The licence holder will not cooperate with the handover
The product certificate is held by a former agent or distributor, and when the relationship ends, the authorisation, documents or transfer paperwork never materialise.
Medical Device Registration Transfer & Independent Licence Holding
Licence holder not cooperating, or a distributor-held registration that is not opening up sales?
MediPass assesses change-of-holder (transfer) or re-registration options, and its local companies take on licence holding and registration maintenance, so you can choose and develop your own distribution channels.
Singapore · Malaysia · Thailand · Vietnam · Indonesia
Assess My Transfer PlanAlready hold a local registration? Send it over and we will first identify the workable route.
Do any of these sound familiar?
The distributor holds the licence, but sales are not taking off
The product is registered, yet the channel has not been built. You want to change sales partners but are constrained by the existing holding arrangement.
You want to develop several distribution channels
Separate licence holding from sales so that changing distributors does not disturb the registration, while each channel’s import, supply and regulatory responsibilities are properly in place.
Two routes to regain control of your registration
Route 1
Change of licence holder (transfer)
Review the existing certificate, product scope and authorisation chain; list the documents and cooperation required from the current holder; help prepare the change application and arrange the handover of technical documentation, regulatory records and ongoing maintenance.
Route 2
When a transfer is blocked, assess re-registration
If the current holder cannot cooperate, or a transfer is not the right route, we assess the feasibility of a fresh filing by a MediPass local company. We map the technical documentation that can be reused, existing approvals and the documents still missing; where the product qualifies for a local abridged or reliance route, that is included in the comparison to reduce duplicated preparation and shorten the time back to market.
Where the current holder does not cooperate and re-registration is assessed as feasible, MediPass can file a new registration for you through its local company, without depending on the original holder, and offers a substantial discount in support.
MediPass holds the licence. You control the sales channels.
You choose, develop and manage your distribution network. The MediPass local company takes on licence holding, registration maintenance and regulator liaison as agreed, works with the distributors you appoint, and coordinates compliant import and subsequent regulatory matters. The holding arrangement should serve your market development, rather than tying your channel choices to a single licence-holding partner.
The manufacturer provides accurate product information and remains responsible for product quality and safety; the MediPass local company fulfils the agreed licence-holding and local regulatory obligations.
The annual holding fee starts one year after the certificate is issued
The registration/transfer service fee, annual holding fee, government fees and any third-party costs are itemised, each stating what it covers and from which day it is counted; amounts are quoted by country and product and written into the service contract.
Submission and reviewNo holding fee
First year after issueNo holding fee
From one year after issueAnnual holding fee as agreed
For a transfer, the approval date is the starting point. Nothing accrues during review, and nothing is counted from the signing or submission date.
Government fees at cost
Settled against the authority’s bill with no mark-up; receipts provided at settlement.
Unlimited authorisation letters
Issued as needed during the year at no extra charge; for posted originals only the courier cost is borne by the recipient.
Transfer out at any time
No minimum term and no penalty for not renewing; a transfer follows the local procedure and MediPass supports it without a cooperation fee.
Fee details and scope
Registration / transfer service fee
Per project · quoted by country and product
Covers: document review and preparation, submission, responses to queries and correspondence with the authority until the certificate is issued (for a transfer, until approval).
Excludes: government and third-party fees, which are settled separately at cost.
Annual holding fee
Per country · from one year after issue
Covers: licence holding by the local company, authorisation letters, regulator liaison, coordination of adverse-event and reporting duties, renewal reminders, and the documents needed for import customs clearance.
Excludes: change notifications, renewal applications and specific incident handling, which are quoted per project.
Government and third-party fees
As billed · at cost
Government fees: application, registration and evaluation fees charged by the authority and its appointed bodies, passed through at the billed amount.
Third party: testing, certification and courier settled at cost; government fees and the new holder’s charges on a transfer out are borne by you.
Request a quoteTell us the product and target countries; we confirm the route and quote item by item.
Licence-holding rules in five countries at a glance
Each country regulates who may hold a licence and how a change of holder works differently. The table is a summary; the actual procedure must be confirmed case by case against current rules and your existing certificate.
| Country | Licence holder | Change of holder | If the current holder does not cooperate |
|---|---|---|---|
| Singapore | Local registrant, authorised by the product owner | Under HSA’s Change of Registrant procedure, applied for by the new registrant, with the product owner’s request letter and authorisation and a declaration signed by the current registrant | The transfer cannot be completed; alternative routes must be assessed Singapore registration guide →Singapore transfer explained: HSA change of registrant → |
| Malaysia | Authorised Representative (AR) holding an MDA establishment licence | Under MDA’s Change of Ownership procedure, applied for by the new AR, with the manufacturer’s authorisation and request letter; the current AR signs a declaration and returns the registration certificate | The feasibility of a separate registration by the new AR must be assessed under current MDA rules Malaysia registration guide →Malaysia transfer explained: MDA change of AR → |
| Thailand | Local importer holding a Thai FDA import establishment licence | Possible under the Thai FDA transfer procedure: same manufacturer and product owner, the current registration still valid, and a consent letter and other documents submitted; the original registration is cancelled on completion | The documentation required for a filing by the new importer, and its relationship to the existing registration, must be assessed Thailand registration guide →Thailand transfer explained: Thai FDA transfer → |
| Vietnam | A Vietnamese enterprise authorised by the product owner, or the representative office of a foreign trader | A change of holder requires the new holder to re-apply for registration on the strength of the product owner’s authorisation | The new holder can re-apply for registration; where the former holder is no longer authorised and no replacement has been designated, the original registration number can be revoked Vietnam registration guide →Vietnam transfer explained: change of registration holder → |
| Indonesia | A suitably licensed local distributor, applying for the marketing authorisation (Izin Edar) under the manufacturer’s authorisation | A change of distributor requires a new Izin Edar application | Termination of the appointment by the manufacturer can form the basis for revoking the original Izin Edar Indonesia registration guide →Indonesia transfer explained: change of licensed distributor → |
MediPass local entities and credentials in five countries
Transfers and independent licence holding are carried out by MediPass’s locally incorporated companies in each country. Below is a summary of each entity’s operating licences and quality-system credentials; certificate copies are available for client due diligence on request.
Singapore
MediPass Pte. Ltd.
- HSA medical device importer’s licenceMDIL260115W05 · valid to Jan 2027
- HSA medical device wholesaler’s licenceMDWL260115L06 · valid to Jan 2027
- SS620:2016 GDPMDS good distribution practice certificationGDPMDS-SG-082 · TCSPL (SAC-accredited) · valid to Dec 2028
Malaysia
Medipass Sdn. Bhd.
- MDA establishment licence · Authorised Representative (AR)MDA-10150-W126 · valid to Mar 2029
- MDA establishment licence · Importer / DistributorMDA-10171-P126 · MDA-10149-D126 · valid to Mar 2029
- MDA/RR No.1 GDPMD good distribution practice certificationCertificate No. 4260477 · LEADER · valid to Feb 2029
Image unavailable
Thailand
MediPass Healthcare Solutions (Thailand) Co., Ltd.
- Thai company registration (DBD)Reg. No. 0105569151507 · Department of Business Development · Bangkok
- Thai FDA medical device importer establishment registrationReg. No. สน. 175/2569 · valid to 31 Dec 2030 · covers 14 product areas, including clinical laboratory, anaesthesia, cardiology, surgery and medical IT
Vietnam
Công ty TNHH Medipass Việt Nam
- Declaration of eligibility to trade Class B, C and D medical devicesDeclaration No. 260000166/PCBMB-HCM · Ho Chi Minh City Department of Health · declaration-based, no fixed expiry
- Public verificationSearchable on the Ministry of Health medical device management system (vimda.moh.gov.vn)
Indonesia
PT Medipass Indonesia Sejahtera
- CDAKB medical device good distribution practice certificatePB UMKU 080426009746700010038 · Ministry of Health / OSS · status: valid (Berlaku)
- Business scopeKBLI 46791 wholesale of medical and laboratory equipment
- Prerequisite licenceMedical device distribution licence (IDAK)
Summary information only; validity is as recorded by the issuing authority. Images are certificate excerpts and do not include signature pages.
Frequently asked questions
What if the current licence holder will not cooperate?
In most countries a transfer needs documents signed or supplied by the current holder. When they do not cooperate, we assess alternative routes such as re-registration against local rules and your existing authorisations, and set out what each party needs to provide.
Can the product simply be re-registered?
It depends on the country. In Vietnam and Indonesia, a change of holder itself requires the new holder to re-apply for registration; in Singapore, Malaysia and Thailand it has to be judged case by case against the status of the existing registration and authorisations.
Once holding and sales are separated, does changing a distributor mean re-registering?
Where the licence holder stays the same, changing a distributor normally does not involve a transfer, but the new distributor still needs the import or operating licences required locally. In Indonesia the marketing authorisation is held by the distributor, so the division of roles works differently; we set this out separately in the proposal.
What does the annual fee include?
The annual fee is per country and covers licence holding by the local company, authorisation letters, regulator liaison, coordination of adverse-event and reporting duties, renewal reminders and the documents needed for import customs clearance; the quotation states the countries, products and service period it covers.
New product registrations, change applications, renewal applications, government fees and specific incident handling are quoted separately, with the quotation stating whether each is included and how it is charged. See Fee structure.
When does the holding fee start?
The annual holding fee is counted from one year after the certificate issue date; for a transfer, one year after the authority approves it. No holding fee accrues during the review period, and nothing is counted from the signing or submission date. Some providers start charging holding fees from signing or submission; we do not.
Is there a penalty for changing licence holder mid-way?
No. There is no minimum term and no penalty for not renewing. When you decide to transfer out, MediPass supports the transfer without a cooperation fee and continues to fulfil its holding duties until the transfer is complete. Government fees and the new holder’s charges for the transfer are borne by you.
Does the service include import, warehousing or product sales?
Licence-holding services do not automatically include these commercial operations. If you need import coordination, warehousing, customs clearance or sales support, let us know at the enquiry stage and we will define the work, the responsible company and the fees.
Let’s talk about your situation
Tell us about the product and target country, or share the public details of the current registration, and we will help assess the options.