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.

PKRT Registration License for Household Hygiene Products

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

The Household Hygiene Products Distribution Permit (IZIN EDAR PERBEKALAN KESEHATAN RUMAH TANGGA) is an official distribution permit for medical devices issued by the Indonesian Ministry of Health (Kementerian Kesehatan Indonesia), ensuring that products meet national standards in terms of safety, quality, and effectiveness. Any household hygiene product must obtain this permit before entering the market. Companies must submit administrative permit documents, product technical documents, test reports, and a declaration of conformity, and pass an evaluation before receiving a certificate. The public can check the permit status through the Ministry of Health's (Kemenkes) Info Alkes website. Once the permit is obtained, the product can be legally sold and used, helping to protect patient safety and regulate industry order.

Household hygiene product market license number

Domestic medical devices: KEMENKES RI PKD XXXXXXXXXXXX Imported household hygiene products: KEMENKES RI PKL XXXXXXXXXXXX

Market Licensing Process for Household Hygiene Products

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.