Medical Device License — Verify Before Buying

One of the most common findings in Health Office audits at hospitals: a disinfectant being used without a valid Ministry of Health (Kemenkes) registration. Sometimes because the license has expired unnoticed. Sometimes because the vendor sold a product under another product's license. In the worst case: a forged license that slipped through procurement because the team didn't know how to verify it properly.

The impact stacks: an audit major finding, KARS accreditation delayed, and in serious cases — the facility can't operate until the product is replaced. This article explains Indonesia's medical-device registration system, the correct way to verify (free, 2 minutes), and the red flags every disinfectant/antiseptic procurement should check.

Indonesia's medical device regulatory system

Two regulators are relevant for disinfectants and antiseptics:

Ministry of Health (Kemenkes)

Regulates Medical Devices (Alkes). Including: medical-grade surface disinfectants, pre-surgical skin antiseptics (4% chlorhexidine scrub, povidone iodine), wound antiseptics, and similar. Legal basis: Minister of Health Regulation 62/2017 on Medical Device Registration.

Documents issued by Kemenkes:

Medical Device Production Certificate — for the manufacturer
Medical Device Distribution Certificate — for the distributor/importer
Registration Number (NIE) — for each specific product, valid 5 years

National Agency of Drug and Food Control (BPOM)

Regulates drugs, cosmetics, food. Relevant hygiene products: consumer-grade hand sanitizer (cosmetic category), consumer hand wash, consumer antibacterial soap.

BPOM documents:

Cosmetic Notification Number (NA, NB, NC, ND, NE) — valid 3 years
Drug Registration Number (DK, DL, GK, GKL, etc.) for products in the drug category

Which regulator applies to what?

ProductRegulatorTypical license format Hospital surface disinfectant (H2O2, hypochlorite)KemenkesAKL/AKD + 11 digits (e.g. AKL 20204020356) Surgical hand scrub (CHG 4%)KemenkesAKL/AKD + 11 digits Pre-surgical skin antiseptic (iodine, alcohol)KemenkesAKL/AKD + 11 digits Hospital alcohol hand rubKemenkes (medical device class)AKL/AKD + 11 digits Consumer hand sanitizerBPOMNA + 11 digits Consumer antibacterial hand washBPOMNA + 11 digits WWTP bacteria (IPAL probiotic)Neither (no medical/cosmetic license required)CoA + manufacturer spec suffices

Note: for hospitals and formal healthcare facilities, professional hand-hygiene products should carry a Kemenkes Medical Device license, not a BPOM Cosmetic. A vendor offering "medical hand wash" but with an NA cosmetic license = a category mismatch.

How to verify a Kemenkes license — free, 2 minutes

The Kemenkes public database (infoalkes.kemkes.go.id) lets anyone verify a medical device license. The steps:

Open infoalkes.kemkes.go.id
Click the "Cari Alkes" menu in the top navigation
Fill in one of the fields:
- Registration Number (fastest — copy from the product label)
- Trade Name (to see all product variants)
- Registrant Name (to see all products from one manufacturer)
Click "Cari" and check the result

The result displays:

Full Registration Number
Trade name and manufacturer name
Device class (A, B, C, or D)
Issue date and expiry date
Status (Active / Inactive)
Registrant name and address

For BPOM products, use cekbpom.pom.go.id — similar interface and information.

What to verify against

Many procurement officers only check "exists in database = safe". That isn't enough. Check these 6 things match:

1. Product name exactly

"Hand Scrub 4%" on the label vs "Hand Wash 4%" in the database = not the same product. Every formulation difference requires its own license.

2. Manufacturer / license holder name

Check that the manufacturer on the label matches the database. Sometimes the product is sold via a distributor, but the license-holder remains the original manufacturer. Don't conflate them.

3. Device class matches the intended use

Indonesian medical device classes:

Class A — low risk (bandages, simple measurement tools)
Class B — medium-low risk (non-sterile single-use items, some intact-skin antiseptics)
Class C — medium-high risk (hospital surface disinfectants, surgical scrubs)
Class D — high risk (implants, ventilators)

OR/ICU disinfectants must be minimum Class C. If you receive a product claiming "for OR use" but with a Class A license — that mismatch can become an audit finding.

4. License expiry date

The registration is valid 5 years, then requires renewal. Check the expiry. Many products are sold while the license has been expired for months — vendors ignore it, procurement doesn't check.

5. "Active" status

Status can change to "Revoked" or "Suspended" because of post-market findings. Always verify the current status, not just the record's existence.

6. Specification detail (where available)

Some infoalkes entries show a brief spec (active ingredient, concentration). Match that against the vendor's PIS/TDS. A concentration mismatch = a different product sold under the wrong license.

Red flags often found during verification

The number looks valid but the format is odd. Standard Kemenkes NIE format: AKL (foreign device) or AKD (domestic device) + 11 digits. Example: AKL 20204020356. Anything else is not a Kemenkes NIE.
Valid number but for a different product. The vendor uses product A's license to sell product B, which has a different formulation. Verify the product name exactly.
A BPOM cosmetic license used for a hospital product. Professional medical hand wash, surgical scrub, clinical hand rub — all must have a Kemenkes license, not a BPOM one.
"Registration in process." No legal value. The product may only be sold after the NIE has been issued.
A foreign license used as a substitute for the Indonesian one. CE Mark, FDA, or ASEAN registration does not replace the Kemenkes requirement.
A halal certificate without a registration license. MUI halal is good, but doesn't replace a Kemenkes registration.
The license expiry is near (≤6 months). Caution — if the license isn't renewed, all products from a given batch become illegal.

Legal consequences of using an unregistered product

Actual consequences (from real cases at Indonesian hospitals):

Major audit finding from the Health Office — drops the hospital evaluation, requires a corrective plan within 3–6 months
KARS accreditation in the IPC working group may fail → re-accreditation delayed, the hospital's status is impacted
Administrative sanctions from the Provincial Health Office: written warning, temporary use suspension
Fines per Government Regulation 28/2024 on administrative sanctions in the health sector: IDR 25–500 million
Criminal charges if a patient is affected (e.g. severe dermatitis from an unregistered antiseptic) — Article 197 Health Law 36/2009: prison up to 15 years + fine up to IDR 1.5 billion

Important to understand: primary responsibility lies with the hospital that uses it, not the vendor selling it. "We didn't know" is not accepted — procurement is obligated to verify.

Questions to ask the vendor

Before signing a PO, send a formal email/letter requesting:

"Please attach a softcopy of the Kemenkes / BPOM license for every product offered."
"Please confirm the license remains active and will stay active throughout the contract period."
"Please provide a written guarantee that if the license is revoked/suspended during the contract, the vendor will provide an alternative product with a valid license at no additional cost."
"Please attach the manufacturer's Production Certificate and the distributor's Distribution Certificate."
"Please state each NIE's expiry date — we will plan a re-evaluation if it falls within the contract period."

A serious vendor will gladly send all of this within 1–2 business days. A vendor that stalls = a big red flag.

For a complete procurement guide

License verification is one of seven categories that must be checked during disinfectant procurement. For the complete picture, read Checklist for Disinfectant & Antiseptic Procurement at Hospitals covering compliance, technical specs, efficacy, MSDS, vendor qualification, commercial terms, and post-purchase service.

To understand the common disinfectant types and when to use each, see the 7 criteria for choosing a hospital disinfectant and the disinfectant vs antiseptic difference.

What Emguard provides

For every Emguard product in the medical-device category, we provide complete and transparent registration documentation:

A copy of the Kemenkes license with an NIE number you can verify directly at infoalkes.kemkes.go.id
Manufacturer's Production Certificate
Issue and expiry dates stated clearly in the procurement documents
6-month-ahead expiry notification — if a product's license will lapse during the contract, we tell you in advance and coordinate replacement with a newly-registered product
Written guarantee in the contract — if a license is revoked during the contract period, we provide an alternative with a valid license at no additional cost

For an Emguard license softcopy request or specific product verification, contact us via WhatsApp below. Our team responds within 1–2 business hours.

Summary

License verification is not a formality — it's fundamental legal protection and patient protection. The public database is free to access and takes 2 minutes per product. Check the product name, manufacturer, device class, expiry date, and active status. Ask the vendor for formal documentation at the start of procurement. Primary responsibility ultimately rests with the hospital using the product — prepare well, and audits become a smooth process, not a source of fear.