The honest version of how Meridian Trace came to exist and how the data actually works.
The original problem was simple: we were trying to understand the medical device regulatory landscape across Southeast Asia before a market entry project, and we couldn't find a single tool that made it possible without either hiring a consultant or spending weeks manually pulling data from four or five government portals — each with its own search interface, its own field naming conventions, and its own quirks about what it would and wouldn't return.
The official databases are free and publicly accessible. That part is fine. The problem is that they were built for regulators, not for market researchers. They're not designed for cross-market comparison, bulk export, or normalized company name search. If a manufacturer is listed as "Medtronic Inc" in Indonesia, "Medtronic International Ltd" in Singapore, and "Medtronic (Malaysia) Sdn Bhd" in Malaysia, a naive search for "Medtronic" across three separate portals might miss all three.
We built Meridian Trace to fix that specific problem. It's a normalized, searchable layer on top of public regulatory data from eight Asian markets — with company name resolution, translated product descriptions, and OEM inference for markets where a local distributor is listed as the manufacturer of record.
We pull data from official government regulatory databases across eight markets:
Each registry has different data structures, different classification systems, and different levels of completeness. We normalize these into a consistent schema so you can compare records across markets with consistent field names and logic.
Beyond the raw scraped data, we add several things that don't exist in any single registry:
Company name normalization. The same manufacturer appears under dozens of different legal name variants across markets. We collapse these into a single entity so a search for "Siemens Healthineers" returns records filed under subsidiary names, local distributors trading on the Siemens name, and common abbreviations.
OEM inference. In Indonesia, Malaysia, and Thailand, the regulatory registration is held by a local importer or distributor — not the foreign manufacturer. The device is listed under the local company's name. Where we can identify the underlying OEM (through product names, cross-market comparison, or other signals), we flag the inferred manufacturer separately. We're clear about when this is a Meridian Trace inference versus a scraped fact.
Product name translation. Several markets have registration records primarily in local languages. We translate product names and descriptions into English where they're not already provided.
Risk normalization. Classification systems vary by market. Indonesia uses Class A-D, Japan uses Class I-IV with separate high-risk implantable categories. We normalize these to a consistent Low / Medium / High scale for cross-market comparison.
Every field in a Meridian Trace registration record is tagged with its source: either it was scraped directly from the source registry, or it was added or modified by us (translated, inferred, enriched, or normalized). We show this in the UI with colored indicators on each field.
This matters for regulatory use. If you're relying on a piece of data for a compliance decision, you should know whether it came verbatim from BPOM or whether it's our inference. We'd rather be transparent and occasionally frustrating than falsely authoritative.
We're not a regulatory consultant. We don't provide regulatory strategy advice, filing support, or submission management. What we provide is data — searchable, normalized, exportable data that replaces the manual work of pulling information from government portals one at a time.
We're also not a real-time compliance monitor. If you need immediate alerts when a specific registration lapses or changes status, that's not something we currently offer — though it's on the roadmap.
And we're not comprehensive everywhere. Some markets have registries that are harder to normalize than others. Vietnam, for example, has less structured data than Singapore's HSA. We flag data quality where it's limited, rather than papering over gaps with false confidence.
Regulatory affairs teams at mid-size medical device companies (typically 50-2,000 employees) who are expanding into Asian markets and doing their own market research. Market access and business development managers who need to understand the competitive landscape in a new market before committing to a distributor relationship. RA consultants running competitive intelligence for clients.
We're not trying to replace Citeline for pharma teams or build a QMS. This is a specific tool for a specific job: understanding what's registered in Asian markets and who holds those registrations.
Questions, data issues, or feedback — hello@meridiantrace.com. If you find a data error, we want to know about it.
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