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A Marketing Authorization Holder (MAH) is the entity that holds the product registration or marketing authorization for a medical device, pharmaceutical, or cosmetic product in a given country, and bears full legal and regulatory responsibility for the product placed on the market. In many APAC markets — including South Korea, Thailand, Indonesia, and Vietnam — foreign manufacturers are restricted from directly obtaining or holding registrations. A locally incorporated entity or a recognized local partner must therefore act as the MAH. Without a qualified MAH in place, market entry may be entirely blocked, and maintaining or renewing an existing registration can become extremely difficult.

Yes, requirements vary significantly by jurisdiction. In South Korea (MFDS), only a locally licensed manufacturer or importer may apply for and hold a marketing authorization. Thailand (TFDA) and Indonesia (BPOM) similarly restrict registration ownership to local entities. In Singapore, HSA requires a locally incorporated entity to act as the Product Registrant for medical devices, or the Product Licence Holder for pharmaceuticals and cosmetics. We assess the regulatory requirements and risks specific to each market and product category, and propose the most suitable MAH structure for your business model.

The MAH carries legal responsibility for the full scope of regulatory compliance in that country — including registration maintenance, adverse event (AE) reporting, recall management, promotional and advertising material approvals, and post-market surveillance (PMS) or pharmacovigilance (PV) obligations. If a partner fails to fulfill these responsibilities, or if the business relationship comes to an end, transferring the authorization can be a complex process that risks interrupting your sales. Structuring the arrangement correctly from the outset — covering contract terms, license transfer clauses, and the clear allocation of PMS/PV responsibilities between both parties — is essential to protecting your market position.

In some cases, yes — but the transfer process and eligibility criteria differ considerably by country and product category. Certain markets do not permit transfers at all, requiring a completely new registration application. When that is the case, careful timeline management is critical to avoid any lapse in registration coverage between the expiry of the existing authorization and the grant of the new one. We support the entire process, from assessing transfer feasibility and preparing submission documents to managing all correspondence with the relevant regulatory authority.

Yes. By acting as your local MAH, we hold and manage your product registrations and marketing authorizations on your behalf, enabling market entry without the need to establish a local subsidiary at the outset. This is an effective way to reduce upfront investment while validating the market. That said, depending on your distribution structure, tax and customs considerations, and long-term growth plans, there may come a point where setting up a local legal entity becomes the more advantageous approach — and we are equally equipped to support a phased transition when that time comes.

Timelines vary by market and device class. Singapore HSA Class B takes approximately 170–185 days; Class C takes 240–255 days. Malaysia NPRA Class C runs 140–150 days. Indonesia BPOM typically requires 210–390 days. Vietnam IMDA ranges from 140–390 days, and Thailand TFDA from 105–200 days. We manage the full submission process across all target markets simultaneously, coordinating dossier preparation, agency correspondence, and deficiency responses to reach approval as efficiently as possible.

In Singapore, the License Holder is the entity registered with HSA as legally responsible for the product's regulatory compliance — including post-market obligations. The distributor is the commercial entity that imports and sells the product. Keeping these roles structurally separate through an independent License Holder means you can change distribution partners at any time without triggering re-registration, protecting both your regulatory standing and your commercial flexibility.