Indonesia Class A Medical Devices Halal Deadline Moved to 2028 — What Importers Should Do Now
1. Two regulators, not one: BPOM vs BPJPH
| Regulator | What it controls | Requirement |
|---|---|---|
| Ministry of Health (Kemenkes) | AKL (izin edar) market-authorisation for class A (low-risk) medical devices | AKL number — pre-existing, unchanged |
| 🔴 BPJPH (halal) | Halal product assurance — the new requirement landing on class A (low-risk) medical devices from the 2028 deadline | Halal certificate or non-halal mark |
The mistake importers make is treating halal as "just another BPOM step". They are two separate gates: a product can hold a valid Kemenkes AKL number yet still be non-compliant on halal from the 2028 deadline. Both must be in place before retail distribution.
2. Deadline moved: 2026 → 2028
| Date | Meaning | Basis |
|---|---|---|
| 17 Oct 2024 | Phase one — domestic medium/large food & beverage businesses in scope | PP 39/2021 Art.140 |
| 🔴 18 Oct 2026 | Original enforcement date — cancelled by the 16 Oct 2026 postponement announcement | PP 42/2024 (superseded) |
| 🔴 17 Oct 2028 | New transition deadline — class A medical devices, class A (low-risk) medical devices, chemicals, traditional medicines, supplements and imported goods must hold certificates by this date | PP 42/2024 amendment |
| 🔴 18 Oct 2028 | New enforcement — products without a certificate or non-halal mark are treated as non-compliant; e-commerce, customs and BPOM begin joint verification | BPJPH enforcement |
The postponement gives importers a two-year runway. The routes do not change: use the time to complete SIHALAL, or register an existing foreign certificate via SHLN.
3. Two routes for a compliant class A medical device
| Aspect | Full certification (SIHALAL) | Foreign-certificate registration (SHLN) |
|---|---|---|
| When it applies | No recognised foreign certificate, or the foreign body has an MRA but no authority for class A (low-risk) medical devices | The foreign certifier holds an MRA with BPJPH and its standards are accepted as equivalent |
| Timeline | Commonly 3–6 months (inspection, audit, lab testing) | Up to 20 working days |
| Who files | Through an Indonesian import unit or authorised representative | The Indonesian importer registers the foreign certificate |
Document mismatches — product names, ingredient lists or production addresses — are the most common cause of SHLN delay. The certificate must be apostilled, and the product HS code, letter of appointment and importer licence must be submitted.
4. The haram-ingredient case: non-halal labelling
| Item | Rule |
|---|---|
| Non-halal mark | A picture, logo or text placed on the packaging, part of the product or a specific location; easy to see and read, not easily erased |
| Haram ingredients | Must be printed in a different colour in the ingredient list |
| Alcohol | Medical device alcohol content is subject to specific thresholds; above the limit the product is treated as haram |
The non-halal label is not a loophole — it is a legally defined path for products that genuinely cannot be certified. Using it on a product that could be certified is a compliance risk.
5. Key questions
When does halal certification become mandatory for class A (low-risk) medical devices in Indonesia?
Originally set for 18 October 2026, the deadline was postponed to 2028 by an amendment to PP 42/2024 announced on 16 October 2026. Class A Medical Devices are part of phase two of the mandatory-halal rollout.
Is a Kemenkes AKL number the same as a halal certificate?
No. Kemenkes issues the AKL (izin edar) market-authorisation number covering safety and labelling; BPJPH issues halal certification. A product can hold a valid Kemenkes AKL yet still be non-compliant on halal from the 2028 deadline. Both are required.
What should I do now that the deadline has moved to 2028?
Use the two-year window to complete SIHALAL full certification (3–6 months), or register an existing foreign certificate via SHLN (up to 20 working days) if your certifier holds an MRA with BPJPH. Products containing haram ingredients still use the non-halal label.
Can a class A medical device with alcohol or animal-derived ingredients still be imported?
Yes, provided it is clearly marked non-halal and haram ingredients are printed in a different colour. Alcohol above permitted thresholds or porcine/animal derivatives make a product non-certifiable rather than bannable.
What happens to non-compliant class A (low-risk) medical devices after the 2028 deadline?
Administrative sanctions include written warnings, fines, certificate revocation and withdrawal of goods from circulation. E-commerce platforms, customs and BPOM begin joint verification of halal certificate numbers.
How long does an Indonesian halal certificate last for class A (low-risk) medical devices?
Under PP 42/2024 the certificate is valid indefinitely while ingredients and the production process are unchanged. Any change to ingredients, process or product development requires an update filing with BPJPH.
6. Official sources (traceable)
| Regulation / official entry | Status | What this page cites |
|---|---|---|
| Law 33/2014 (Halal Product Assurance) | 🟢 In force | Enabling law establishing BPJPH |
| PP 39/2021 | 🟢 In force | Phased framework, product groupings, original dates |
| PP 42/2024 | 🟢 In force | Phase-two date moved to 2028 by the amendment announced 16 Oct 2026 |
| BPJPH Regulation 4/2026 | 🟢 In force (5 Sep 2026) | Revoked by the 2028 postponement announcement |
Dates on this page reflect authoritative sources verifiable on 2026-10-18. The halal HS list and the MRA list update continuously — re-check the current version before shipping.
Related pages
Halal certification for imports (food & beverage, 17 Oct) BPOM class A (low-risk) medical devices import notification (NA) Food import: BPOM & halal SNI & BPOM certification overview Indonesia import compliance guide