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 Authorised 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 Philippines?
Can you appoint multiple marketing authorization holder or registrants in the Philippines?
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:
- registering your product
- importing your product
- obtaining other permits and license from other regulatory agencies if applicable
- submitting change notifications
- transferring product licences
- ensuring post-market surveillance once your product is authorized and placed in the market, including reporting Adverse Events and Field Safety Corrective Actions