Halal Certification for Medical Devices: Timetable and the 2026 Deferral

1. Key takeaways

Indonesia’s halal certification regime for medical devices has a fixed legal direction, but the timetable for Class A devices was just postponed. The legal chain runs: UU 33/2014 (Halal Product Assurance Law) → PP 39/2021 (implementing rules, extending the mandatory scope from food and beverages to cosmetics, drugs, medical supplies and devices) → PP 42/2024 (phased timetable) → PP 40/2026 (latest amendment).

• What PP 40/2026 changed. PP 40/2026 was signed and entered into force on 14 October 2026 (State Gazette LN 2026 No.156) and amends PP 42/2024. A batch of halal obligations originally effective from 18 October 2026 is deferred to 18 October 2028. The deferred batch covers micro and small enterprises and imported food and beverages, traditional medicine and health supplements, cosmetics/chemical products/genetically engineered products, household consumer goods (clothing, headgear and accessories, household health products, household equipment/appliances, worship items, stationery, office equipment) and Class A (low-risk) medical devices. The amendment also revokes the pre-shipment verification provisions for imported products.
• What did not change. Three things. ① The obligation itself is not cancelled: the obligations set by the 2014 legislation, the certification and audit paths, and the validity of certificates already issued are unaffected. ② The timetable for subsequent batches stands under PP 42/2024: Class B devices 17 October 2029, Class C devices 17 October 2034 (industry estimate for Class D and biologics: 2039). ③ Non-halal labelling keeps advancing: under PerBPJPH 3/2026, the deadline for non-halal relabelling of products already on the market is 23 July 2027.
• Who does what. BPJPH (the Halal Product Assurance Organizing Agency) is the official certifying body (established 2017, formally began certification on 17 October 2019); MUI (the Indonesian Ulema Council) is responsible for halal fatwa rulings; LPH (Halal Inspection Agencies) conduct the audits. Certificates are issued by BPJPH and audited by LPH.
• Even animal-free products need a self-check. Whether certification is mandatory depends on product category and batch, but in practice companies should run an ingredient self-check: if no animal-derived or ethanol or other sensitive ingredients are confirmed, keep the materials on file; if animal-derived ingredients are present, evaluate the traceability/substitution route or the non-halal labelling route. Exemption assessment can follow Kepkaban BPJPH 301/2026 (effective from 31 August 2026, based on the nine criteria established in PP 42/2024, Article 70).

2. Legal basis

The statutory foundation is UU No. 33/2014, the Halal Product Assurance Law, which created the obligation. PP No. 39/2021 implemented it and extended the mandatory scope beyond food and beverages to cosmetics, drugs, medical supplies and devices. PP No. 42/2024 fixed the phased timetable (Articles 158, 161 and 162 are relevant). PP No. 40/2026, effective 14 October 2026 (LN 2026 No.156), is the latest amendment: it moves the Class A device obligations and the rest of the 18 October 2026 batch to 18 October 2028 and revokes the pre-shipment verification provisions for imported products. At the implementing level, PerBPJPH 2/2026 governs penalties, PerBPJPH 3/2026 sets the non-halal relabelling deadline of 23 July 2027, and Kepkaban BPJPH 301/2026 provides the exemption criteria from 31 August 2026. The BPJPH official site (bpjph.halal.go.id) is the primary reference. Because PP 40/2026 is a dynamic file, every provision must be re-verified clause by clause once the official text is published.

3. Expert insights

A deferral is not a pause button. Three reasons argue against waiting. First, halal determination has already begun to be linked to HS codes, which means some products can encounter problems at the customs stage, well before the registration or sales stage where companies expect halal questions to appear. Second, Indonesia’s demographic reality drives the policy: 80%-90% of the population is Muslim, the policy direction is unambiguous, and non-halal labelling is an inevitable requirement. Third, certification consumes time — ingredient traceability and LPH audit scheduling are the bottlenecks, and the closer to the deadline, the tighter the scheduling becomes for everyone who waited.

The deferral creates a two-year preparation window, and it should be used as preparation rather than as grace. The companies that benefit most from the postponement are those that use 2026-2028 to build the ingredient traceability table, lock down the animal-derived and ethanol risk points, and evaluate the cost of the two available paths — certification versus non-halal labelling — while audit slots are still available. Companies that treat the postponement as inaction will face the same queue, compressed, in 2028, with customs-side halal scrutiny already active in the meantime.

The unchanged timetable deserves as much attention as the changed one. For companies whose portfolios reach beyond Class A, the operative dates are still the PP 42/2024 schedule: Class B devices at 17 October 2029 and Class C devices at 17 October 2034, with the industry estimate for Class D and biologics at 2039. Meanwhile the non-halal relabelling deadline of 23 July 2027 under PerBPJPH 3/2026 is earlier than every certification deadline, so products that will travel the labelling route have the least time of all.

4. Practical recommendations

• Treat halal as a two-year preparation project, not a three-month sprint before the deadline. The deferral to 18 October 2028 is exactly the length of time the traceability work and audit scheduling realistically require.
• Build the full ingredient traceability table now. Map every component to its source and flag animal-derived and ethanol-related risk points while suppliers can still be questioned calmly.
• Evaluate both paths and their costs early. For products containing animal-derived ingredients, compare the traceability/substitution route against the non-halal labelling route before committing the portfolio.
• Run the exemption screen against Kepkaban BPJPH 301/2026. The nine criteria effective from 31 August 2026 determine which products can be assessed for exemption instead of certification.
• Track BPJPH follow-up rules for specific product categories. Category-specific provisions may arrive at any time before the deferred deadlines and can change the applicable path.

5. Verification checklist

• □ UU No. 33/2014 confirmed: Halal Product Assurance Law (verified 26 October 2026)
• □ PP No. 39/2021 confirmed: implementing rules and scope extension
• □ PP No. 42/2024 confirmed: phased timetable, Articles 158, 161, 162
• □ PP No. 40/2026 confirmed: effective 14 October 2026, LN 2026 No.156; Class A device obligations deferred to 18 October 2028
• □ PerBPJPH 2/2026 (penalties), PerBPJPH 3/2026 (non-halal relabelling deadline 23 July 2027), Kepkaban BPJPH 301/2026 (exemption criteria from 31 August 2026) confirmed
• □ BPJPH website checked: bpjph.halal.go.id; official text of PP 40/2026 pending verification, clause-by-clause re-check scheduled

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Indonesia. Our team prepares dossiers to ASEAN CSDT structure, manages AKL/AKL-I submissions with Kemenkes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com