INDONESIA · MEDICAL DEVICES

Indonesia Medical Device Halal Certification: Class A Deferred to 2028 – How Should Manufacturers Prepare?

Indonesia’s PP 40/2026 extends the halal certification phase-in period for Class A medical devices from 17 October 2026 to 17 October 2028. The phase-in periods for Class B and C stay at 17 October 2029 and 17 October 2034; Class D runs to 17 October 2039 under the 2023 Presidential Regulation. (Sources: BPJPH timeline explanation; Perpres 6/2023, Article 13)

For medical device and IVD exporters, the first question is whether a product falls within the mandatory certification scope at all; scheduling by risk class comes second. The assessment has to be made at the level of the specific model, its materials, how it contacts the body and how it is used. Different products under the same brand, or in the same registration grouping, should each be assessed.

Which medical devices are covered? Start with the criteria in Guideline 373

BPJPH Decree 373/2026, the guideline for the halal product assurance system (SJPH) for medical devices, sets out in Chapter II Section A and the Appendix II decision tree that a device falls within mandatory certification only if it meets all of the following conditions. Neither “contains animal-derived material” nor the risk class is enough on its own. (Source: Guideline 373, pp. 7 and 18)

The guideline exempts devices that do not meet these conditions: no further material/process assessment is needed, and no additional labelling or reporting. The exemption applies to the halal regime only; product registration and other market obligations still apply under their own rules. Settle applicability first, and organise the detailed material review only once a device is confirmed to be in scope. (Source: Guideline 373, Chapter II Section A, item 5)

Containing alcohol does not mean a product has been judged “non-halal”. Composition is one factor in the scope assessment; the actual source, manufacturing process and applicable requirements still need to be verified. Where the intended use or the religious-use condition is unclear, submit the specific question and product description to the relevant authority rather than widening or narrowing the scope yourself.

When do Class A, B, C and D phase-in periods end?

The table shows the end of the phase-in period for devices in scope; Guideline 373 expresses this as applying “from the following day” (18 October). Record the date and legal source for each risk class separately.

Guideline 373 was issued on 12 October 2026 and its main text still states that Class A applies from 18 October 2026; PP 40, promulgated on 14 October, then changed the phase-in period. Use the dates in PP 40 and BPJPH’s subsequent explanation, not the timetable in the earlier guideline. (Sources: PP 40 text; BPJPH explanation)

IVD manufacturers should assess analysers, reagents and collection devices separately

A diagnostic system may include an analyser, reagents, calibrators, controls and specimen-collection devices. List each component’s intended use, whether it enters or directly contacts the body, and the source of its materials, then check them against the conditions. Knowing only that a reagent contains an enzyme, or that an instrument housing is plastic, is not enough to assess the whole system.

Illustrative scenario: a kit consists of an in vitro reader, reagents and a specimen-collection device that directly contacts the body. The manufacturer should describe how each part is used, verify the sources of the reagents and related materials, and then define the configurations to be supplied and the certification scope. The reader’s material statement cannot stand in for the other components, and an animal-derived reagent does not mean the other conditions can be skipped. The scenario illustrates the method only; it does not mean any particular product is exempt or must be certified.

How products are grouped for registration and which products and sites a halal certificate covers are separate questions. List every configuration, model and factory to be supplied, and have the scope confirmed through the relevant procedure. For product registration, see our Indonesia medical device registration guide.

Once a device is in scope, how do you turn existing records into usable evidence?

Chapter III of Guideline 373 brings material and process controls into the SJPH and distinguishes materials that need halal evidence, materials exempted by law, and materials supported by other documentation. Existing ISO 13485 records provide a traceability base, but halal-specific evidence and controls still need to be added. (Source: Guideline 373, Chapter III)

The approach below is MediPass’s suggested way to organise information between manufacturers and suppliers; it is not an official submission form.

The output of this step should answer: which model uses which material, who makes it, what the evidence covers, and which records must be updated if a supplier changes. That keeps materials, certificates and the versions actually supplied aligned.

Handle non-halal materials and not-yet-halal processes separately

A device that is within mandatory certification scope but whose materials or process do not yet meet halal requirements may still be marketed in Indonesia, provided it carries a non-halal statement (keterangan tidak halal) as required. (Source: Guideline 373, Chapter II Section A, item 4) The statement differs according to the cause:

• Material from a prohibited source, or not yet from a halal source: the material name is shown in a different colour on the product labelling.
• Halal material, but the manufacturing process is not yet halal: the labelling states that the product is made from halal material and is working towards a halal process.

(Sources: Perpres 6/2023, Articles 14–15; Permenkes 3/2024, Article 5 and Appendix II)

So first establish whether the issue lies in the material source or the manufacturing process, then check the corresponding labelling and declarations. Do not label a product “non-halal” across the board while the source is still unknown. The device’s marketing authorisation still has to be obtained; halal information on the label does not replace product registration.

Can a foreign halal certificate be used in Indonesia? Check three levels

First check whether the issuing body is a foreign halal institution (LHLN) recognised by BPJPH, and the scope of that recognition. Then check the products, manufacturing sites and validity covered by the specific certificate. Finally, confirm how the certificate is to be used in Indonesia under BPJPH’s current requirements. A cooperation agreement with the body does not mean every certificate it issues covers your product, and a certificate for a raw material is not recognition of the finished device. (Source: BPJPH statement on foreign certificates and mutual recognition)

Note also that Article II of PP 40/2026 revoked the earlier specific rules on conformity assurance for foreign halal products. This does not remove the registration of foreign certificates in Indonesia; follow BPJPH’s current procedure.

Manufacturers can put the certificate number, issuing body, certified products, manufacturing site and models to be sold into a single matrix, marking each line “matched”, “more documents needed” or “confirm with the relevant body”. This is far more useful to a local partner than a scanned certificate on its own.