This guide is for an Indonesian importer or AKL holder of sterile single-use devices, and the foreign manufacturer supplying it, deciding what each SKU needs on file before 18 October 2026. It does not cover the AKL registration itself, halal production systems, or fatwa procedure.
Which devices are inside the halal obligation at all?
Article 2(1) of Presidential Regulation No. 6 of 2023 (Perpres 6/2023) states the obligation broadly: medicines, biological products and medical devices that enter, circulate and are traded in Indonesia must be halal-certified 1 2. Read alone, that sentence supports the certify-everything reading that circulates in campaign material. Paragraphs (5) and (6) of the same article narrow it for devices (author's translation):
- Article 2(5): medical devices in paragraph (1) include in vitro reagents and calibrators, software, and materials used alone or in combination to prevent conception, disinfect medical devices or test specimens from the human body in vitro, and may contain a drug that does not achieve its principal action through pharmacological, immunological or metabolic means (termasuk reagen in vitro dan kalibrator, perangkat lunak, dan bahan atau material ...).
- Article 2(6): medical devices as referred to in paragraphs (1) and (5) are only those that originate from animals and/or contain animal elements (hanya bagi yang berasal dari hewan dan/atau mengandung unsur hewan).
The Ministry of Health's implementing regulation repeats the limit. Permenkes No. 3 of 2024 was issued to implement Articles 11(1) and 15(6) of the Perpres. Its Article 3(4) applies the halal manufacturing guideline only to devices that originate from animals and/or contain animal elements, and its Annex II states that the devices that must be halal-certified are those originating from and/or containing animal elements 4.
The staging dates now sit in a later instrument. Government Regulation No. 42 of 2024 (PP 42/2024), promulgated on 17 October 2024, revoked PP 39/2021 in Article 197. Article 196 kept the implementing regulations of PP 39/2021 in force insofar as they do not conflict with the new regulation 3. Perpres 6/2023 was issued to implement PP 39/2021 1, so it continues under that clause. PP 42/2024 Article 161(1)(g) names Class A medical devices without repeating the animal-origin qualifier, and BPJPH's 2026 category lists use the same unqualified wording 3 5. We found no provision of PP 42/2024 that removes the Perpres limit. The unqualified wording is still why importers keep hearing that every device needs a certificate, so the animal-origin evidence has to sit in the file rather than rely on the reader knowing Article 2(6).
The English-language advisories that rank for this question print the class years correctly. Andaman Medical's November 2024 note cites PP 42/2024 Article 161, and Emerhub's deadline table lists Classes A to C 12 13. Neither applies the animal-origin limit, and Emerhub states that imported products fall under the 17 October 2026 deadline without distinguishing device classes 13.
Neither the Perpres nor the Permenkes defines animal elements item by item. The materials a halal manufacturing system must control are listed broadly: raw materials including active substances and additives, and packaging, lubricants, grease or sanitizers in direct contact with the material or product 1 4. LPPOM, an Indonesian halal inspection body, has flagged plasticizers made from fat, glycerin, fatty-acid esters and magnesium stearate as animal derivatives that can appear in device components. It also lists sutures, heart valves, vascular grafts, hemostatic devices, bone grafts and wound dressings made from animal material 11. A plastic-and-metal device therefore clears the gate on an additive-level declaration, not on its appearance. The texts read here do not say whether a processing aid that does not remain in the finished device makes it contain animal elements. Record that as a question in the declaration rather than resolve it by assumption.
| Gate | Legal text | Question for the SKU | Evidence that answers it | Outcome |
|---|---|---|---|---|
| 1. Animal origin | Perpres 6/2023 Art. 2(6); Permenkes 3/2024 Art. 3(4) | Does the device originate from animals or contain animal elements, including additives, lubricants and primary packaging in direct contact? | Manufacturer's SKU-level material declaration naming the species and source of any animal-derived input | No: outside the device certificate duty. Yes: go to gate 2. |
| 2. Indonesian risk class | Perpres 6/2023 Art. 13; PP 42/2024 Art. 161(1)(g) to (i) | Which class does the Indonesian izin edar (AKL) record? | AKL record, checked on the Kemenkes public search | Class A staging ends 17 Oct 2026; B 17 Oct 2029; C 17 Oct 2034; D 17 Oct 2039. |
| 3. Certificate or statement | Perpres 6/2023 Arts. 14 to 16; Permenkes 3/2024 Art. 5 and Annex II | Is every animal input halal-sourced and the process halal, or is a material prohibited, not yet halal-sourced, or the process not yet halal? | Halal certificates for animal-derived inputs; source and slaughter statements; the AKL holder's statement with supporting documents | All halal: apply for a certificate or register a recognized foreign one. Otherwise: non-halal statement on the product marking. |
| Prerequisite | Perpres 6/2023 Art. 8 | Does the device hold a valid izin edar and meet good manufacturing practice under the applicable rules? | Active AKL; the quality-system evidence the AKL file relies on | A certificate application presupposes both. |
Source: Perpres 6/2023 Articles 2, 8 and 13 to 16; PP 42/2024 Article 161; Permenkes 3/2024 Article 3, Article 5 and Annex II. VEMERIX reading, 4 October 2026.
Run the gates per SKU, not per catalogue. A distributor with staplers, foam dressings and gels on one AKL list can get three different answers.
What do 17 and 18 October 2026 each mean?
They are two ends of one transition, not two competing deadlines. PP 42/2024 Article 161(1)(g) sets the staging period for Class A medical devices as running from 17 October 2021 until 17 October 2026 (dimulai dari tanggal 17 Oktober 2021 sampai dengan tanggal 17 Oktober 2026) 3. BPJPH describes the obligation as applying from 18 October 2026 (mulai 18 Oktober 2026) and lists Class A medical devices (alat kesehatan kelas risiko A) among the categories reached on that day 5. In practice, 17 October is the last day of the transition and 18 October the first day the obligation applies without it.
The date has been restated three times since June 2026. At a nationwide outreach event on 4 June 2026, the Head of BPJPH listed the categories and said the October 2026 stage extends the obligation to micro and small businesses and to imported products 5. Before Commission VIII of the House of Representatives on 10 June 2026, he said there is no postponement (Tidak ada penundaan Wajib Halal Oktober 2026) 6. On 15 September 2026 the acting Deputy II of the Presidential Staff Office told a cross-ministry coordination meeting that implementation is set for 18 October 2026. She stressed that imported products and raw materials must be ready from their countries of origin 7. The finance, trade and agriculture ministries and the quarantine agency attended 7, but none of these announcements describes a device-specific border procedure. Do not plan on one, and do not assume there is none.
Products already on the market are not cut off by the date alone. Article 18 of the Perpres lets medicines, biological products and devices that were not certified on 17 October 2021 continue to enter and circulate according to the staging for their product type, provided they hold the permits the law requires 1. That is why an animal-origin Class B, C or D device keeps circulating after 18 October 2026 without a certificate, and an animal-origin Class A device does not.
BPJPH's June announcement lists the administrative sanctions for breaches of the halal assurance rules: written warning, administrative fine, revocation of the halal certificate, and withdrawal of the product from circulation 5. BPJPH Regulation No. 2 of 2026, promulgated on 5 June 2026, sets the procedure. BPJPH's summary of it adds operational freezing and revocation of registration numbers, names failure to meet the certification obligation among the breaches, and describes staged sanctions with time to correct and an objection route to the Head of BPJPH 8. This guide relies on that summary rather than the regulation's text, and gives no fine amounts.
Which Indonesian risk class sets the year?
Article 13 of the Perpres stages the device obligation by risk class A to D, says the class division follows the prevailing rules, sends Classes A to C to the prevailing staging rules, and sets Class D until 17 October 2039 (sampai dengan tanggal 17 Oktober 2039), the same end date it gives biological products 1. The prevailing staging rules for Classes A to C are now PP 42/2024 Article 161(1)(g) to (i) 3.
| Indonesian class | Staging period ends | Obligation applies from | Legal basis | What an animal-origin SKU needs in October 2026 |
|---|---|---|---|---|
| A | 17 October 2026 | 18 October 2026, as BPJPH states | PP 42/2024 Art. 161(1)(g) | A halal certificate, or the non-halal statement on the marking where the material route applies |
| B | 17 October 2029 | The day after the staging period ends; BPJPH has not announced this stage | PP 42/2024 Art. 161(1)(h) | No certificate date yet; build the material file and settle the marking question now |
| C | 17 October 2034 | As for Class B | PP 42/2024 Art. 161(1)(i) | As for Class B |
| D | 17 October 2039 | As for Class B | Perpres 6/2023 Art. 13(6) | As for Class B |
Source: PP 42/2024 Article 161(1)(g) to (i); Perpres 6/2023 Article 13(6); BPJPH announcement of 4 June 2026. Read 4 October 2026.
The class is the one on the Indonesian izin edar, not the US, EU or Chinese class. Imported devices carry an AKL number written as KEMENKES RI AKL followed by eleven digits 9, and Kemenkes publishes a public search of marketing authorizations 10. Our register study of endovenous laser products shows why the record has to be read rather than inferred: Indonesian class C is not NMPA Class III, and a keyword hit is not the product on the licence.
The practical consequence is narrow. The October 2026 stage reaches animal-origin devices registered as Class A. An animal-origin device registered in a higher class has a later date, and a device outside the animal-origin gate has no device certificate date at all. Do not plan on a class you have not seen on the AKL.
When can a device circulate with marking instead of a certificate?
A device made from a prohibited material is not barred. Articles 14 to 16 of the Perpres put a statement on the product in place of a certificate (author's translation) 1:
- Article 14(1) and (3): medicines, biological products and devices originating from prohibited materials may circulate and be traded in Indonesia with the obligation to include a non-halal statement (Keterangan Tidak Halal). For devices, the statement is the name of the material in a different colour on the product marking (nama bahan dengan warna yang berbeda pada penandaan produk).
- Article 15(1), (3) and (4): products whose materials are not yet halal-sourced and/or whose manufacturing is not yet halal may circulate with information on the origin of the material until a halal material or method is found. For devices with materials not yet halal-sourced, the information is again the material name in a different colour. For halal materials made by a process that is not yet halal, it is the text berbahan halal dan dalam upaya memenuhi proses halal (made with halal materials and working to meet the halal process) on the product marking.
- Article 16: the non-halal statement is based on the business actor's own statement (pernyataan Pelaku Usaha), which must be provable with supporting documents.
Permenkes 3/2024 sets the format 4. The statement goes at least on the primary and the secondary packaging. Where that is physically impossible, as for large units or machines, it goes in the product brochure. It must not cover other information on the marking, must be easy to see and read, and must not be easy to erase, detach or damage. Annex II lists the animal materials treated as prohibited or not yet halal-sourced as carrion, blood, pig, and animals not slaughtered in accordance with sharia. For a halal material made by a not-yet-halal process, it gives the example text proses belum halal (process not yet halal) in a different colour.
That list changes the usual reading of bovine materials. Bovine collagen or gelatin from cattle not slaughtered in accordance with sharia is a material not yet halal-sourced. On the regulation's terms it takes the coloured statement until a halal-certified source is used. A porcine material cannot be certified halal and takes the statement for as long as it is used. The certificate route is open only when every animal-derived input is halal-sourced and the process is halal.
Two points are not settled by the texts read here. First, the Perpres stages the certificate obligation by class but prints no separate date for the non-halal statement. Do not assume a Class B device with a porcine component may wait until 2029 to change its marking; put the question to the AKL holder. Second, adding the statement changes approved labelling. Kemenkes' 2019 export-import guideline lists a change-notification letter among its services but does not say which route a non-halal statement uses 9. Ask the AKL holder how and when the labelling change will be filed.
For devices that do go for certification, Article 9(2) limits two of the product criteria to over-the-counter medicines and similar products and to devices whose use does not require a health professional. Those two are names or sensory profiles that point to something prohibited, and packaging and labelling consistent with Islamic principles 1. The other criteria, including halal materials and traceability, apply to professional-use devices as well.
Who must hold the certificate, and what goes in the shipment file?
The Perpres defines the business actor (Pelaku Usaha) as a person or entity conducting business in Indonesian territory, and that party's statement grounds a non-halal marking 1. For a product made abroad, PP 42/2024 Article 145 states that foreign products entering Indonesia must be halal-certified. Article 146 routes the application to BPJPH through the importer or an official representative domiciled in Indonesia 3. A foreign manufacturer does not file from abroad on its own. The device scope of Article 2(6) still decides which devices need a certificate at all.
There is a second route. Under Articles 147 and 148, a product whose halal certificate was issued by a foreign halal body with a BPJPH mutual-recognition agreement does not need a new application. The foreign certificate must be registered before the product circulates, and the importer or its official representative in Indonesia files the registration with a list of the goods and their HS codes 3. Emerhub describes the same route for foreign companies 13. Before choosing it, check that the foreign certifier's recognition covers the product scope.
Either route sits on top of the marketing authorization. Article 8 of the Perpres requires a device submitted for halal certification to meet safety, benefit and quality requirements evidenced by an izin edar, and good manufacturing practice under the applicable rules 1. Once a device is certified, Kemenkes' 2019 guideline describes a separate approval letter for adding the halal logo to labelling already approved under the izin edar. The request needs a valid izin edar with its approved labelling, a halal certificate naming the product, and the new labelling design 9.
| Document | Issued by | What it proves | Check before the shipment |
|---|---|---|---|
| 1. AKL record | Kemenkes | Izin edar and Indonesian risk class (Perpres Arts. 8 and 13) | Product name and class on the public search match the SKU being shipped |
| 2. Material declaration | Foreign manufacturer | Whether the device originates from or contains animal elements (Art. 2(6)) | Covers raw materials, additives, lubricants and primary packaging; names the species and source of anything animal-derived; states the slaughter status or halal certificate of animal inputs |
| 3. Halal certificate, or registration of a recognized foreign certificate | BPJPH | The certificate route (PP 42/2024 Arts. 146 to 148) | Product name matches; the foreign certifier's recognition covers the product scope |
| 4. Business actor's statement with supporting documents | Indonesian AKL holder | The basis for a non-halal statement (Perpres Art. 16) | Supporting documents trace back to the material declaration |
| 5. Labelling proof | AKL holder with the manufacturer | Placement of the statement (Permenkes 3/2024 Annex II) | Material name or process text in a different colour on primary and secondary packaging; labelling change filed as the AKL holder advises |
| 6. Quality-system evidence | Manufacturer and its certification body | Good manufacturing practice (Perpres Art. 8(b)) | The same evidence the AKL file relies on, current at shipment |
Source: Perpres 6/2023 Articles 2(6), 8, 13 and 16; PP 42/2024 Articles 146 to 148; Permenkes 3/2024 Annex II; Kemenkes export-import guideline. VEMERIX reading, 4 October 2026.
For a device outside gate 1, rows 1, 2 and 6 are the file. For an animal-origin Class B, C or D device, add a dated plan for row 3, or for rows 4 and 5. For an animal-origin Class A device, row 3, or rows 4 and 5, must be complete before 18 October 2026.
The manufacturer's main contribution is row 2. A useful declaration is SKU-specific, lists every component and additive, and says for each animal-derived input which species it comes from, who supplied it, and whether that supplier holds a halal certificate. A generic letter saying the company does not use animal materials does not answer the additive question that the inspection bodies raise.
Do gels, dressings and disinfectants follow the device schedule?
Only if they are registered as devices. PP 42/2024 Article 161 gives cosmetics and chemical products their own staging period ending 17 October 2026. Household health supplies (perbekalan kesehatan rumah tangga, PKRT) get the same date under the consumer-goods heading 3. Those categories are outside the Perpres device gate, which is written for medicines, biological products and devices. An imported PKRT is licensed with a PKL number, not an AKL 9.
- Wound dressings: a polyurethane foam or silicone contact layer still needs the additive-level declaration. Collagen, gelatin or animal-derived hyaluronic acid puts the dressing through gate 1, and the AKL then sets the year. The registered claim, not the material, usually decides the class, as our guide to why the claim, not the material, sets the regulatory class shows for other markets.
- Scar gels: a gel registered as a device follows the device gates, so the sources of glycerin and other excipients matter. A gel on a cosmetic route follows the cosmetics date instead. Cosmetic categories share the date, not the device schedule.
- Hypochlorous acid and other disinfectants: Article 2(5) of the Perpres includes materials used to disinfect medical devices 1. A product licensed as a PKRT or a chemical product follows its own category date. Check the licence before the label, and see when a disinfectant is not a medical device.
In each case the licence decides the schedule. The product's name does not.
What this guide does not settle
- The translations are the author's. No official English text was used. Quote the Indonesian terms when asking BPJPH, Kemenkes or a halal inspection body.
- Animal elements are not defined item by item. The processing-aid question in gate 1 is open.
- Perpres 6/2023 continues under PP 42/2024 Article 196 only insofar as it does not conflict with the newer regulation. A device-specific BPJPH or Kemenkes rule could change the reading, and this page will be rechecked against any such rule.
- BPJPH Regulation No. 2 of 2026 is described from BPJPH's own summary. The Kemenkes export-import guideline dates from 2019, before the Perpres, and is used only for the AKL number format and the halal-logo letter.
- Class and halal determinations sit with Kemenkes, BPJPH and the AKL holder. This page does not make them for any product, and it will be revised after 18 October 2026 to reflect what enforcement looks like in practice.
Where VEMERIX fits—and where due diligence still begins
VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care.
The public product pages list Chinese NMPA registrations and Chinese device classes. They do not state an Indonesian risk class, an AKL number, an animal-origin finding or a halal status for any product, and this guide does not assign one. The quality page describes ISO 9001 and ISO 13485 quality systems and ethylene-oxide sterilization at the Weihai plant.
For an Indonesian distributor screening a line from the product range, such as circumcision devices, laser fibers, NPWT dressings, scar and wound gels or HOCl products, the useful request is SKU-specific. Ask for a material declaration covering raw materials, additives, lubricants and primary packaging, with the source of anything animal-derived. Ask for the registration documents and quality-system certificates the AKL file will rely on. For gels, dressings and disinfectants, confirm which Indonesian category the AKL holder intends to register. The downloads page lists the registration documents and ISO files available on request, and the request itself goes through the contact page. For the registration evidence that comes before any halal question, see the registration evidence a distributor already requests before market entry.
Due diligence begins where this page stops. The Indonesian AKL holder decides the class it registers, signs any Article 16 statement, and carries the BPJPH filing. A manufacturer's declaration supports that file. It does not replace it.
Frequently asked questions
Does a plastic-and-metal device with no animal-derived material need a halal certificate by 17 October 2026?
Not under Perpres 6/2023 Article 2(6) and Permenkes 3/2024 Article 3(4), which limit the device certificate duty to devices that originate from animals or contain animal elements 1 4. The condition is that the declaration covers additives, lubricants and primary packaging, because plastics can carry fat-derived additives 11. Keep the declaration in the importer's file. BPJPH's category lists name Class A devices without the qualifier 5.
Is the deadline 17 or 18 October 2026?
Both, for different things. PP 42/2024 ends the Class A staging period on 17 October 2026, and BPJPH says the obligation applies from 18 October 2026 3 5. An animal-origin Class A device on the market from 18 October needs its certificate or its non-halal statement in place.
Our Class A dressing uses bovine collagen from a supplier without a halal certificate. Certificate or statement?
On the texts read here, the statement. Permenkes 3/2024 Annex II counts animals not slaughtered in accordance with sharia among materials not yet halal-sourced, and those devices circulate with the material name in a different colour on the primary and secondary packaging 4. Switching to a halal-certified collagen source opens the certificate route.
Does an animal-origin Class B device need anything on 18 October 2026?
No certificate is due until its staging period ends on 17 October 2029 3. The texts print no separate date for a non-halal statement, so settle with the AKL holder whether a prohibited-material component is marked now or later. Start the material file either way.
Can an overseas manufacturer apply directly to BPJPH?
No. PP 42/2024 Article 146 routes the application for a foreign product through the importer or an official representative domiciled in Indonesia. A certificate from a foreign halal body with a BPJPH recognition agreement is registered by the importer or representative before circulation 3. The Article 16 statement for a non-halal marking is the Indonesian business actor's 1.
Do wound gels, scar gels and disinfectants follow the medical device schedule?
Only when they are registered as devices. Cosmetics, chemical products and household health supplies each have their own staging period ending 17 October 2026, outside the Perpres device gate 3. Check whether the product holds an AKL, a PKL or a non-device registration before applying the device gates 9.