Indonesia

Medical Device Registration

Medical Device Registration in Indonesia

Government Authority

The primary government agency responsible for regulation of medical devices in Indonesia is the Ministry of Health (MoH). The authority is also in charge of pre-market and post market evaluation, standardization, legislation and Good Manufacturing Practices (GMP) certification. Prior to importation, Medical Devices and IVDs must receive a registration number and product license (AKA marketing license) issued by the Ministry of Health to a local, licensed distributor.

Regulatory Efficiency

Medical Device registration in Indonesia is a relatively fast and inexpensive process particularly considering the size of the country. Prior to importation, medical and IVD devices must receive a registration number and product license (AKA marketing license) issued by the MoH to a local, licensed importer (license holder).

Medical Device Status

Instruments, devices and apparatus that diagnose, prevent, monitor, treat or reduce illness are considered Medical Devices in Indonesia. Devices that contain pharmaceuticals are not considered medical devices.

Product Categorization

Medical device classification in Indonesia closely follows GHTF Classification guidelines and are being harmonized according to the ASEAN Medical Devices Directive with four classes A, B, C and D, ranked from low to high risk categorization. The registration routes vary based on the classification of the device:

Class A Medical Device or IVD Device	15 days	US$115 (Indonesia Rupiah 1,500,000)
Class B Medical Device or IVD Device	30 days	US$230 (Indonesian Rupiah 3,000,000)
Class C Medical Device or IVD Device	30 days	US$230 (Indonesian Rupiah 3,000,000)
Class D Medical Device or IVD Device	45 days	US$340 (Indonesian Rupiah 5,000,000)

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Documents Required for Indonesia Medical Device Registration

Registration applications must be submitted in accordance with the local form, most of the contents of the form are similar to ASEAN Common Submission Dossier Template (CSDT).

The ASEAN Common Submission Dossier Template (CSDT) includes:

Executive Summary
Device Labelling/IFU
Detailed Manufacturer Information
Summary of Design verification and validation documents
Risk Analysis
Quality Management Certification (ISO 13485)
Clinical Evaluation Report
Free Sales Certificate
Risk Management Report
Flow Manufacturing process
Raw Materials Used
Design verification and validation or Sterilization validation
Biocompatibility
Declaration of Conformity
Letter of Confirmation for market history proof from manufacturer
Letter of Authorization
Good Distribution Practice for Medical Devices (GDPMD)

Reference Countries

Australia – Canada – European Union – Japan – United States

Efficiency Review

Medical device registration in Indonesia includes administrative documents such as a device labeling, device description, including, features, intended use, indications, instructions for use, contraindications, warnings, precautions, potential adverse effects, and other relevant specifications. Some devices may require documentation of pre-clinical studies and risk analysis assessments.

Note that Marketing Licenses are limited to 500 parts, before being split into two applications / AKL licenses. Electromedical equipment is limited to 200 product codes.

Quality Systems Conformity Assessment

Indonesia medical device registration requires ISO 13485 certificates to certify the quality system/s of the legal and/or actual manufacturing facilities.

Validity and Renewal

Product licenses are valid for two to five years in Indonesia, depending on the validity period of the Letter of Authorization. Indonesian regulation (Decree of Ministry of Health No. 62 /2017; article no. 30) provides for amending an existing product license to account for changes to the packaging design, labeling content, accessory’s part number, product number, change of legal manufacturer address, change of license holder address. All other product changes would require a new registration submission.

The renewal fee is US$75 (Indonesia Rupiah 1,000,000).

The license renewal can be included with the amendment license (in a single application) with government fees of IDR 1,500, 000. Renewal or amended is only IDR 1,000,000. Amendment and renewal process will be 10-15 working days.

Licenses are non-transferable, and only one can be valid per device at one time.Under new regulations, manufacturers can unilaterally terminate their license (in situations with uncooperative distributors) but will need to wait 6 months before reapplying.

License Holder Requirements

Medical Device registration requires a Sole Importer. A Local agent must submit the application and hold the license. An agent is granted power of attorney to hold the registration license on behalf of a foreign manufacturer. Additionally, the License Holder must be involved in the importation process.

License Transfer

To transfer a valid product license from one local agent to another requires that the original license be cancelled, and a new application filed. The process can complicated and does require the full cooperation of the original license holder. If the license holder is not cooperative and refuses to give up the Letter of Authorization, the MOH mandates a 6-month waiting period before manufacturers can reapply. During this time, the MOH will reach out to the distributor and if the license cancellation is contested by the distributor, the MOH may decide to grant an additional 6 month extension where they ask the manufacturer and distributor to settle the dispute internally.

Benefits of Independent License Holder

Sell directly to multiple regional distributors, avoiding mark-up by a national importer
Increase transfer pricing
Improve leverage in distributor negotiations/responses
Add or change distributors as required
Keep intellectual property away from local commercial agents
The e-Catalogue system also increases the importance of independent license holding in Indonesia because there is no room for regional-dealer margin under the price scheme.

Contact Asia Actual for assistance with medical device regulations in Indonesia

Ilham Hidayattulah Principal Consultant, Asia Actual Indonesia

Ilham’s Regulatory Hint

“Products that enter, distribute and sell within the territory of Indonesia must be halal certified.”

Contact Us

US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: Indonesia@asiaactual.com

Frequently Asked Questions

Do I need to register my medical device in Indonesia?

Instruments, devices and apparatus that diagnose, prevent, monitor, treat or reduce illness are considered Medical Devices in Indonesia and require registration. Devices that contain pharmaceuticals are not considered medical devices.

Who can submit submit applications in Indonesia?

A local entity must submit applications, hold the license, and correspond with the Ministry of Health. License Holders will then need to be a part of the importing process.

How are products classified in Indonesia?

Medical devices are classified into 4 categories according to GHTF guidelines; from low-risk Class A to high-risk Class D.

How long does it take to register my medical device in Indonesia?

Registrations in Indonesia are reviewed in about 1 to 2 months.

Class A: 15 days
Class B and C: 30 days
Class D: 45 days

How much does it cost to register my device in Indonesia?

Registration fees in Indonesia will range from ~US$115 for Class A to ~US$340 for Class D.

For the complete list, please see our Registration page on the topic here.

How long are medical device licenses valid in Indonesia?

Medical device licenses are valid for 5 years and will then need to be renewed through a fairly simple administrative process.

Does the license holder need to be a part of the importing process?

Yea, license holders must be part of the importing process.

Is there an expedited review pathway?

No, there is not an expedite review process in Indonesia. Products are approved in 15 to 60 days which is much quicker than many markets in the region.

Is ISO 13485 required for medical devices in Indonesia?

Yes, ISO 13485 is required for registration in Indonesia.

Is Home Country approval required?

No, there are no requirements for home country approval but reference country approval is required for foreign manufacturers.

Do documents need to be translated to Indonesian (Bahasa) as part of the application process?

Yes, some application documents will need to be translated including the Instructions for Use (IFU) and the labeling, especially for home-use products.

For more information on labeling requirements, please see our page on the topic here.