The Nuclear Energy Regulatory Agency of the Republic of Indonesia (BAPETEN) has issued Regulation Number 1 of 2025 concerning the Conformity Assessment of X-ray Equipment for Diagnostic and Interventional Radiology. This regulation establishes the requirements and procedures to ensure X-ray equipment complies with applicable national and/or international safety standards.
The regulation applies to both locally manufactured and imported X-ray equipment and introduces specific certification pathways, assessment requirements, and transitional provisions.
Read the full regulation here: Regulation of BAPETEN No. 1 of 2025 (Provided in Indonesian only; English translation is not available).
Purpose of the Regulation
- To establish requirements for conformity assessment of X-ray equipment used in diagnostic and interventional radiology.
- To ensure compliance with applicable safety standards prior to use and distribution in Indonesia.
- To define certification schemes, assessment pathways, and roles of conformity assessment bodies.
- To regulate the issuance, validity, suspension, and revocation of conformity certificates.
Scope of Application
The regulation applies to the following types of X-ray equipment:
- General Radiography X-ray Equipment
- Fluoroscopy X-ray Equipment
- CT-Scan X-ray Equipment
Key Highlights
Conformity Assessment Framework
The regulation defines the scope and applicability of conformity assessment for X-ray equipment, including requirements for certification bodies and testing laboratories involved in the assessment process.
Eligible Applicants
Applications for conformity assessment may be submitted by:
- Manufacturers
- Brand owners
- Authorized representatives
- Distributors
- Government institutions
Certification Schemes and Assessment Pathways
Distinct conformity assessment pathways are established for:
- Locally manufactured products
- Imported products
These pathways outline specific documentation, testing, and certification requirements based on product origin.
Requirements for Imported Products
For imported X-ray equipment, conformity assessment must be conducted by a Conformity Assessment Body (LPK) located in the country of origin. The LPK must:
- Be accredited by an accreditation body that is a signatory to a multilateral recognition arrangement under ISO/IEC 17065.
- Obtain recommendation from BAPETEN.
- Be supported by an agreement on acceptance of conformity assessment results with a domestic Product Certification Body (LSPro).
The conformity assessment results are issued in the form of a certificate, which serves as the basis for applicants to obtain a conformity certificate from the domestic LSPro.
Transitional Provisions
- Certificates of conformity previously issued by the Head of the Agency remain valid until their respective expiry dates.
- All affected products must complete the full conformity assessment process within a maximum period of three (3) years in accordance with this regulation.
Implications to Clients
- At present, there is no direct regulatory impact on Andaman Medical Indonesia’s registered products, as we do not handle or register radiation-based devices, including X-ray equipment.
- This update is provided for regulatory awareness and informational purposes only.
- Should radiation-related products be registered in the future, compliance with this regulation will be mandatory and should be carefully evaluated.
Effective Date
4 August 2025
For inquiries or support regarding regulatory requirements for radiation-based medical devices in Indonesia, please contact sales@andamanmed.com.
