Regulatory Compliance
A LAR ensures that all requirements set by Thailand’s Food and Drug Administration (Thai FDA) are met, helping companies stay compliant with current regulations and avoid penalties or product recalls.
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.
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.
Faster Market Access
With the local knowledge and established relationships with regulators, a LAR can expedite the approval process, allowing faster entry into Singapore market and enabling companies to start selling their medical devices sooner.
Up-to-Date Knowledge of Regulatory Changes
LARs keep companies informed about the latest regulatory updates and policy changes in Singapore, ensuring ongoing compliance and helping to adapt strategies quickly when needed.
Efficient Communication with Authorities
LARs act as a direct communication link between the company and Singapore’s regulatory bodies, effectively addressing any questions, requests for additional information, or changes in requirements.
Regulatory Compliance
A LAR ensures that all requirements set by Singapore’s Ministry of Health are met, helping companies stay compliant with current regulations and avoid penalties or product recalls.
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.
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.
Faster Market Access
With the local knowledge and established relationships with regulators, a LAR can expedite the approval process, allowing faster entry into the Philippines market and enabling companies to start selling their medical devices sooner.
Up-to-Date Knowledge of Regulatory Changes
LARs keep companies informed about the latest regulatory updates and policy changes in the Philippines , ensuring ongoing compliance and helping to adapt strategies quickly when needed.
Efficient Communication with Authorities
LARs act as a direct communication link between the company and Philippines regulatory bodies, effectively addressing any questions, requests for additional information, or changes in requirements.
Regulatory Compliance
A LAR ensures that all requirements set by FDA are met, helping companies stay compliant with current regulations and avoid penalties or product recalls.
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.
Local Presence
Appointing a LAR gives manufacturers a local presence and expert knowledge of Malaysia’s regulatory landscape without needing to set up a subsidiary.
Post-Market Activities
The LAR can facilitate the import process and manage relationships with local distributors, issuing Letters of Authorisation to them as needed.
Import and Distribution
The LAR can facilitate the import process and manage relationships with local distributors, issuing Letters of Authorisation to them as needed.
Regulatory Compliance
Only a local representative can submit medical device registration applications through the MedCast online system.
Product Registration
Only a local representative can submit medical device registration applications through the MedCast online system.
Liaison with Regulatory Authorities
The LAR acts as the primary point of contact with the MDA, managing all regulatory communications and submissions on behalf of the manufacturer.
Regulatory Requirement
Foreign manufacturers without a registered office in Malaysia are legally required to appoint a LAR under the Medical Device Act 2012, enforced by the Malaysian Medical Device Authority (MDA).
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.
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.
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.
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.
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.
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.
Long-Term Growth
With the increasing demand for quality healthcare services and diagnostic solutions, the Philippines offers significant opportunities for long-term growth. Registering your medical devices ensures you are well-positioned to capitalise on future market developments and expand your presence in this dynamic region.
Credibility and Trust
Obtaining FDA approval for your medical devices enhances your credibility and trustworthiness in the eyes of healthcare professionals, patients, and business partners. It demonstrates your commitment to providing safe and effective diagnostic tools, thereby boosting your reputation and brand value.
Market Access
The Philippines is one of the fastest-growing markets in Southeast Asia2 with a rapidly expanding healthcare sector. Registering your medical device allows you to tap into this burgeoning market, providing access to a large and diverse patient population in need of advanced diagnostic solutions.
