All topics
Mode B holder / transfer or re-registration / contract protection
Switching Medical Device Distributors: What Happens to the Registration Certificate?
A Mode B country matrix showing who holds the medical-device registration, what happens when the distributor or local holder changes, and which contract protections the country page explicitly documents.
The direct answer
In mandatory local-holder (Mode B) markets, the certificate is usually held in the distributor's or another local entity's name. Switching distributors can require anything from a formal transfer or variation application to full re-registration. The protection must be built before signing, not after the relationship breaks down.
Evidence boundary
The country set follows the Mode B box in the entity-strategy topic. Every holder, switching, and contract-protection statement below comes only from Element 2 or the equivalent license-holder section of the linked English country page. — means that section does not state a contract protection. 【待核验】 is preserved where the source page uses it.
Mode B distributor-switching matrix
| Country | Whose name is on the certificate | What happens when the holder or distributor changes | Contract protection stated on the country page |
|---|---|---|---|
| Indonesia | A local IDAK/CDAKB holder: own PT PMA subsidiary, distributor, or neutral third party | If the distributor holds the licence, changing distributors means re-registering under the new IDAK; reported delay is 6–12 months and the outgoing distributor must cooperate. | Define dossier ownership, handover duties, PMS and recall responsibility, and a transition timeline. |
| Thailand | A Thai establishment-licence holder: own subsidiary, local distributor, or independent LAR | If the distributor is the holder, the registration does not transfer automatically; renegotiation or re-registration can interrupt supply. An independent LAR lets commercial distributors change without re-registering the product. | — |
| Vietnam | A Vietnam-established Authorized Representative (own subsidiary, independent AR, or distributor) | If the distributor is also the AR, changing partners generally requires a formal certificate-variation application and can interrupt supply. An independent AR keeps the registration outside the distributor relationship. | Establish technical-data-package ownership and transition arrangements from the outset. |
| Malaysia | A Malaysia-incorporated Authorized Representative with an MDA Establishment Licence and current GDPMD certificate | If the distributor is the AR, changing partners generally requires a formal transfer or variation application and can interrupt supply. An independent AR avoids this specific risk. | Define certificate ownership, data-package access, and transfer terms before signing. |
| Philippines⚑ | A Philippine LTO holder: own subsidiary, commercial distributor, or neutral third party | If the distributor holds the certificate, changing distributors requires a formal CDRRHR variation described as cumbersome and dependent on the outgoing distributor. The timeline is not stated. 【待核验】 | Define dossier ownership, CMDR variation procedures, PMS and recall responsibility, and a transition timeline. |
| South Korea | A Korea License Holder (own subsidiary, distributor, or independent third-party KLH) | Changing the KLH generally requires a formal holder-change filing or, in some cases, a fresh registration; neither is instantaneous, and uninterrupted supply should not be assumed. A third-party KLH lets distributors change without re-filing the product. | — |
| Taiwan | A Taiwanese licensed agent holding a Medical Device Business Permit | Changing agents requires a formal certificate-variation (Sponsor change) filing. It is not instantaneous, and uninterrupted supply should not be assumed. | Keep technical-data ownership with the manufacturer; require transfer cooperation on termination; scope exclusivity so it cannot block a future agent change. |
| India | An Indian Authorised Agent holding Form MD-15: own subsidiary, distributor, or third-party specialist agent | The outgoing agent must cooperate in a change/transfer filing, or the manufacturer must file a fresh MD-14/MD-15 application through a new agent. Imports are suspended during the transition either way. | Cover dossier custody, outgoing-agent cooperation, inventory/safety/complaint-record handover, and a notice period that overlaps agent onboarding. |
| Australia | An Australian Sponsor holding the ARTG entry | A Sponsor Change application requires TGA approval, takes about 2–4 months, and allows the product to keep selling during the process. | Specify ARTG transfer, manufacturer ownership of the technical data package, and the conditions and procedure for Sponsor change. |
| Argentina | An Argentina-incorporated Importador Autorizado | The registration does not transfer automatically. A Transferencia de Titularidad requires the outgoing importer's cooperation and can interrupt supply. | Require transfer to a manufacturer-designated successor within a defined timeframe and keep independent ownership and custody of the technical dossier. |
| Colombia | A Colombia-based Titular del Registro, usually the local importer or distributor | Changing the Titular requires a formal Cesión del Registro, stated at approximately 3–6 months; the manufacturer does not automatically regain certificate control. | Define registration ownership, dossier access, safety-reporting responsibility, and exit/transfer terms before signing. |
| Brazil | A Brazil Registration Holder (own subsidiary, independent regulatory-only BRH, or distributor) | Alteração de Titular requires the outgoing BRH to cooperate. An uncooperative BRH can stall the transfer and freeze imports for 6–12 months; BGMP certification is tied to the specific BRH and cannot be transferred. | Cover data access, PSUR support, transfer cooperation, and, where relevant, BGMP continuity. |
| Chile | The local importer / legal representative | Changing the holder requires a Cambio de Titular application to ISP; no fixed duration is stated. | Specify certificate ownership provisions contractually. |
| Russia / EAEU | An EAEU-registered Authorized Representative (AP) | Changing the Authorized Representative requires a certificate-variation application; supply must not be interrupted during transition. Sanctions or compliance restrictions on the representative can place the certificate in a legal gray area. | — |
| Saudi Arabia | A Saudi Authorized Representative; the MDMA is typically issued in the SAR's name | Transfer to a new SAR requires a formal SFDA application and is described as time-consuming with meaningful outcome uncertainty. | State that the SAR holds the MDMA on the manufacturer's behalf; preserve manufacturer-directed transfer rights; prohibit unilateral revocation or amendment; define breach and exit consequences. |
| Egypt | The Egyptian local importer / agent | Changing the importer requires a Registration Transfer application to EDA; the process is complex, and the importer may refuse to transfer without a contractual right. | Explicitly grant the manufacturer the right to certificate transfer. |
| Kuwait | Typically the local licensed agent; sometimes the manufacturer, with the agent as responsible contact | Agent changes must be reported to the Ministry of Health and may require re-review. | Explicitly specify certificate ownership and transfer provisions. |
| Nigeria | The NAFDAC-licensed local importer | Changing the importer requires a Registration Transfer application to NAFDAC; the process is complex and requires both parties' consent. | Explicitly specify the manufacturer's certificate rights and transfer provisions. |
| United Arab Emirates | A qualified local agent; the certificate is typically in the agent's name | When the agent relationship ends, marketing-authorization ownership becomes the page's greatest stated commercial risk; transfer depends on the agent's cooperation. | State that the MA belongs to the manufacturer, require transfer cooperation on termination, and prohibit unilateral revocation. |
Three protections before signing
These are the three existing Mode B choices from the entity-strategy framework, reorganized around distributor switching rather than expanded with new claims.
Use a neutral third-party holder where documented
Keep the certificate outside the commercial distributor relationship so sales partners can change without disturbing the product registration where the country page documents that structure.
Lock transfer rights into the contract
Set certificate ownership, dossier access, transfer cooperation, termination handling, and transition duties before launch rather than after a dispute.
Use an own subsidiary only where direct control justifies the burden
An own local entity gives the manufacturer full certificate and distributor control, but carries the highest setup cost and the recurring local-holder obligations directly.
Choose the holder structure before choosing the distributor
Use the entity-strategy pillar to compare the three holder models, then open the country index for the complete filing and local-obligation context.