How Many Medical Devices Are Registered in Indonesia? We Counted.

Indonesia has one of the largest medical device registration databases in Southeast Asia. The BPOM registry — Badan Pengawas Obat dan Makanan — contains over 180,000 medical device registration records when you count both active registrations and historical/lapsed ones. That number is substantially larger than most industry participants expect.

For context: Indonesia has a population of approximately 280 million people. The country imports the vast majority of its medical devices from the US, Europe, Japan, and increasingly from China. That combination — large population, high import dependency — produces a registration database that reflects decades of accumulated filings by manufacturers trying to access one of Asia's most important markets.

Here's what that data shows when you break it down.

By device class: Class A dominates the count

Indonesia uses a four-class system: Class A (lowest risk) through Class D (highest risk). The distribution across classes is heavily skewed toward the lower end:

• Class A represents the largest share of total registrations — somewhere around 50–55% of the total database. This reflects the sheer volume of low-risk products: disposable gloves, bandages, tongue depressors, basic wound care, non-powered examination equipment. These are high-volume, commodity-adjacent products with many manufacturers and many SKUs.
• Class B is the next largest group, approximately 30–35% of the database. Class B includes syringes, blood pressure monitors, non-implantable diagnostic equipment, and a wide range of surgical consumables. This is where mid-risk device competition is most intense.
• Class C accounts for roughly 10–12% of registrations. This includes infusion pumps, powered surgical instruments, and devices with more complex risk profiles.
• Class D is the smallest class by count — under 5% — but includes the most commercially significant device categories: implantable cardiac devices, joint replacements, neurostimulators, drug-eluting stents.

The Class D count being small is not surprising. Class D registration requires the most thorough BPOM review, takes the longest, and typically requires a track record in other markets (FDA, CE) before BPOM will approve. The economics also matter: Class D devices are high-value, lower-volume, so fewer SKUs exist in the market compared to Class A commodities.

By registration status: the lapse rate tells a story

Not all 180,000+ registrations are active. A significant portion — likely 25–35% depending on how you count — represent lapsed registrations: products that were registered at some point but whose registration has since expired without renewal.

Lapsed registrations aren't noise in the data. They tell you something. High lapse rates in a category often indicate:

• Market consolidation — weaker players exiting
• Product generation turnover — older product versions lapsed as newer ones were registered
• Distribution relationship changes — local importers changed, and old registrations weren't renewed under the new entity
• Deliberate market exit — the manufacturer decided Indonesia wasn't worth continued investment

When researching a category in Indonesia, looking at the ratio of active to lapsed registrations gives you a sense of market stability. A category with high active registration counts and low lapse rates is an established, competitive market. A category with many lapsed registrations and few new active ones may be a market that's contracting.

By product category: what's in the database

Breaking down by product category (using standardized medical device category codes) reveals the breadth of the Indonesian market:

• Surgical instruments and equipment: One of the largest categories by count. Includes both non-powered and powered surgical tools, drapes, and procedure-specific consumables.
• In vitro diagnostics (IVD): A major and growing category. The post-2020 expansion of diagnostic testing capacity drove a surge of new IVD registrations that has not fully reverted.
• Diagnostic imaging equipment: Significant, dominated by the larger multinationals (GE, Siemens, Philips, Canon/Toshiba) and increasingly by Chinese manufacturers at the lower-cost end of the spectrum.
• Orthopedic implants: A competitive category with both global majors and regional manufacturers.
• Cardiovascular devices: Class D dominated; primarily multinational manufacturers with established distribution through major hospital chains.
• Wound care and disposables: High volume, highly competitive, with significant local manufacturing as well as imports.

By geographic origin of manufacturer: who's selling into Indonesia

Indonesia's import dependency means the registration database reflects the global medical device industry's composition. US manufacturers are well represented, as are European manufacturers (German, Dutch, Swiss, Swedish device companies are particularly prominent). Japanese manufacturers have strong representation, particularly in diagnostic imaging and surgical instruments.

The biggest shift in recent years: Chinese medical device manufacturers have dramatically increased their Indonesia registration activity. This is most visible in IVD, diagnostic imaging at the lower-cost tier, and certain surgical instrument categories. The speed at which Chinese manufacturers have built registration portfolios in Indonesia — often registering wide product ranges in a short period — is a notable feature of the past five years of data.

Local Indonesian manufacturers hold a portion of the registration database, primarily in Class A and Class B categories. Indonesian domestic manufacturing has been growing, supported by government procurement preferences, but the country still imports the majority of its devices by value.

What this means for market analysis

The 180,000+ number is a ceiling, not a floor of competitive intensity. The active registration count is lower. The number of products actually commercially available and generating material revenue is lower still. But the size of the database reflects how seriously manufacturers have treated Indonesia as a target market — and it shows that the competitive landscape, even in the highest-risk device categories, is well-established.

For any company evaluating Indonesia market entry, the registration database is the most granular public evidence of what the competitive landscape looks like. Who's already there, in what classification, registered under what local entity, with what registration vintage — all of this is searchable and analyzable before you commit to the registration investment.