Indonesia Household Health Product (PKRT/PKL) Registration Licence

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

The Directorate General of Pharmaceuticals and Medical Devices (Ditjen Farmalkes) is a first-level unit of the Ministry of Health, tasked with organising the formulation and implementation of policy in the field of pharmaceutical management and medical devices. This task is further elaborated through the following functions: formulating policy in the fields of pharmaceutical and medical-device resilience, pharmaceutical preparations, the production and distribution of medical devices and household health products, the regulation of medical devices and household health products, the governance of health products, and pharmaceutical services; implementing such policy; drafting norms, standards, procedures and criteria in these fields; providing technical guidance and supervision in these fields; carrying out monitoring, analysis, evaluation and reporting in these fields; implementing the Directorate General's administrative management; and performing other functions assigned by the Minister.

Values

As part of the Ministry of Health, the Directorate General takes the Ministry's values as the foundation for the institution, its leadership and all staff in their service, work and conduct. These values include: People-first — in organising health development, the Ministry of Health always puts the interests of the people first and must create the best outcomes for them. Attaining the highest standard of health is the right of every person, regardless of race, class, religion or socio-economic status. Inclusiveness — all health-development programmes must involve all parties, because health development cannot be accomplished by the Ministry of Health alone; all sectors of society must actively participate, including cross-sector agencies, professional organisations, community organisations, businesses, civil society and grassroots communities. Responsiveness — health programmes must meet the needs and expectations of the people and remain responsive to regional issues, local conditions, socio-cultural and geographic conditions, which are the basis for addressing different health problems and therefore require different approaches. Effectiveness — health programmes must achieve significant results in line with set objectives and be efficient. Integrity — health-development implementation must be free of corruption, collusion and nepotism (KKN) and maintain transparency and accountability.

Household health product (PKRT) registration licence

To ensure the quality, safety and efficacy of domestic and imported medical devices circulating in Indonesia, medical devices and household health products must be controlled. All medical devices (ALAT KESEHATAN) and household health products (PKRT) must obtain a licence before being distributed and used. The Household Health Product Distribution Licence (IZIN EDAR PERBEKALAN KESEHATAN RUMAH TANGGA) is an official distribution licence issued by the Indonesian Ministry of Health (Kementerian Kesehatan Indonesia), ensuring that products meet national standards for safety, quality and effectiveness. Any household health product must obtain this licence before entering the market. Companies must submit administrative licensing documents, product technical documents, test reports and a declaration of conformity, and can only be issued a certificate after passing the assessment. The public can check the licence status through the Ministry of Health's (Kemenkes) Info Alkes website. Once the licence is obtained, the product can be legally sold and used, helping to protect patient safety and regulate industry order.

Household health product marketing-authorisation numbers

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

Household health product marketing-authorisation process

1. Fill in the application form; 2. Document review and gap assessment; 3. Submit registration; 4. Review; 5. Issue the certificate; 6. Renewal/change application.