Local Authorised Representative in the Philippines
Local Authorised Representative in the Philippines
Entering the Philippines’ medical device market can be challenging, especially when managing local regulations from abroad. That’s where Andaman Medical comes in.
As a trusted Local Authorised Representative (LAR) in the Philippines, we offer the local knowledge and regulatory support you need to secure smooth market entry and maintain ongoing compliance. We manage the complexities on your behalf, so you can concentrate on delivering your medical innovations to healthcare providers and patients throughout the Philippines.
Philippines FDA Local Authorized Representative for Medical Device Registration & Approvals
Planning to enter the Philippine medical device market and need guidance on local regulatory requirements? Foreign manufacturers without a local subsidiary must appoint a Local Authorised Representative (LAR) to serve as their official in-country regulatory contact. The LAR ensures compliance with Philippine FDA regulations and supports your pathway from initial device registration through all post-market responsibilities.
At Andaman Medical, we provide the regulatory expertise needed to navigate the Philippines’ approval processes with confidence. Our team manages product registration, licence applications, communication with the Philippine FDA, post-market surveillance, adverse event reporting, and all other compliance activities required to maintain market access.
Why Appoint a Local Authorised Representative in the Philippines?
- Meet mandatory Philippine FDA requirements for foreign manufacturers
- Ensure reliable communication with regulatory authorities
- Navigate submission and approval procedures with local expertise
- Maintain long-term compliance through structured post-market and vigilance activities
- Support your presence in a growing and increasingly regulated healthcare market
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 FDA 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 Philippines 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 the Philippines , 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 Philippines 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 Local Authorized Representative (LAR) in the Philippines
According to Administrative Order 2020-0017, the following legal requirements must be met for a Local Authorized Representative (LAR) in the Philippines:
Local authorised representative in the Philippines
The Food and Drug Administration (FDA) or medical device authority in the Philippines requires foreign manufacturers who have not set up their own legal subsidiary to appoint a Local Authorized Representative (LAR), sometimes referred to as the in-country representative or local agent.
Andaman Medical has been a local authorized representative in the Philippines since 2017.
What are the (legal) requirements for a LAR in the Philippines?
- As per Administrative Order 2020-0017, all establishments whether public or private, engaged in the business or operation of health products like medical devices must secure a License to Operate (LTO) issued by the FDA and when applicable, the relevant product market authorizations i.e. Certificate of Product Registration (CPR), Certificate of Product Notification (CPN), before engaging in the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship activities.
- The Local Authorized Representative must be authorized Importers/Distributors duly appointed by the foreign manufacturer to represent them and register their products in the Philippines
- The LAR must employ a Qualified Person.
Can you appoint multiple marketing authorization holder or registrants in the Philippines?
- Yes, multiple Local Authorized Representatives are allowed in the Philippines as long as the Distributorship Agreement or Letter of Authorization (LOA) specifies that it is non-exclusive.
- The appointment of a Local Authorized Representative is carried out by issuing a notarized/authenticated/apostilled Distributorship Agreement or Letter of Authorization (LoA) by the foreign manufacturer to the LAR.
- The LoA allows the in-country representative to act as the Importer/Distributor and registrant of the medical device in the Philippines.
- The length of validity of the LOA depends on the manufacturer but usually validity is given for 5 years. A revalidated notarized/authenticated/apostilled LoA shall be issued again 3 months before expiry.
How Andaman Medical can help with in-country representation in the Philippines:
As your marketing authorization holder or local authorized representative in the Philippines we will:
- represent your company in all dealings with the FDA and other authorities responsible for medical devices and in-vitro diagnostics including:
- registering your product
- importing your product
- obtaining other permits and license from other regulatory agencies if applicable
- submitting change notifications
- transferring product licenses
- ensuring post-market surveillance once your product is authorized and placed in the market, including reporting Adverse Events and Field Safety Corrective Actions
- ensure that the medical device or IVD is correctly labelled and that information is provided in English
- provide appropriate storage conditions to maintain the safety and quality of imported products
- maintain importation and distribution records (which is required as part of the FDA audit)
- accept all calls from the FDA regarding the foreign manufacturer and its products and liaising accordingly with the foreign manufacturer including scheduling inspection(s) of the manufacturer’s facilities, if required
- maintain our office including a telephone and email connection in the Philippines
- assist with complaint handling
- monitor regulations to alert you to any changes or new regulations applicable to your product.
Obtain a quote for in-country representation services in Philippines
Why Choose Andaman Medical?
