs partner for the East Asian market.

Building on Andaman Medical’s legacy, we provide comprehensive regulatory support for medical devices and IVDs. Our services include regulatory and market access services such as device registration, local authorized representative services, post-market surveillance, regulatory intelligence, and importation. We ensure a smooth East Asian market entry, letting you focus on innovation.

Full Control With Seamless Distributor Switching

QMS Compliance
(ISO 13485 Certified)

One-stop Access to 11 Asian Countries

A dedicated compliance team. All yours.

As Asia’s leading provider of regulatory outsourcing for medical devices, we provide you with a dedicated team of in-house regulatory affairs experts. With the right partner, you can get the best registration and market access route for your Medical Devices and IVDs, ensuring it reaches the right customers on time.

Our services

Medical Device Registration

Local Regulatory Compliance
Complete Dossier Preparation and Submission
Labelling and Review
On-site Follow-up
Timely Approval

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Local Authorised Representative

Local Business Presence
Full Control on Registration License
Flexibility Working with Different Distributor (Switching Without Hassle)
Post-market Surveillance
Prompt Updates on Regulations

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Post Market Surveillance

As Required by Local Regulation Requirement (Authorised Representative to be the Importer)
Importation Compliance
Customs Clearance
Record-keeping of the Importation Documents

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Regulatory Intelligence

Covering All Regulatory Affairs Topics
Document Compliance Screening
Gap Analysis

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Where are we located?

Andaman Medical currently operates eight offices across seven countries in South-East Asia, with in-house specialists in regulatory affairs and logistics. As part of Andaman’s expansion, Nord Pacific Medical offices covers East Asia to its network. This comprehensive coverage allows you to have direct access to local and ensures a hassle-free management of all your regulatory affairs.

Why choose us?

Experienced in-house Teams Across The Region

Full Control With Seamless Distributor Switching

Singular Point of Contact for Registration

QMS Compliance
(ISO 13485 Certified)

Comprehensive Service Beyond Language Barriers

One-stop Access to The Region

Latest Insights

Stay informed of the regulatory changes and relevant country information that affect market access for your medical device and IVD:

Press Release Updates

Nord Pacific Medical to bring regulatory and market access services to East Asia

Singapore • 1 April 2024

Nord Pacific Medical has launched across the East Asian market, building upon sister company Andaman Medical’s legacy by offering across-the-board regulatory and market access support for manufacturers and distributors of medical devices and in vitro diagnostics (IVD).

Welcome to Nord Pacific Medical!

We are thrilled to announce that we are now open for business. Discover our exciting new venture and stay informed about our progress through our press releases and updates.

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Get compliance where and when you need it.

Our Contact Information