Halal Certification for Class A Medical Devices: What Products Are Included?

Indonesia’s medical device industry is entering a crucial transition phase as the mandatory Halal certification for Class A medical devices (Alkes Kelas A) approaches its October 2026 deadline.
Under the Halal Product Assurance (JPH) regulation, all low-risk medical devices distributed in Indonesia must either be Halal-certified or clearly labeled as non-Halal by that date.

What Is a Class A Medical Device?

In Indonesia, medical devices are classified into four risk levels (A, B, C, D), where Class A denotes products that present the lowest risk based on the potential impact of their use on the patient.

The definition is formalized under the Ministry of Health Regulation (PERMENKES) No. 14 of 2021.

To qualify as an Alkes Class A Notification product, the device must meet three key criteria:

• Home-use: Can be used safely by the public without assistance from healthcare professionals.
  Example: walking cane, manual breast pump, or massage device.
• Non-sterile: The product is supplied without sterilization and does not require controlled temperature or humidity during storage.
  Example: adhesive bandages, gauze pads, or toothbrushes.
• Not a Diagnostic Device (Non-DIV): Products that do not analyze biological samples or require laboratory expertise.

List of Class A Medical Devices

Based on the official list from the Directorate General of Pharmaceutical and Medical Devices (Ditjen Farmalkes), below are examples of Class A devices subject to notification and thus included in the upcoming Halal certification mandate:

No.	Type of Product	Example
1	Arm sling	Arm fracture support, mitella
2	Body waste receptacle	Bedpan, urinal
3	Cane	Walking stick
4	Cane, crutch, and walker tips and pads	Pads for cane, crutch, and walker feet
5	Cold pack	Silica gel pouch for cold therapy
6	Crutch	Crutch
7	Dental floss	Dental cleaning thread
8	Elastic bandage	Elastic bandage
9	Flotation cushion	Cushion to prevent bedsores (decubitus)
10	Hernia support	Hernia support garment
11	Hot or cold disposable pack	Fever compress pack
12	Hot/cold water bottle	Hot/cold water bag for therapy
13	Ice bag	Ice bag for therapy
14	Limb orthosis	Arm, leg, or knee brace; corrective shoes
15	Manual breast pump	Manual breast pump
16	Manual toothbrush	Manual toothbrush
17	Mechanical wheelchair	Wheelchair
18	Mechanical walker	Four-legged walking aid
19	Medical adhesive tape and adhesive bandage	Adhesive plaster or bandage
20	Medical disposable bedding	Disposable underpad, bedsheet, or pillow cover
21	Medical insole	Heel insole
22	Moist heat pack	Silica gel pouch for heat therapy
23	Nipple shield	Nipple protector for breastfeeding
24	Nonresorbable gauze/sponge for external use	Non-sterile gauze or sponge for wound covering
25	Ophthalmic eye shield	Post-surgery eye shield (plastic/aluminum), non-sterile
26	OTC denture cleanser	Denture cleaner
27	Patient scale	Infant/adult weighing scale (for non-standing patients)
28	Protective garment for incontinence	Adult diaper
29	Scented or deodorized menstrual pad	Perfumed sanitary pad or pantyliner
30	Stand-on patient scale	Adult weighing scale
31	Teething ring	Solid teether without liquid content
32	Therapeutic massager	Massage chair or massage device
33	Truncal orthosis	Waist, neck, or lumbar support corset
34	Unscented menstrual pad	Non-perfumed sanitary pad or pantyliner

These items are typically home-use, non-sterile, and mass-produced, which makes them the first category of medical devices that must comply with Halal certification requirements by October 2026.

Labeling for Non-Halal Medical Devices

Medical Devices with Forbidden Ingredients

For medical devices containing forbidden ingredients or materials not sourced from halal sources, the non-halal label must display the name of the ingredient in a different color that is easily visible, readable, and resistant to removal, detachment, and damage. Forbidden materials include carrion, blood, pork, and/or animals slaughtered in a manner not compliant with Islamic law. An example of how to label this information is as follows:

• In Indonesia: “Bahan tidak halal”
• In English: “Non-halal ingredients”

Medical Devices with Halal Ingredients but Non-Halal Processes

For medical devices made from halal ingredients but manufactured using non-halal processes, the non-halal label must indicate the origin of the materials with the ingredient name in a different color that is easily visible, readable, and resistant to removal, detachment, and damage. Such devices are made with materials that have halal certification but involve the use or contact with forbidden materials during the manufacturing process. An example of how to label this information is as follows:

In English: “Process not halal yet”

In Indonesia: “Proses belum halal”

Reference:

Regulation of the Minister of Health of the Republic of Indonesia Number 3 of 2024

Key Takeaway

By October 2026, all Class A medical devices distributed in Indonesia must have Halal certification or be labeled accordingly.
The Alkes Kelas A list — including items such as toothbrushes, bandages, breast pumps, and massage devices — represents the primary group affected by this regulation.
Companies are strongly advised to begin their Halal compliance preparation now to avoid disruption in market access once the rule takes effect.

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