Philippines Local Authorised Representative: MAH, LOA and Apostille

1. Key takeaways

No. An overseas manufacturer cannot file a product application with the FDA Philippines directly. The application must be submitted by a Philippine entity holding a valid LTO, and that entity becomes the Marketing Authorization Holder (MAH), also described externally as the local authorised representative. The manufacturer must issue that entity a Letter of Authorization (LOA) that has been notarised and then authenticated by Apostille.

This is not a formality that sits at the end of the process. The identity of the MAH is recorded on the certificate itself, so the appointment decision determines who controls market access for the life of the registration. Manufacturers that treat the appointment as a filing convenience typically discover the consequence two or three years later, when they want to change distributor and find that the certificate has to move with the relationship.

• Only a Philippine entity with a valid LTO can file, and it becomes the MAH.
• The LOA must be notarised and Apostilled; the Hague Convention took effect between China and the Philippines on 7 November 2023.
• The MAH carries regulatory responsibility for registration, importation, vigilance and recall.
• Under AO No. 2025-0030, distributors must pass complaints and adverse event information to the MAH within 14 calendar days.
• The LOA should address scope, term, ownership of the registration file and cooperation on termination.

2. Legal basis

The applicant definition in AO No. 2018-0002 is the provision that produces the whole structure, because it describes the applicant as a manufacturer, trader or distributor, importer or exporter applying for a CMDN, CMDL or CMDR, and the establishment licensing rules then limit the LTO to entities established in the Philippines. The authorisation document itself is governed by the Apostille Convention, which replaced consular legalisation for this purpose.

3. Expert insights

Insight one: the holder and the certificate are bound together, and that is the defining commercial feature.

The certificate is registered in the name of the MAH, and the MAH carries the full regulatory responsibility that attaches to it. The direct consequence is that changing the holder means transferring the certificate, which requires a variation procedure. Where the holder is also the distributor, the manufacturer sits at a structural disadvantage in commercial negotiation, because any attempt to change distributor first requires moving the certificate, and the incumbent controls the documents needed to do so.

Insight two: the holder responsibility goes well beyond submitting documents.

AO No. 2025-0030, effective 6 May 2026, names the MAH expressly as the responsible party for post-market vigilance. The MAH must operate a system for receiving, recording, evaluating and investigating complaints, adverse events and field safety corrective actions; must determine whether a complaint is reportable and whether it constitutes an adverse event; and must notify the FDA within the prescribed timelines. At the same time, distributors, whether manufacturers, traders, distributors or retailers, must forward the relevant information to the MAH within 14 calendar days of receiving a complaint or becoming aware of an adverse event. The system places the centre of gravity of responsibility squarely on the MAH.

Insight three: the quality of the LOA terms determines the future cost of transfer.

An LOA is not a single page authorising a company to file. We recommend that it address four matters explicitly: the scope of authorisation, including the product list and the powers granted; the term of authorisation; ownership of the registration file; and the duty to cooperate when the agency is terminated. The fourth item is decisive, because it determines whether the outgoing holder is obliged to assist in a transfer. Without that clause, transfer negotiations begin from a position of weakness, and the timing of the transfer is set by the party with the least interest in completing it.

Insight four: Apostille shortened the Chinese authentication chain, but the order of steps cannot be reversed.

China acceded to the Convention Abolishing the Requirement of Legalisation for Foreign Public Documents on 8 March 2023, and the Convention took effect between China and the Philippines on 7 November 2023. Since then, public documents sent from China for use in the Philippines are no longer consular legalised and are Apostilled instead. The sequence is: the manufacturer signs the LOA, a Chinese notary public notarises it and converts it into a public document, and the Ministry of Foreign Affairs or an authorised local foreign affairs office issues the Apostille. Presenting an unnotarised LOA for Apostille does not work, and this is the step most often misunderstood.

4. Practical recommendations

• Treat the holding arrangement as a commercial decision, not an administrative step. The choice of holder determines future leverage in distributor management, control of the certificate and freedom to switch channels. It should be decided at the same level as pricing and territory, not delegated to a filing agent.
• Build an exit mechanism into the LOA. State the termination conditions, the duty to hand over documents, the duty to cooperate in transferring the certificate and the consequences of breach. A clause that only describes the grant of authority leaves the manufacturer without a remedy at the point it needs one.
• Start the Apostille process four to six weeks ahead. Notarisation plus Apostille takes time, and an LOA has a validity period, so preparing too early can produce a document that has expired by filing and preparing too late delays the submission.

5. Verification checklist

• □ Confirm that the local holder has a valid LTO through the FDA Verification Portal.
• □ Confirm that the LTO activity type covers device importation, as stated on the certificate.
• □ Confirm the four LOA elements: scope, term, ownership of documents and cooperation on termination.
• □ Confirm the LOA authentication chain: notarisation followed by Apostille from the Ministry of Foreign Affairs or a local foreign affairs office.
• □ Confirm that the Apostille can be verified online at https://consular.mfa.gov.cn/VERIFY/.
• □ Confirm that the MAH vigilance obligations are written into the agreement between the parties.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including the Philippines. Our team prepares CMDN/CMDR dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the FDA Philippines, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com