Indonesia Medical Device (IDAK/AKL) Marketing Authorisation

Medical device registration in Indonesia is administered by the Directorate General of Pharmaceuticals and Medical Devices (Ditjen Farmalkes), a first-level unit of the Ministry of Health, which is responsible for setting and implementing policy in the fields of drug control and medical devices. To ensure the quality, safety and effectiveness of both domestic and imported medical devices circulating in Indonesia, all medical devices (ALAT KESEHATAN) and household health products (PKRT) must obtain a licence before distribution and use. A Medical Device Distribution Licence (Izin Distribusi Alat Kesehatan) is an official distribution licence issued by the Indonesian Ministry of Health (Kementerian Kesehatan), confirming that a product meets national standards for safety, quality and effectiveness. Any medical device must obtain this licence before entering the market. Companies must submit the product's technical documents, test reports and declaration of conformity, and can only be issued the certificate after passing the assessment. The public can check licence status through the Ministry of Health's Info Alkes website. Once the licence is obtained, the product can be legally sold and used, helping to protect patient safety and regulate the industry. What Is a Medical Device Marketing Authorisation? A marketing authorisation is the licence granted to a company to import, use or distribute a medical device or household health product (PKRT) within the Republic of Indonesia. The licence is issued on the basis of an assessment of quality, safety and effectiveness. According to the Ministry of Health's 'Medical Device Marketing Authorisation Service Guide', issued in 2016, marketing authorisations for medical devices and household health products are issued by the Minister of Health, and more specifically by the Director General of Pharmaceuticals and Medical Devices. The marketing authorisation is granted through a rigorous assessment process, during which the medical device or household health product must be declared to meet three main requirements: safety, quality and effectiveness. Medical Device Marketing Authorisation Number Domestic medical device: KEMENKES RI AKD XXXXXXXXXXXX Imported medical device: KEMENKES RI AKL XXXXXXXXXXXX Medical Device Marketing Authorisation Process Complete the application form; Document review and gap assessment; Submit the registration; Review; Issuance of the certificate; Renewal / variation application.