Our Services
Independent Authorized Representative
Malaysian law requires foreign medical device manufacturers to appoint a local authorized representative. Global Rep provides independent services that ensure regulatory compliance, protect your business interests, and strengthen supply chain integrity. Partnering with us eliminates conflicts of interest, giving you full control over operations and the freedom to choose your preferred importers and distributors.
Our Core Responsibilities and Deliverables
Official Regulatory Contact
Acts as your official contact point with the Medical Device Authority.
Product Registration
License Verification
Review establishment licenses to verify that potential importers and distributors are duly authorized to carry out the required supply chain functions under Malaysian regulations.
Importer and Distributor Appointment
Market Expansion Support
Facilitate the introduction of qualified importers and distributors to strengthen and broaden your market presence in Malaysia.
Inquiry Management
Post‑Market Surveillance
Conduct ongoing surveillance to ensure the safety and effectiveness of products in the Malaysian market. We collect, communicate with stakeholders in the supply chain, and address post‑market safety and effectiveness concerns, and report them to the Medical Device Authority in accordance with regulatory requirements.
Benefits Of Having An Independent Local Authorized Representative
Your Strategic Regulatory Partner
An independent Authorized Representative acts as your official product registration holder, providing dedicated regulatory expertise and streamlined oversight.
Neutral and Flexible Market Access
Our impartiality allows you to work with multiple or change distributors freely, without risking your registration or compliance.
Dedicated Expertise & Confidentiality
We focus solely on managing registrations, licensing, and surveillance with precision, while safeguarding your sensitive technical data and intellectual property.
Why Choose Global Rep as Your Malaysia LAR?
Proven International Experience
We successfully partner with global businesses, delivering projects to the highest standard through clear communication and precise execution.
Ethical & Transparent Partnerships
We build trustworthy relationships based on integrity, transparency, and open communication.
Neutral & Independent Representation
We operate without ties to any local partner, enabling you to appoint or change distributors freely without risking your market approvals.
Regulatory Expertise
Our deep expertise covers the full regulatory lifecycle management, from licensing and registration to compliance controls. This ensures smooth and compliant market entry, as well as long term compliance.
Confidentiality & IP Protection
We strictly protect your sensitive product data and intellectual property through controlled access and confidentiality protocols.
Popular Questions
An independent authorized representative is appointed by foreign medical device manufacturers to represent them in Malaysia. With no commercial ties to importers or distributors, their role focuses solely on regulatory affairs: serving as the official contact with the Medical Device Authority, registering products, appointing importers and distributors, sharing market inquiries, and managing post-market surveillance. They also safeguard proprietary product information, ensuring it is used only for registration purposes
Foreign medical device manufacturers who want to market their medical devices in Malaysia.
Beyond reputation and market presence, foreign medical device manufacturers must verify an establishment’s licensing status. Under Malaysian law, establishments must hold valid licenses for roles such as authorized representative, importer, or distributor, and only those properly licensed may be appointed.
Yes, a foreign medical device manufacturer may appoint multiple distributors as authorized representatives for the same product. However, this requires paying registration fees for each distributor, including any changes, and distributors may be reluctant to bear the costs due to competitive dynamics—making the arrangement commercially unattractive unless the market is clearly segmented.