Know What You're Walking Into Before You Start Filing

The research that should happen before the filing

Before you commit to a distributor, start a registration filing, or present a market entry proposal internally, it's worth knowing what the competitive landscape looks like in that market. What devices in your category are already registered? Who are the major players and how many markets are they in? Is this a crowded market or one with relatively few active registrations in your category?

This information exists in public regulatory databases. The problem is that accessing it the manual way — logging into five different government portals, each with its own search interface, each returning differently structured results — takes weeks of analyst time. And the results are still siloed by market, which means the cross-market comparison you actually need is another layer of manual work on top.

Meridian Trace is built to make this research fast and systematic. One search query surfaces results across all eight covered markets, with consistent field names and normalized company data.

What market entry research actually involves

A proper pre-entry assessment of a new Asian market should answer at least these questions:

• Who's already registered in my product category? Which manufacturers have active registrations, how many, and which sub-categories do they cover?
• What's the registration activity trend? Are new registrations in this category increasing, flat, or declining? That's a signal about market dynamics that revenue data won't always capture.
• Which companies have registrations in multiple markets? A competitor with registrations in five ASEAN markets is making a different strategic bet than one that's only in Singapore. That shapes how you should think about your own sequencing.
• Are there any competitors with lapsed registrations? A lapsed registration can signal market exit, a distributor relationship breakdown, or a product line that didn't perform. Worth knowing before you decide how aggressively to pursue a market.
• Who holds the local license holder registrations in markets like Indonesia and Malaysia? In markets where local importers hold registrations on behalf of foreign OEMs, identifying those relationships tells you who your competitors are actually working with on the ground.

How to do it in Meridian Trace

The basic workflow is straightforward. Search by your product category or a competitor name. Use the market filter to narrow to the specific markets you're assessing, or leave it open to see cross-market results at once. Filter by registration status (active, lapsed, or all) depending on what you're trying to understand.

For a category-level assessment, searching by a product description term or GMDN code gives you a landscape view — how many registrations exist in the category, which companies hold them, and how they're distributed across markets. Export to CSV for Professional accounts and you can run your own analysis in a spreadsheet.

For a competitor-specific assessment, search by manufacturer name. Meridian Trace normalizes company names across registries, so you'll get results for a company even if they're registered under slightly different legal names in different markets.

Related reading

• BPOM Medical Device Registration in Indonesia: What You Actually Need to Know
• How Singapore's HSA Registration Works (And Why Companies Get It Wrong)
• Track Competitor Registrations Across Asian Markets
• Regulatory Due Diligence Before Signing a Distribution Agreement
• Indonesia (BPOM) Registration Database
• Singapore (HSA) Registration Database