Medical device registration in Indonesia
All medical devices, whether manufactured domestically in Indonesia or imported, must be registered with the Ministry of Health via the Online Medical Device Registration platform (hereafter called the Kemenkes system).
Who can register a medical device in Indonesia?
In order to register a medical device in Indonesia, a company must first obtain a IDAK (Izin Distribusi Alat Kesehatan) or Medical Device Distribution License (MDDL) otherwise known as a distributor license. The IDAK/MDDC can be applied for via the online licensing platform and once approved it will be issued through Online Single Submission (OSS) website. Please note that IDAK is the new name for the IPAK (Izin Penyalur Alat Kesehatan) and SDAK (Sertifikat Distribusi Alat Kesehatan). All existing distributors who want to request a modification of their IPAK will receive an IDAK. The main difference between the SDAK and the IPAK is the validity which is limited to 5 (five) years for an IDAK and SDAK whilst no there is no time limit on the validity of an IPAK.
Currently, only local (Indonesian) companies can apply for the IDAK/MDDL. Foreign manufacturers, therefore, have three (3) possibilities to obtain an IDAK/MDDL and so register their medical device in Indonesia:
Set up a legal subsidiary entity
to register the medical devices. Please note that a foreign-owned company is required to have total investment value greater than IDR10 billion (US$760,000) according to regulation BKPM 14/2015 and that the establishment process can be complex and time consuming.
Appoint a local distributor
who has an IDAK/MDDL or SDAK/MDDC to register the medical devices
Appoint an independent third party
1a) such as Andaman Medical to register the medical devices directly on behalf of the foreign manufacturer. Andaman Medical is a fully certified SDAK/MDDC distributor license holder and acts directly on behalf of foreign manufacturers. See below for more on how we can help. 1b) such as Andaman Medical to register medical devices on behalf of a local distributor who has an IDAK/MDDL or SDAK/MDDC. This option is useful in case your preferred local distributor does not have an internal regulatory affairs service which can prove difficult if you have future change notifications to make. See below for more on how we can help. Once you have chosen your route-to-market and have ensured that the local company has the required and valid IDAK/MDDL or SDAK/MDDC, the holder of this distributor license may then proceed to register medical devices with the Ministry of Health.
Once you have chosen your route-to-market and have ensured that the local company has the required and valid SDAK/MDDC, the holder of this distributor license may then proceed to register medical devices with the Ministry of Health.
As a signatory to the AMDD (ASEAN Medical Device Directive), Indonesia has integrated the ASEAN Common Submission Dossier Template (CSDT) into its online registration system (the Kemenkes platform).
Once the medical device has been registered via the Kemenkes platform, the Indonesian Ministry of Health will issue a Distribution Approval Number or NIE (Nomor Izin Edar) otherwise known as the Product Approval License.
The company which receives the NIE or Product Approval License is the Product License Holder. Please note that one medical device can only registered by one distributor license holder at a time. Multiple registrations of medical devices with different distributor license holders are not allowed in Indonesia and neither are license transfers. For manufacturers, it can prove difficult and costly should the existing product license holder not wish to relinquish their right to distribute the product in Indonesia. Hence the advantage of appointing an independent third party as the Product License Holder.
Classification of medical devices in Indonesia
There are three overriding product classifications in Indonesia:
- Medical Devices (Alat Kesehatan): which includes instruments, apparatus, machines and/or implants that do not contain drugs used to prevent, diagnose, cure and alleviate diseases, treat sick people, restore health to humans, and/or form structures and improve bodily functions.
- In vitro Diagnostics (Diagnostik in Vitro): which includes any reagents, reagent products, calibrators, control materials, kits, instruments, apparatus, equipment or systems.
- Household Health Supplies (Perbekalan Kesehatan Rumah Tangga or PKRT): which includes a tool, material, or mixture of materials for maintenance and care for human health, intended for use in households and public facilities.
Please note: in this webpage we will use the term medical devices to include medical devices as well as in-vitro diagnostics and household health supplies.
Medical devices in Indonesia are classified in terms of risk in accordance with the ASEAN Medical Device Directive (AMDD), which lists 4 classes:
Class A
Low Risk
Class B
Low to Moderate Risk
Class C
Moderate to High Risk
Class D
High Risk
PKRT in Indonesia are classified in terms of risk, which lists 3 classes:
Class 1
Low Risk
Class 2
Moderate Risk
Class 3
High Risk
The medical device risk class determines the necessary documentary requirements for registration. The higher the class of medical device, the more documentary information is required for submission in order to register.
Medical device grouping in Indonesia
Medical Devices and IVDs can be grouped and registered as one application in order to obtain one Product Approval License. Please note that the Ministry of Health has issued the following guidelines though they have not yet been implemented (as of March 2021). Groupings are allowed if the following conditions are met:
- The products have the same intended use.
- The products are used in combination to achieve the same intended use.
- There is sufficient similarity in the products that allows for simplification of approval license.
The grouping categories are as follows:
Single
Family
System
IVD Test Kit
IVD System
Group
The registration process
All new medical devices, IVDs and household health supplies (PKRT) product registrations must be login first through oss.go.id system to get the License ID then submitted online all the requirements via the Kemenkes platform. The filing of applications for medical device product registrations shall follow the guidelines stated in Regulation No. 62 of 2017.
Once the necessary documentation has been uploaded according to the product’s risk class, the registrant has only 7 calendar days to process payment. Each distributor license holder has a maximum number of submissions that can be made in any 1 (one) working day:
- 2 (two) new product registrations applications per working day
- 5 (five) renewal and/or change notification applications per working day
Once payment is received, the Indonesian Ministry of Health will start to evaluate the submission. Should all documentation meet the requirements, then the Ministry of Health will issue the NIE or Product Approval License otherwise known as the marketing authorization. However, the Ministry of Health may consider that the documentation submitted does not meet the requirements and thereby request additional documentation. At this stage, the Ministry of Health in Indonesia will evaluate the submission again, and if successful a marketing authorization will be issued or if not, then the submission will be rejected.
What documents are required to register medical devices in Indonesia?
Various documentation is required to register a medical device in Indonesia and the list differs for in-vitro diagnostics which differs again for household health supplies. The languages accepted for submission are Bahasa (Indonesian) and English. In general, you will be required to submit a device description, any pre-clinical studies, device labelling, instructions for use, a risk analysis and of course any existing regulatory approvals or market authorisations already obtained.
Certain products require additional documentation such as those which contain or transmit radiation. And some specific products must undergo local testing in an accredited laboratory in Indonesia.
Typical fees and timelines (biaya dan timeline)
A fee is payable for each submission for new medical device registrations, renewals or change notifications. This is a non-tax fee. The Ministry of Health will raise the fee invoice automatically upon submission to the Kemenkes platform. Payment must be made within 7 (seven) calendar days. For whatever reason if payment is not processed within the deadline, the submission will expire, and a new submission will be required
Previously, new medical device registrations could take anything between 6 (six) to 9 (nine) months, however this has become shorter since regulation no. 62 of 2017 has been applied (effective from 12 January 2018). The general timeline to register new medical devices is 1 (one) to 2 (two) months depending on the class of the medical device.
Should any additional documentation be required to be submitted, then the Indonesian Ministry of Health will allow 10-15working days to provide/submit the additional data. The Ministry of Health will reevaluate the submission within a period of 10 working days. There is no fee for submitting extra documents.
For registration renewals the general timeline is 34 (thirty-four) working days. These are maximum total timelines should additional data be required.
Indonesia’s Ministry of Health has announced that it has simplified registration for certain Class A medical devices, and Classes 1 and 2 of household health supplies (PKRT). Certain class A medical devices are devices that are for home use, can be used independently without requiring special expertise of health workers, not sterile medical devices, and not In Vitro Diagnostics medical device.
The simplified registration takes a maximum of 36 working days and if no additional supporting documentation is required, an application can be processed in just 16 days.
Distribution Permit Notification is only applicable for the following products:
Class A medical devices:
- Arm sling
- Body waste receptacle
- Cane
- Cane, crutch and walker tips and pads
- Cold pack
- Crutch
- Dental floss
- Elastic bandage
- Floatation cushion
- Hernia support
- Hot or cold disposable pack
- Hot/cold water bottle
- Ice bag
- Limb orthosis
- Manual breast pump
- Manual toothbrush
- Mechanical wheelchair
- Mechanical walker
- Medical adhesive tape and adhesive bandage
- Medical disposable bedding
- Medical insole
- Moist heat pack
- Nipple shield
- Non-resorbable gauze/sponge for external use
- Ophthalmic eye shield
- OTC Denture cleanser
- Patient scale
- Protective garment for incontinence
- Scented or scented deodorized menstrual pad
- Stand-on patient scale
- Teething ring
- Therapeutic massager
- Truncal orthosis
- Unscented menstrual pad
Class 1 household health products:
- Tissue and cotton
Class 2 household health products:
- Laundry Preparation
- Cleaner
- Baby and mother care products
- Antiseptic and disinfectant
- Fragrance
For Medical Device and IVD new registrations
| Class | Fee | Timeline |
|---|---|---|
| Class A | IDR 1,500,000 | Maximum of working 45 days |
| Class B and Class C | IDR 3,000,000 | Maximum of 60 days |
| Class D | IDR 5,000,000 | Maximum of 80 days |
For Medical Device and IVD renewals
| Class | Fee | Timeline |
|---|---|---|
| Class A | IDR 500,000 | Maximum of working 34 days |
| Class B, C and D | IDR 1,000,000 |
For Medical Device and IVD change notification
| Class | Fee | Timeline |
|---|---|---|
| Class A | IDR 500,000 | Maximum of working 40 days |
| Class B, C and D | IDR 1,000,000 |
For Medical Device and IVD renewal & change notification submitted together
| Class | Fee | Timeline |
|---|---|---|
| Class A | IDR 1,000,000 | Maximum of working 40 days |
| Class B, C and D | IDR 1,500,000 |
For PKRT new registrations
| Class | Fee | Timeline |
|---|---|---|
| Class 1 | IDR 1,000,000 | Maximum of working 45 days |
| Class 2 | IDR 2,000,000 | Maximum of 60 days |
| Class 3 | IDR 3,000,000 | Maximum of 75 days |
For PKRT renewals
| Class | Fee | Timeline |
|---|---|---|
| Class 1 | IDR 500,000 | Maximum of working 34 days |
| Class 2 and 3 | IDR 1,000,000 |
For PKRT change notification
| Class | Fee | Timeline |
|---|---|---|
| Class 1 | IDR 500,000 | Maximum of working 40 days |
| Class 2 and 3 | IDR 1,000,000 |
For PKRT renewal & change notification submitted together
| Class | Fee | Timeline |
|---|---|---|
| Class 1 | IDR 1,000,000 | Maximum of working 40 days |
| Class 2 and 3 | IDR 1,500,000 |
How Andaman Medical can help:
Andaman Medical is a regulatory affairs and market access consultancy that specializes in the registration, authorized representation, importation and master distribution of medical device and in-vitro diagnostics in Southeast Asia.
Our in-house team of local, experienced regulatory affairs specialists provide unrivalled assistance to medical device manufacturers and distributors alike who benefit from accessing real, on-the-ground expertise.
Our registration services include:
- Standard product registration
- Abridged product registration
- Special access product registration
- Renewal of product registration
- Amendment and change notification
- Product license transfer
Our authorised representative services include:
- Liaison with the local authorised government agency on all regulatory issues relating to your medical device including amendment and change notifications
- Regulatory monitoring to alert you to any changes or new regulation applicable to your product
- License holding
- Adverse event reporting and management
- Product alert and recall tracking
- Complaint handling
We also offer additional support services such as:
- Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market
- Importation
- Storage and warehousing
- Relabelling
- Online regulatory training