Registration status across Asian markets is often the last thing checked in a deal — and the most expensive to miss. Here's what to look for and how to find it.
In a medical device acquisition or distribution deal, the commercial case drives the process. Revenue projections, product differentiation, customer relationships, IP ownership — these get the attention. Regulatory due diligence, particularly for Asian markets, often ends up as a checklist item toward the end: "confirm registrations are in order."
The problem is that "confirming registrations are in order" across eight Asian regulatory systems is not trivial. Each market has its own registry, its own data format, and often its own language. Most acquiring companies don't have the in-house capability to query all eight systems efficiently. So they either skip it, or they rely on the seller's representation — which is not the same thing as verifying it.
This matters because registration deficiencies are expensive to fix after the fact. A lapsed registration in Indonesia means the product can't legally be imported until it's renewed or re-registered, which takes months. A registration that was held by a distributor you just terminated doesn't automatically transfer — you may need to re-register under your own entity, which means another full registration process. These are material revenue impacts, not paperwork problems.
Start with the basics: how many active registrations does the target company have, and in which markets? A company claiming to have a strong Asian presence should have registrations to back it up. If they're selling in five countries but only have registrations in two, find out why. Informal market presence without registration is a liability.
Registration validity periods vary by market — most are 5 years, but some have different cycles. A portfolio where 60% of registrations expire within 18 months of closing is a hidden cost that should affect deal economics. Renewal is not automatic and requires filing effort. In markets where the regulatory agent relationship needs to be transferred, the renewal process is more complex.
This is the most frequently overlooked element. In Indonesia, Malaysia, and Thailand, registrations must be held by a local authorized representative or importer — not the foreign manufacturer. If you're acquiring a device company, you need to know whether the registrations in these markets are held by the target company's local subsidiary, by an independent local distributor, or by some other entity.
If the registrations are held by an independent local distributor, those registrations belong to that distributor — not to the company you're acquiring. You're not buying those registrations; you're buying a relationship that currently has access to the market via that distributor's registrations. That's a different thing, with different risks.
Active registrations tell you the current legal picture. Lapsed registrations tell you about the regulatory track record — a company with many lapsed registrations may have had management or funding issues that affected their compliance posture. Pending registrations tell you about the pipeline: registrations in process that aren't generating revenue yet but represent future market access.
Search by company name and see active, lapsed, and pending registrations across BPOM, HSA, MDA, FDA-TH, PMDA, MFDS, NMPA, and DAV — in a single search.
Start searching free →This scenario plays out regularly enough that it deserves its own section. A foreign manufacturer enters Indonesia, Malaysia, or Thailand through a local distributor. The distributor handles the registration — it goes in their name as the local authorized representative. The distribution relationship goes well for a few years. Then something changes: the distributor underperforms, gets acquired by a competitor, or tries to renegotiate the agreement from a position of leverage.
The leverage is real: the distributor holds the registrations. If you terminate the agreement, the registrations stay with them. Your product can no longer legally be sold in that market until you complete a new registration under a new local entity — a process that takes months to over a year depending on the market and device class. Meanwhile, your former distributor can potentially continue selling their stock, or negotiate from a much stronger position than they should have.
The right time to address this is in the original distribution agreement, not after the relationship deteriorates. A well-structured distribution agreement for markets with local registration requirements should specify:
If you're conducting due diligence on a target company that has distribution agreements in these markets, check the agreements. Are the registration transfer provisions clearly spelled out? If not, that's a negotiation or legal risk that belongs in the deal structure.
When reviewing a target company's Asian registration profile, the following patterns warrant additional scrutiny:
Meridian Trace indexes registration data from all eight major Asian markets — BPOM (Indonesia), HSA (Singapore), MDA (Malaysia), FDA-TH (Thailand), PMDA (Japan), MFDS (South Korea), NMPA (China), and DAV (Vietnam). A single search by company name returns registration records across all markets simultaneously.
For due diligence purposes, the workflow is:
Export the results to CSV (on Professional tier) and you have a structured registration inventory that can go directly into the due diligence data room.
Search any company's registration footprint across 16 global markets simultaneously. Start with 50 free searches.