Kontak

Radiation Medical Device Registration

Distributing radiation-emitting medical devices in Indonesia requires compliance beyond the standard medical device pathway. Our radiation medical device registration service in Indonesia supports international manufacturers with the complete Kemenkes regulatory framework, from IDAK radiation amendment and CDAKB scope extension to product registration (AKL), ensuring your X-ray equipment, CT scan systems, mammography units, fluoroscopy machines, and radiotherapy devices are legally approved and market-ready.

Pesan Konsultasi

Dukungan Kepatuhan Tanpa Batas

Layanan Ujung ke Ujung

Kami mengelola seluruh jalur regulasi mulai dari perizinan hingga registrasi produk.

Keahlian Regulasi

Tim kami menggabungkan pengetahuan dan pengalaman mendalam untuk menavigasi lanskap regulasi yang kompleks.

Kecepatan dan Efisiensi

Strategi kami yang telah terbukti mempercepat proses pendaftaran dan persetujuan untuk pasar Indonesia.

Dukungan yang Disesuaikan

Memberikan panduan yang dipersonalisasi dan dukungan khusus untuk memastikan perjalanan yang lancar dan tanpa kekhawatiran.

Section: Why Choose Our Radiation Medical Device Registration Service in Indonesia?

Radiation electromedical devices fall under a distinct sub-classification in Indonesia’s medical device framework. Because these devices use electrical power to emit ionizing radiation for diagnostic or therapeutic purposes, they carry stricter technical, personnel, and documentation requirements than other device categories.

Distributing these devices legally requires three core components: a Medical Device Distribution License (IDAK) with an active Electromedical Radiation scope amendment, a CDAKB certificate covering radiation-specific quality management, and product registration (AKL) through the Ministry of Health’s Regalkes system. A critical requirement unique to this category is the appointment of a Radiation Protection Officer (PPR) holding active BAPETEN certification. Without a qualified PPR on file, the IDAK radiation electromedical amendment cannot proceed.

Product Registration Indonesia coordinates all three compliance requirements under one regulatory strategy. We help international manufacturers avoid the most common causes of delay: incomplete PPR credentials, gaps in the radiation-specific QMS, and IDAK applications with incorrect sub-category scope.

Area kepatuhan utama yang kami dukung meliputi:

  • IDAK amendment to include the Electromedical Radiation sub-category
  • CDAKB scope extension with radiation-specific QMS and SOPs
  • Product registration dossier preparation and MoH submission for radiation device classes
Pesan Konsultasi

Cakupan dan Manfaat Layanan Kami

Comprehensive regulatory support for radiation electromedical device distribution and registration in Indonesia.

IDAK Radiation Electromedical Amendment

We manage the amendment of the existing Medical Device Distribution License to include the Electromedical Radiation sub-category. This covers technical personnel verification (PPR and ATEM Technician credentials), facility documentation updates, and full MoH liaison until the updated IDAK radiation electromedical certificate is issued.

CDAKB Radiation Scope Extension
We prepare and update the Quality Management System to cover radiation-specific requirements, including safety SOPs, shielding maintenance protocols, and emergency response procedures, ensuring your CDAKB certification reflects the full Electromedical Radiation scope.
Medical Device Registration (AKL)
We manage classification review, dossier preparation, and Regalkes submission for radiation electromedical devices across all risk classes, from administrative and technical documentation through clarification handling and approval monitoring.
Pesan Konsultasi

Formulir Permintaan

Tim kami siap mendiskusikan kebutuhan bisnis Anda dan menjawab pertanyaan apa pun yang mungkin Anda miliki. Isi formulir pertanyaan kami, dan kami akan merespons dalam satu hari kerja.

Formulir Kontak
Kirimkan dengan email perusahaan Anda untuk respons yang lebih cepat dan penanganan prioritas.

Cara lain untuk menghubungi kami.

 Pertanyaan yang Sering Diajukan (FAQ)

This category covers devices that use electrical power and emit ionizing radiation or radioactive substances as part of their intended function. Examples include general X-ray units, dental and panoramic X-ray systems, CT scanners, mammography equipment, fluoroscopy systems, linear accelerators (LINAC), and PET/SPECT scanners. Each product requires a separate AKL registration through the Kemenkes Regalkes system.
X-ray equipment registration in Indonesia requires the distributing company to hold a valid IDAK with an active Electromedical Radiation scope, a CDAKB certificate covering radiation quality standards, and an approved AKL for each registered product model. X-ray equipment registration also requires the appointment of a BAPETEN-certified PPR as designated technical personnel within the local license holder company.
A standard IDAK authorizes a company to distribute non-radiation medical devices. To distribute radiation-emitting devices, the company must complete an amendment adding the Electromedical Radiation sub-category to its existing IDAK. This amendment involves stricter personnel credentials, facility documentation, and quality system requirements that do not apply to other device categories.
A PPR (Petugas Proteksi Radiasi) is a technically qualified officer with active BAPETEN certification. The Ministry of Health requires at least one PPR as designated technical personnel for all IDAK radiation electromedical applications. This is a mandatory requirement unique to this device category. If the client does not have a qualified PPR, Product Registration Indonesia can assist with the recruitment process.
CT scan import license requirements in Indonesia are managed through the Kemenkes IDAK radiation electromedical framework. To legally import and distribute CT scan systems, the local entity must hold a valid IDAK with Electromedical Radiation scope, a CDAKB certificate, and an AKL for each registered product model. Obtaining a CT scan import license through a neutral license holder like Product Registration Indonesia keeps your approvals transferable and independent from any single distributor.
Indonesian regulations require all product registrations to be held by a locally established entity. Foreign manufacturers can appoint an independent license holder, such as Product Registration Indonesia, to register and maintain their device approvals under a neutral, transferable structure, without tying market access to a single distributor.
Standard requirements include a Letter of Authorization (legalized by the Indonesian Embassy at country of origin), Certificate of Free Sale, ISO 13485 certificate, technical and clinical documentation, labeling in Bahasa Indonesia, and quality system records. Radiation-specific registration additionally requires PPR and ATEM Technician credentials and updated facility documentation. The exact scope depends on the device risk class.
Our service covers the Kemenkes regulatory pathway: IDAK radiation amendment, CDAKB radiation scope extension, and AKL product registration. BAPETEN-specific permits, including import licenses via the BALIS Online system and transfer permits for individual device units, fall outside our standard service scope. We can provide guidance on the BAPETEN pathway and refer clients to appropriate specialists when needed.
The amendment process generally takes 50 to 90 working days from the point when all required documents, including PPR credentials and updated facility documentation, are in place. Timelines may vary depending on MoH review queues and whether a physical facility inspection is required.
Registration approval is valid for five years and requires renewal before expiry. Post-registration obligations include maintaining CDAKB compliance, reporting product or labeling changes to the MoH, and periodic surveillance by the Ministry of Health. Product Registration Indonesia provides ongoing compliance and renewal support to help manufacturers sustain their radiation medical device registration in Indonesia throughout the full product lifecycle.

Kepemimpinan Strategis dengan
Dr. Hussein H. Mashhour, MD

Sebagai Chief Operating Officer (COO) kami, Dr. Hussein H. Mashhour, MD, membawa lebih dari satu dekade pengalaman langsung yang berdedikasi dalam pendaftaran dan perizinan produk di berbagai sektor regulasi paling kompleks di Indonesia. Pengawasan strategisnya memastikan bahwa prosedur operasional dan layanan klien kami dibangun di atas proses yang terbukti efisien. Mulailah perjalanan Anda dengan keyakinan dan kejelasan yang hanya dapat diberikan oleh seorang pemimpin ahli di bidang kepatuhan dan operasional.

Pesan konsultasi gratis
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