Local Authorised Representative in Malaysia
Local Authorised Representative in Malaysia
Entering Malaysia’s medical device market can be a complex process, especially if you’re navigating it from abroad. That’s where Andaman Medical comes in.
As a trusted Local Authorised Representative (LAR) in Malaysia since 2014, we provide the local expertise and hands-on support you need to ensure seamless market access and compliance. We take care of the complexities, so you can focus on delivering your medical innovations to the people who need them most.
Your Malaysia Medical Device Authorized Representative for MDA Compliance & Market Access
Expanding into Malaysia and need reliable support to meet local regulatory requirements? Foreign manufacturers without a local subsidiary must appoint a Local Authorized Representative (LAR) to serve as the official regulatory contact. The LAR ensures your medical device complies with Malaysia’s Medical Device Act and all requirements set by the Medical Device Authority (MDA).
At Andaman Medical, we provide the in-country expertise you need to navigate Malaysia’s regulatory landscape with confidence. Since 2014, we have supported manufacturers by managing product registration, licence applications, regulatory communications, post-market surveillance, adverse event reporting, and other compliance obligations essential for smooth market entry.
Why Appoint a Local Authorised Representative in Malaysia?
- Fulfil mandatory MDA requirements for foreign manufacturers
- Ensure accurate, timely communication with national regulatory authorities
- Navigate Malaysia’s submission and approval processes with expert guidance
- Maintain long-term compliance through coordinated post-market and vigilance activities
- Build a strong foothold in one of Southeast Asia’s most advanced and well-regulated medical device markets
Regulatory Requirement
Regulatory Requirement
Foreign manufacturers without a registered office in Malaysia must appoint a Local Authorized Representative (LAR) under the Medical Device Act 2012, enforced by the MDA. We act as your LAR, ensuring compliance and providing a reliable local presence.
Liaison with Regulatory Authorities
Liaison with Regulatory Authorities
The LAR serves as the main point of contact with the MDA, managing regulatory communications and submissions for manufacturers. We streamline these processes by handling all interactions with the MDA, saving you time and ensuring smooth regulatory approvals.
Product Registration
Product Registration
Medical device registration applications can only be submitted through the MedCast online system by a local representative. We handle the entire registration process, ensuring accurate submissions and timely market approval.
Regulatory Compliance
Regulatory Compliance
The LAR ensures that manufacturers comply with Malaysian medical device regulations, including conformity assessments, ISO 13485 quality management systems, labeling requirements, and post-market surveillance. We provide end-to-end support to ensure your devices meet these regulatory standards and remain compliant.
Import and Distribution
Import and Distribution
The LAR facilitates the import process and manages relationships with local distributors, including issuing Letters of Authorization as required. We streamline your import operations and coordinate with distributors to ensure smooth and efficient market entry.
Post-Market Activities
Post-Market Activities
The LAR oversees essential post-approval tasks, such as adverse event reporting, product recalls, change notifications, and license renewals. We handle all post-market requirements, helping you maintain compliance and ensuring the continued availability of your device.
Local Presence
Local Presence
Appointing a LAR provides manufacturers with a local presence and expert understanding of Malaysia’s regulatory landscape without needing to establish a subsidiary. We act as your trusted local representative, offering deep regulatory knowledge and dedicated support for your success in the market.
Our Local Authorised Representative Services in Malaysia
Representation
Act as your company’s representative in all dealings with the Ministry of Health for medical devices and in-vitro diagnostics.
Authority
Manage all obligations under the Malaysian medical device regulatory system.
Experience
Provide expert support based on years of experience representing manufacturers and distributors.
Product Registration
Register your medical devices with the MDA.
Change Notifications
Submit change notifications as needed.
Licence Transfers
Handle the transfer of product licences.
Post-Market Surveillance
Ensure compliance with post-market surveillance requirements, including Mandatory Problem Reporting and Complaint Handling.
What You Need to Know About Having a Local Authorised Representative in Malaysia
To qualify as a Local Authorised Representative, a company must meet specific criteria outlined by the MDA:
Why Choose Andaman Medical?
