Practical Path for Registration Transfer: Handover from the Old Holder to the New

1. Key takeaways

Transferring a Philippine registration, in practice changing the MAH, requires three preconditions: the original agreement is terminated, a new agreement is signed, and the original certificate is in hand. Once those are satisfied, the change is filed with the FDA through the variation procedure. If the three conditions cannot all be met, the alternative is a fresh registration by the new holder, since the Philippines allows the same product to be registered separately by different MAHs.

• The administrative step is a variation. The difficulty is almost always commercial, not procedural.
• Multiple registration is a genuine fallback but not a free one: it repeats the fee, the dossier and the waiting time.
• The new holder must hold a valid LTO whose activities cover device import and distribution, and the new LOA must be notarised and Apostilled.
• Under AO No. 2025-0030 the MAH is the party responsible for vigilance, so the transfer must include a defined handover date.
• The economics of the two routes depend on whether the AO 2024-0016 fee schedule is in force, so the choice should be revisited as the policy position changes.

2. Legal basis

AO No. 2018-0002 of 26 January 2018 provides that the registration certificate is issued to the applicant, which is the MAH, and that changes to the registered information are handled through the variation procedure with payment of the applicable fee. The three preconditions for a transfer, namely termination of the original agreement, signature of a new agreement and possession of the original certificate, are compiled from industry practice rather than set out as a single article. Because the Philippines permits multiple registrations of the same product by different holders, a new MAH may instead apply in its own name. The new holder must hold a valid LTO covering device import and distribution, and the new LOA must be notarised and Apostilled. Post-market responsibility is fixed by AO No. 2025-0030, effective 6 May 2026.

3. Expert insights

The transfer is difficult commercially, not administratively. On paper, a transfer is one variation application. The real obstacle sits on the commercial side: whether the outgoing holder is willing to cooperate. If the agreement contains no handover obligation on termination, the old holder is free to withhold the original certificate and to decline to sign the supporting documents, which leaves the transfer at a standstill regardless of what the manufacturer wants. That is why GRZAN repeatedly stresses that transfer clauses have to be written at the time of signing, not negotiated at the time of separation.

Multiple registration is the Philippine escape route, but it carries a price. Unlike some Southeast Asian markets, the Philippines allows the same product to be held under separate certificates by different MAHs. A manufacturer can therefore proceed without the cooperation of the outgoing holder by having the new holder apply in its own name. The price is that the official fee, the dossier preparation and the waiting time are all repeated, and until the new certificate issues, the old certificate remains the only lawful basis for market access. The fallback solves the deadlock; it does not remove the cost.

The fee moratorium changes the economics of the two routes. While AO 2024-0016 is suspended, the cost of a fresh registration sits at a low level, and multiple registration is clearly more attractive than accommodating an uncooperative incumbent. Once the new fee schedule is restored, the cost of registration may rise by an order of magnitude, at which point negotiating a transfer through the agreement becomes the preferred option again. This is a decision that moves with the policy window rather than a rule that can be settled once.

There must be no vacuum in post-market responsibility during the transfer. AO No. 2025-0030 makes the MAH the responsible party for vigilance. If responsibility is unclear during a transfer and an adverse event occurs, nobody is under a clear obligation to report it, which creates a direct compliance exposure. GRZAN recommends that the agreement state that from a specified date vigilance responsibility rests with the new MAH, and that the old MAH is obliged to hand over information on known events from the transition period.

4. Practical recommendations

• Lock four handover obligations into the contract at signing. Within a defined number of working days after termination the outgoing holder must deliver the original certificate, the complete registration file, the original LOA and copies of the technical documentation.
• Write a cooperation obligation and a liquidated remedy into the agreement. State that the outgoing holder must sign the variation documents, and attach a financial consequence to failure, so that cooperation does not depend on goodwill.
• Keep a full duplicate of the file at the manufacturer. Do not hand the entire dossier to the holder and retain nothing; holding a complete copy is what prevents the manufacturer from being held to ransom at the moment of transfer.
• Verify the new holder’s LTO before the transfer begins. Check the licence number, the expiry date, the activity type and the qualified person, exactly as for an initial application.
• Schedule the vigilance handover date at the same time as the filing. Define the switch-over date explicitly and record it, so that reporting responsibility never falls between two holders.

5. Verification checklist

• □ Evidence of termination of the original agreement: termination agreement or notice letter.
• □ New agreement and new LOA signed; LOA notarised and Apostilled.
• □ Original certificate physically available for verification.
• □ New holder’s LTO valid, confirmed through the FDA Verification Portal.
• □ Variation application filed and the FDA receipt retained.
• □ Vigilance responsibility switch-over date stated in the agreement.
• □ Fallback option assessed with a cost and timeline estimate for fresh registration.

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