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.