Izin edar notifikasi is a simplified market authorization pathway from Indonesia's Ministry of Health. It covers certain Class A medical devices, along with Class 1 and 2 household health products (PKRT).
Notification approval takes around 12 working days, where a standard registration takes considerably longer. The trade-off, however, is that eligibility is tightly drawn. For instance, a sterile or powered version of an otherwise eligible product does not qualify for notification approval.
In this article, we will discuss the essentials of notification approval for Class A Medical Devices in Indonesia, including qualification criteria and requirements.
| Notification | Regular registration | |
|---|---|---|
| Product types | Specific Class A home-use devices that are non-sterile and not IVD, plus PKRT Class 1 and 2 | Standard Class A devices, and all Class B, C, and D devices |
| Technical documentation | Product specifications and labelling artwork | Full evaluation dossier covering quality, safety, and efficacy |
| Performance evidence | Not required | Clinical or performance testing data, and risk analysis |
| Sterility documentation | Not applicable, as sterile products are excluded | Sterilisation process validation and sterility test results, where the product is sterile |
| Dossier format | Simplified submission | ASEAN Common Submission Dossier Template |
| Review period | Around 12 working days | 15 to 45 working days depending on class, before any deficiency stage |
The documentation is the most time taking part. A standard registration requires a full technical dossier in the ASEAN Common Submission Dossier Template (CSDT), covering safety and performance evidence, risk analysis, and test data. Collecting that from your manufacturer usually takes longer than the review itself.
A notification asks for your product specifications and labelling artwork instead. You still need the supporting certificates listed in the process section below, but not the evidence package.
Which Class A Devices Qualify for Notification
Class A is Indonesia's lowest risk class for medical devices. However, being Class A does not on its own make a product eligible for notification. To use the notification approval pathway, your product has to meet all three of the following criteria:
- It must be for home use: The device has to be usable by the general public without specialized skills and without assistance from a healthcare professional. Walking sticks, massagers, and manual breast pumps are typical examples.
- It must be non-sterile: The device is supplied in a non-sterile condition, meaning the manufacturing process does not involve sterilization and the product is not packaged as sterile. Sterile devices require additional documentation, including sterilization process validation and sterility test results, which is why they fall outside the simplified pathway. Non-sterile devices also avoid the temperature and humidity controlled storage conditions that sterile products need.
- It must not be an in vitro diagnostic device: IVD products are sensitive to temperature and humidity, and their performance depends on tightly controlled conditions. Moreover, operating them generally requires professional expertise. Clinical laboratory equipment such as pipettes and analyzers, along with reagents and test kits, all fall into this category.
| Criterion | Requirement | Examples |
|---|---|---|
| Home use | Usable by the general public without specialised skills or professional assistance | Walking aids, massage devices, manual breast pumps |
| Non-sterile | Not sterilised during manufacturing and not packaged as a sterile product | Non-sterile gauze, non-sterile eye shields |
| Not an IVD | Not classified as an in vitro diagnostic device | Excludes pipettes, analysers, reagents, test kits |
A device has to meet all three. Missing any one of them sends the product to standard Class A registration or, in some cases, to a higher risk class altogether.
Eligibility Summary: Class A medical device should meet all three criteria: HOME USE + NON-STERILE + NOT AN IVD
Class A Medical Devices Eligible for Notification
| No. | Product type | Examples |
|---|---|---|
| 1 | Arm sling | Arm fracture support, triangular bandage (mitella) |
| 2 | Body waste receptacle | Bedpan, urinal |
| 3 | Cane | Walking stick |
| 4 | Cane, crutch, and walker tips and pads | Rubber tips and pads |
| 5 | Cold pack | Silica gel pack for cold therapy |
| 6 | Crutch | Crutches |
| 7 | Dental floss | Interdental cleaning floss |
| 8 | Elastic bandage | Elastic compression bandage |
| 9 | Flotation cushion | Cushion for pressure ulcer prevention |
| 10 | Hernia support | Hernia brief or belt |
| 11 | Hot or cold disposable pack | Fever cooling patch or compress |
| 12 | Hot or cold water bottle | Hot or cold water bag for therapy |
| 13 | Ice bag | Ice bag for therapy |
| 14 | Limb orthosis | Hand, foot, and knee braces, corrective shoes |
| 15 | Manual breast pump | Manual breast pump |
| 16 | Manual toothbrush | Manual toothbrush |
| 17 | Mechanical wheelchair | Standard wheelchair |
| 18 | Mechanical walker | Four-legged walking aid |
| 19 | Medical adhesive tape and adhesive bandage | Adhesive plaster or tape |
| 20 | Medical disposable bedding | Disposable underpads, bedsheets, pillowcases |
| 21 | Medical insole | Heel or arch insole |
| 22 | Moist heat pack | Silica gel pack for warm therapy |
| 23 | Nipple shield | Nipple protector for breastfeeding |
| 24 | Non-resorbable gauze or sponge for external use | Non-sterile wound coverage gauze |
| 25 | Ophthalmic eye shield | Post-surgery eye shield, non-sterile |
| 26 | OTC denture cleanser | Denture cleanser |
| 27 | Patient scale | Baby scale, scale for patients unable to stand |
| 28 | Protective garment for incontinence | Adult diaper |
| 29 | Scented or deodorised menstrual pad | Perfumed sanitary pads and pantyliners |
| 30 | Stand-on patient scale | Adult standing scale |
| 31 | Teething ring | Solid teether without liquid filling |
| 32 | Therapeutic massager | Massage chair, handheld massager |
| 33 | Truncal orthosis | Waist, neck, and lumbar supports |
| 34 | Unscented menstrual pad | Non-perfumed sanitary pads and pantyliners |
Case Assessments: Is Your Product Eligible for Notification?
Most of the queries our regulatory team receives concern products that sit close to the line. The device type appears on the list above, but the particular version a client wants to bring in does not qualify.
Below are some of the cases that most often cause confusion.
| Product | Why it does not qualify | Version that does qualify |
|---|---|---|
| Sterile gauze pads | Sterile, so it fails the non-sterile criterion | Non-resorbable gauze and sponge for external use, supplied non-sterile |
| Sterile eye pad or eye shield | Sterile, requiring sterilisation validation and sterility test results | Ophthalmic eye shield in plastic or aluminium, supplied non-sterile |
| Water-filled teether | Liquid filling places it in Class B | Solid teething ring with no liquid filling |
| Electric breast pump | Powered, placing it in Class B | Manual breast pump |
| Motorised wheelchair | Powered drive carries electrical and safety risks, placing it in Class B | Mechanical wheelchair |
| Clinical laboratory pipette | Classified as in vitro diagnostic equipment | None. Standard Class A registration applies |
| Plaster of Paris bandage B.P. | Commonly assumed to fall under medical adhesive tape and adhesive bandage, item 19 on the list above. Its actual product type is a prosthetic and orthotic accessory | None. That product type does not appear on the notification list. |
Notice what most of these have in common. Sterility, liquid filling, a power source, or a diagnostic function each take a product out of the pathway, even where the plain version of the same device is eligible for notification based approval pathway.
If your product does not qualify for notification approval, it goes through standard registration. Our guide to medical device registration in Indonesia covers the requirements and process in detail.
What You Still Need for a Notification Product
The simplified pathway reduces the technical documentation, but it does not remove the other requirements that apply to any device sold in Indonesia.
1. A local license holder
Foreign manufacturers cannot hold an izin edar directly. The registration sits with an Indonesian medical device distributor (DAK), holding a valid medical device distribution license, the izin distribusi alat kesehatan (IDAK). That company becomes your product license holder.
Under Permenkes 62/2017, only one distributor may hold the authorization for a given trade name at a time.
2. Distribution certification
Your license holder needs certification in good distribution practice for medical devices, the cara distribusi alat kesehatan yang baik (CDAKB). Manufacturers hold the equivalent production standard, cara pembuatan alat kesehatan yang baik (CPAKB). Both are prerequisites in the OSS system.
3. Compliant labelling
Labels have to carry the product name, the izin edar number, the manufacturer and importer details, and traceability data, in Bahasa Indonesia. Our guide to medical device labelling sets out the full checklist.
4. Halal certification by 17 October 2026
Article 161 of Government Regulation No. 42 of 2024 requires Class A risk medical devices to hold halal certification by 17 October 2026. Higher risk classes follow later, with Class B due by 17 October 2029, Class C by 17 October 2034, and Class D along with biological products by 17 October 2039.
Halal certification in Indonesia is issued by BPJPH, the halal product assurance agency, following inspection by an accredited halal inspection body. Products containing animal-derived materials that are not certified must carry a non-halal label.
BPJPH has confirmed there will be no further extension. And sanctions for non-compliance start from written warnings and administrative fines to withdrawal of products from circulation.
It's strongly recommended to assess your materials now rather than after your notification is approved, since collagen, gelatin, and cleaning agents used in manufacturing are the components that most often need substituting or certifying.
Timeline, Validity, and Renewal
A notification is reviewed in around 12 working days, against roughly 45 for a standard Class A registration once a deficiency notice is factored in.
Applications go through the Ministry of Health's Regalkes system under your license holder's account.
If the Ministry finds a deficiency in your application, you get one opportunity to answer it. If you miss the window, or respond incompletely, the Directorate General issues a letter of rejection rather than a second request. Which means starting again with a fresh application.
Once approved, your izin edar is valid for up to five years. However, if your license holder is an appointed sole agent or distributor, it instead runs for the length of that appointment, which Permenkes 62/2017 requires to be between two and five years. Products made under an OEM arrangement are capped at three years.
You can apply for renewal nine months before expiry. At this time, you must also file your production or distribution report through e-report first. The renewal cannot be processed without this report.
Registering Your Medical Devices with Emerhub
Emerhub acts as your local product license holder in Indonesia, which means you can register and sell your devices without setting up an Indonesian entity or appointing a third-party distributor.
Our regulatory team handles the entire product registration process on your behalf from product assessment to post approval compliance.
Tell our Jakarta team what you plan to bring into Indonesia, and we will tell you which products qualify for notification and what the process involves.
Official Sources
- Regalkes, the Ministry of Health portal for medical device and PKRT product licensing
- Permenkes No. 62 of 2017, on product licensing for medical devices, IVD medical devices, and PKRT. An official English translation is published on Regalkes.
- Permenkes No. 11 of 2025, on business activity and product standards for risk-based licensing in the health subsector, issued under PP No. 28 of 2025
- Law No. 33 of 2014 on halal product assurance, Presidential Regulation No. 6 of 2023 on halal certification for medicines, biological products, and medical devices, and PP No. 42 of 2024, whose Article 161 sets the phased deadline.
- BPJPH, the halal product assurance agency
Frequently asked questions
What is izin edar notifikasi?
It is a simplified market authorization pathway for low-risk products, covering certain Class A medical devices and Class 1 and 2 household health products. It requires lighter documentation than standard registration and is processed considerably faster, while producing the same izin edar.
Which Class A devices qualify for notification?
Only devices that meet all three criteria: intended for home use without specialized skills, supplied non-sterile, and not classified as in vitro diagnostic devices. The device type also has to appear on the Ministry of Health's eligible product list.
Can a foreign manufacturer hold the registration?
No. The izin edar is held by an Indonesian entity with a valid IDAK distribution license, which acts as the product license holder. Only one entity can hold the authorization for a given trade name at a time.
Can I change my Indonesian distributor after registering?
Only once the product license expires, or with your existing distributor's agreement, which in practice means a no-objection letter from them. Since that is the party you are trying to leave, transfers are difficult. Holding the registration with an independent license holder from the outset avoids the problem.
How many chances do I get to fix a deficiency in my application?
Permenkes 62/2017 gives you a single window to supply what is missing, 10 working days for Class A, B, and C products and 15 for Class D. Miss it or respond incompletely and the Directorate General issues a rejection letter, so you begin again with a fresh application.