Local Authorised Representative in Cambodia
Local Authorised Representative in Cambodia
Entering Cambodia’s medical device market can be challenging, especially when navigating local regulations from overseas. That’s where Andaman Medical comes in.
As a trusted Local Authorised Representative (LAR) in Cambodia, we offer the local expertise and regulatory support you need to ensure smooth market access and ongoing compliance. We manage the complexities on your behalf, allowing you to focus on delivering your medical innovations to healthcare providers and patients across Cambodia.
Cambodia Authorized Representative for DDF Registration & ASEAN Market Compliance
Looking to enter Cambodia’s medical device market and need clarity on local regulatory expectations? Foreign manufacturers operating without a local subsidiary must appoint a Local Authorised Representative (LAR) to act as their official in-country regulatory contact. The LAR ensures your products meet Cambodia’s Ministry of Health (MoH) requirements and provides support throughout the registration and post-market process.
At Andaman Medical, we offer the local regulatory expertise needed to navigate Cambodia’s evolving approval pathways with confidence. Our team manages product registration, licence coordination, communication with the MoH, post-market surveillance, adverse event reporting, and all additional compliance obligations required to maintain your market presence.
Why Appoint a Local Authorised Representative in Cambodia?
- Meet essential MoH requirements for foreign manufacturers
- Ensure clear, consistent communication with regulatory authorities
- Navigate Cambodia’s registration and approval processes with local insight
- Maintain ongoing compliance through structured post-market and vigilance activities
- Support your long-term presence in a growing and emerging healthcare environment
Streamlined Registration Process
Streamlined Registration Process
A LAR has the local expertise and understanding of regulatory procedures, helping to navigate complex documentation and submission requirements. This streamlines the registration process, reducing the risk of delays and rejections.
Regulatory Compliance
Regulatory Compliance
A LAR ensures that all requirements set by Cambodia’s Ministry of Health are met, helping companies stay compliant with current regulations and avoid penalties or product recalls.
Efficient Communication with Authorities
Efficient Communication with Authorities
LARs act as a direct communication link between the company and Cambodian regulatory bodies, effectively addressing any questions, requests for additional information, or changes in requirements.
Up-to-Date Knowledge of Regulatory Changes
Up-to-Date Knowledge of Regulatory Changes
LARs keep companies informed about the latest regulatory updates and policy changes in Cambodia, ensuring ongoing compliance and helping to adapt strategies quickly when needed.
Faster Market Access
Faster Market Access
With the local knowledge and established relationships with regulators, a LAR can expedite the approval process, allowing faster entry into the Cambodian market and enabling companies to start selling their medical devices sooner.
Local Representation for Product Issues
Local Representation for Product Issues
A LAR is responsible for handling post-market surveillance, adverse event reporting, and product recalls, providing a local point of contact for regulatory authorities, which is crucial for ongoing market access.
Requirements for a Marketing Authorization Holder or Local Authorised Representative (LAR) in Cambodia
Local Licence
The authorized representative consultant in Cambodia must be a local licensed pharmaceutical company which has a Cambodian pharmacist name as the representative.
Multiple Marketing Authorization Holders
- Only one registrant can register a device at a time.
- Foreign manufacturers must issue a letter of authorisation (LOA) to appoint a registrant, who can be changed during renewal.
- Although foreign manufacturers can be license holders, the registration dossier must be submitted by a local licensed importer employing a Cambodian pharmacist.
- The foreign manufacturer can appoint either themselves, their local distributor, or a local authorized representative in Cambodia as the license holder or marketing authorization holder.
Navigating the role of a Local Authorised Representative in Cambodia can be complex, but Andaman Medical is here to simplify the process and ensure you remain fully compliant. Connect with our experts today and take the first step toward seamless representation!
Why Choose Andaman Medical?
