Jasa Pengurusan IDAK Resmi, Konsultan Izin Distribusi Alat Kesehatan
Simplify Your Medical Device Distribution Legality with PT Multi Jasa Berjaya
What Are IPAK and IDAK According to the Latest Ministry of Health Regulations?
Izin Distribusi Alat Kesehatan (IDAK) adalah izin yang diberikan kepada perusahaan yang melakukan kegiatan penyimpanan, penyaluran, dan distribusi alat kesehatan di Indonesia. IDAK merupakan bukti bahwa perusahaan telah memenuhi persyaratan dan standar yang ditetapkan untuk menjamin mutu, keamanan, dan manfaat alat kesehatan yang didistribusikan.
Ketentuan mengenai IDAK diatur dalam Peraturan Menteri Kesehatan Republik Indonesia Nomor 14 Tahun 2021 tentang Standar Kegiatan Usaha dan Produk pada Penyelenggaraan Perizinan Berusaha Berbasis Risiko Sektor Kesehatan. Dengan memiliki IDAK, perusahaan dapat menjalankan kegiatan distribusi alat kesehatan secara legal serta menerapkan Cara Distribusi Alat Kesehatan yang Baik (CDAKB) sesuai ketentuan yang berlaku.Jika yang Anda maksud adalah dasar hukum terbaru IDAK pada tahun 2025 atau 2026, saya dapat membantu menyesuaikannya dengan regulasi yang berlaku saat ini.
Tujuan utama kepemilikan Izin Distribusi Alat Kesehatan (IDAK) adalah untuk memberikan legalitas kepada perusahaan agar dapat melakukan kegiatan penyimpanan, penyaluran, dan distribusi alat kesehatan secara sah sesuai dengan ketentuan yang berlaku di Indonesia
Who Must Have an IPAK/IDAK License?
Local Business Operators
Domestic companies that sell medical devices—either directly or through distributors—are required to obtain an IPAK/IDAK license as the legal basis for their distribution activities.
Medical Device Importers and Distributors
Companies that import medical devices from abroad for distribution in Indonesia are also required to obtain an IDAK license to ensure that their distribution activities are legally authorized.
Main Requirements for Obtaining an IDAK License
To obtain an IDAK license, companies must fulfill both administrative and technical requirements as follows:
- KBLI 46791
Telah tercantum sebagai kegiatan utama di NIB (yang sudah berbasis OSS RBA) dan Akta Perusahaan sesuai KBLI 2025. - Technical Personnel
At least one qualified technical expert according to the classification of medical devices. For electromedical radiation devices,a Radiation Protection Officer (PPR) is required. - Facilities and Infrastructure Document
The physical building must be available and ready for layout adjustment as advised by MJB consultants. - Fixed Telephone Number & Permanent Address
The office and warehouse addresses must not be virtual offices and must have a fixed telephone line (with area code 021). - One Address – One IDAK
Each address is allowed to have only one active IDAK license.
Note: Additional documents such as statements, organizational structure, and medical device lists will be prepared by the MJB team for signing by the Director and Responsible Technical Officer (PJT).
How We Help – IDAK Licensing Process at MJB
- Initial Consultation
Needs assessment, medical device classification, and preliminary document review. - Document Collection
The MJB team assists in completing all administrative and technical documents in accordance with Ministry of Health regulations. - Facility and Infrastructure Arrangement
Our team provides on-site guidance for warehouse and office layout adjustments (onsite for Jabodetabek, online meetings for other regions). - Submission to the Ministry of Health
All verified documents are submitted through the official online system. - Monitoring and License Delivery
MJB monitors the process until the official license is issued and delivered to your company.
Why Choose Us?
Experienced & Trusted
MJB has assisted dozens of medical device and household health product (PKRT) companies in obtaining official Ministry of Health licenses quickly and legally.Fast & Transparent Process
Clear time estimates and regular progress reports at every stage of the licensing process.Compliant with Ministry of Health Regulations
All procedures strictly follow Permenkes No. 14 of 2021, ensuring every application is official, legal, and risk-free.
Frequently Asked Questions (FAQ)
How long does the IDAK licensing process take?
The average processing time is 2–4 weeks, depending on document completeness and the Ministry of Health’s system queue.Does MJB assist in document preparation?
Yes, we assist from start to finish, including preparing statements, forms, and technical documents.Is the service available across Indonesia?
Yes, we serve clients throughout Indonesia, regardless of location.
Artikel Terkait
- Preparation Steps Before Applying for an IDAK License: A Practical Guide for Medical Device Distributors
- Planning to Distribute Medical Devices? Effective Ways to Obtain a Medical Device Distribution License
- Must Know! Notarial Deed of Cooperation with the Responsible Technical Officer (PJT): A New Requirement for Medical Device Distribution
- Sertifikasi CDAKB: Kenali Persiapan yang Harus Anda Lakukan
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