Organization Introduction

Indonesia's Directorate General of Pharmaceuticals and Medical Devices (Ditjen Farmalkes)

The General Directorate for Pharmaceuticals and Medical Devices (Ditjen Farmalkes) is a first-level agency within the Ministry of Health, tasked with organizing the formulation and implementation of policies in the areas of pharmaceutical administration and medical devices. This task is further elaborated through the following functions:

- Formulate policies in areas such as pharmaceutical and medical device resilience, pharmaceutical formulations, production and distribution of medical devices and household hygiene products, regulation of medical devices and household hygiene products, governance of hygiene products, and pharmaceutical services;

- Implement policies in the areas of pharmaceutical and medical device resilience, pharmaceutical formulation, production and distribution of medical devices and household hygiene products, supervision of medical devices and household hygiene products, governance of hygiene products, and pharmaceutical services;

- Draft regulations, standards, procedures and norms in the fields of pharmaceutical and medical device resilience, pharmaceutical preparations, production and distribution of medical devices and household hygiene products, supervision of medical devices and household hygiene products, governance of hygiene products and pharmaceutical services.

- Provide technical guidance and supervision in the fields of pharmaceutical and medical device resilience, pharmaceutical formulation, production and distribution of medical devices and household hygiene products, regulation of medical devices and household hygiene products, governance of hygiene products, and pharmaceutical services;

- Conduct monitoring, analysis, evaluation and reporting work in the fields of pharmaceutical and medical device resilience, pharmaceutical formulation, production and distribution of medical devices and household hygiene products, supervision of medical devices and household hygiene products, governance of hygiene products and pharmaceutical services;

- To implement the General Administration's administrative management work; and

- Perform other functions assigned by the Minister.

Values

As part of the Ministry of Health, the State Drug Administration takes the Ministry of Health's values ​​as the foundation and basis for the service, work, and conduct of its organization, leadership, and all staff. These values ​​include:

People-oriented

In organizing health development, the Ministry of Health always puts the interests of the people first and must strive to create the best outcomes for them. Achieving the highest level of health is the right of everyone, regardless of race, class, religion, or socioeconomic status.

tolerate

All health development projects must involve all stakeholders, as health development cannot be accomplished by the Ministry of Health alone. Active participation from all sectors of society is essential, including inter-agency agencies, professional organizations, community organizations, businesses, civil society, and grassroots communities.

responsiveness

Health programs must meet the needs and expectations of the people and be responsive to regional issues, local conditions, socio-cultural factors, and geographical context. These factors form the basis for addressing different health problems, thus requiring different approaches.

Validity

Health programs must achieve significant results and be highly efficient in accordance with established objectives.

Integrity

Health development must be implemented in a way that eliminates corruption, cronyism and favoritism (KKN) and maintains transparency and accountability.

medical devicesregisterlicense

To ensure the quality, safety, and effectiveness of domestically produced and imported medical devices circulating in Indonesia, it is essential to regulate medical devices. All medical devices (MEDICAL DEVICESProducts and household hygiene products (PKRT) must be licensed before they can be distributed and used.

A Medical Device Distribution License (IZIN EDAR ALAT KESEHATAN) is an official distribution permit issued by the Indonesian Ministry of Health (Kementerian Kesehatan Indonesia) to ensure that products meet national standards in terms of safety, quality, and effectiveness. This license is mandatory for any medical device before it can enter the market. Companies must submit product technical documentation, test reports, and a declaration of conformity, and pass an evaluation before receiving a certificate. The public can check the license status through the Ministry of Health's (Kemenkes) Info Alkes website. Once licensed, products can be legally sold and used, helping to protect patient safety and regulate the industry.

What is a medical device market license?

A market access license is a permit granted to a company to import, use, or distribute medical device or home health product (PKRT) products within the Republic of Indonesia. This license is issued based on an assessment of its quality, safety, and effectiveness.

According to the "Guidelines for Medical Device Marketing Authorization Services" issued by the Ministry of Health of the Republic of Indonesia in 2016, marketing authorizations for medical devices and home health products are issued by the Minister of Health. More specifically, marketing authorizations for medical devices and home health products are issued by the Director General of the Pharmaceuticals and Medical Devices Agency. The issuance of marketing authorizations involves a rigorous evaluation process. During this evaluation, medical devices and home health products must declare compliance with three main requirements: safety, quality, and effectiveness.

Medical Device Marketing Authorization NumberDomestic medical devices: KEMENKES RI AKD XXXXXXXXXXXX Imported medical devices: KEMENKES RI AKL XXXXXXXXXXXX

Medical Device Market Authorization Process

1. Fill out the application form;

2. Written review and gap assessment;

3. Submit registration;

4. Review;

5. Issuance of certificates;

6. Renewal/Change Application.