Chapter 1 Indonesian MOH administration information abstract

1. Administration and Abstract

The major government agency responsible for medical device regulation in Indonesia is the Ministry of Health Republic of Indonesia (MOH). The agency is responsible for pre-market and post-market evaluation, standardization, legislation, and Good Manufacturing Practice (GMP) certification of medical devices.

In accordance with No. 5, Section 5 of Ministry of Health Order 2022, the MOH performs the following functions:

①Formulate, define and implement policy coordination tasks in the areas of public health, disease prevention and control, health services, medicines, medical devices and health personnel, providing guidance and administrative support to all organizations within the Ministry of Health Republic of Indonesia;

② Manage State property under the responsibility of the Ministry of Health;

③Supervise the implementation of the duties of the Ministry of Health;

④Provide technical guidance and supervision on the implementation of the Ministry of Health affairs in all regions;

⑤Formulate and provide health development policy recommendations；

⑥Provide substantive support to all parts of the Ministry of Health.

Any medical devices, in-vitro diagnostic medical devices and PKRT (Perbekalan Kesehatan Rumah Tangga, family health products, PKRT) products entering the territory of the Republic of Indonesia for sale in the Indonesian market need to be registered and obtain the corresponding registration certificate.

2. Administrative Regulation

Regulation of the Minister of Health No. 62 of 2017 concerning Medical Devices and Household Health Supplies ：

The regulation stipulates the requirements for registration, classification, production, sales and supervision of medical devices, covering the definition, classification standards, registration procedures and market access requirements of medical devices. Indonesia regulation references to relevant ASEAN regulations (such as the ASEAN Medical Device Directive), specific registration and supervision guidelines, etc.

3. Risk Level Classification of Medical Device and IVD Products

According to the possible risk to patients caused by the use of medical devices, divide products from low to high:

Based on the risk of misinterpretation of test results for individuals and the public, in vitro diagnostic medical devices are divided into:

4. Entry requirements

When foreign manufacturers sell medical devices in Indonesia, they must appoint a single local agent. This agent will assume local responsibility for product registration, sales and after-sales service.

Establish a quality management system in accordance with ISO 13485 to ensure product quality. 

Prepare detailed technical documentation based on the ASEAN Common Submission Dossier Template (CSDT) and in compliance with Indonesian regulations and standards, including product design, specifications, manufacturing process, material composition, performance characteristics, clinical trial data (if applicable), etc.

For certain high-risk or specific medical devices, clinical trial data may be required to demonstrate the safety and efficacy of the product. Clinical trials need to be conducted by approved institutions and meet ethical and regulatory requirements.

5. Registration Language

English and Indonesian.

6. Indonesian Sole Agent / Sole Distributor / Exclusive Distributor

Sole Agent/Sole Distributor/Exclusive Distributor means an importer of PAK or PKRT designated by the manufacturer or consignor to register and distribute medical devices, in vitro diagnostic devices and PKRT in the Republic of Indonesia as a representative and to provide after-sales services for medical devices, in vitro diagnostic devices and PKRT.

If the application for a product license is submitted by a PAK or PKRT company that is designated as a Sole Agent/Sole Distributor/Exclusive Distributor and/or authorized to register, the validity of the product license is the same as the validity of such designation or authorization.

A product certificate is declared invalid if:

① Expired product certificate;

② Production certificate expired;

③ PAK certificate expired;

④ General agent/general distributor/exclusive distributor and/or authorization expired or not extended; or

⑤ Product certificate is revoked.

Chapter 2 Registration Flow

1. Registration Flow

Pre-registration is the process by which assessors validate the classified risks of medical devices to determine non-tax revenue costs.

① Applicants should go through the website http://www.regalkes.depkes.go.id as required to. The result of the pre-registration assessment will be notified through the website and email. The applicant should actively check and verify the assessment result.

② The assessor shall classify the medical device as risky within a maximum of 7 days.

③ The applicant will receive an email notification of the non-tax revenue fee, which must be paid based on the classification of the medical device.

④ The applicant must pay the non-tax fee and upload the payment receipt within 14 days of receiving the non-tax fee notification.

⑤ Evaluation and validation for data completion has not yet begun at the pre-registration stage.

Registration documents that do not meet the requirements will be given two opportunities to submit supplementary data, and each supplementary data should be completed within 30 days of submission.

2. Cycle & Official Fee

The requirements and duration of time required to obtain marketing authorization depend on the risk classification of the medical device.

Chapter 3 FAQ

Q: Where is licensed EDAR HeALTH TOOLS available

A: For the implementation of transparent and accountable public services, an application for registration of medical device distribution license can be achieved through the web site, http://, www.regalkes.depkes.go.id and/or the ministry of health of Indonesia integrated service for online application.

Q: Does it require a QMS certificate for Indonesian registration of medical devices?

A: If a medical device is registered in Indonesia, the manufacturer must establish and maintain an appropriate quality management system, such as compliance with ISO 13485 standards, to ensure that the manufacturing and quality control processes of the product comply with international standards.

Q: What are the types of services authorized for medical device marketing in Indonesia?

A: New medical device product application, medical device renewal application, medical device change application, medical device renewal application.

Q: How long is the validity period of medical device marketing authorization in Indonesia?

A: The validity period of the marketing authorization renewal will be consistent with the Letter of Attorney (LoA), which is valid for a minimum of 2 years and a maximum of 5 years.

Q: Can we change Indonesian authorized representative?

A: Sure. The change of corporate information in Indonesia includes the change of company address, contact information, authorized representative, etc., which belongs to the scope of change management after the BPOM registration of medical devices in Indonesia.

When making changes to authorized representatives, it is usually necessary to prepare relevant materials and go through certain procedures. Specifically, it may be necessary to provide a change description, relevant qualification documents of the newly authorized representative, etc., and submit a change request through BPOM's online system such as e-bpom.

Q: Can a product be registered by multiple authorized representatives at the same time?

A: No. At Permenkes 2017 Article 62 Article 13, Each type of medical device, in vitro diagnostic medical device and imported PKRT, bearing one (1) trade mark/brand name originating from the manufacturer or principal, may only be represented by one (1) PAK or one (1) PKRT importer. One brand, one type cannot be represented by different distributors.

Q: Can Indonesian medical devices be changed and renewal?

A: Sure. Change is acceptable during the validity period of the license, changes should be through http://www.regalkes.depkes.go.id online system selection menu.