Atomic Energy (Radiation Protection) Rules, 2004
A CDSCO licence does not make a radiation-emitting device legal to sell
Manufacturers and importers of X-ray and other radiation-emitting medical equipment answer to two regulators, not one. CDSCO regulates the device. The Atomic Energy Regulatory Board regulates the radiation. Each has its own approvals, its own evidence and its own consequences for getting it wrong, and holding one does not help you with the other.
Medfins International maps which AERB consents apply to your equipment, prepares the type approval submission, and supports the facility and documentation requirements that sit behind a manufacturing licence.
What AERB requires
- Type Approval. Before commercial-scale manufacture, the prototype must be shown to meet the applicable safety code and standards. The competent authority issues a Type Approval Certificate only where the equipment satisfies those requirements.
- Licence for commercial production. Indigenous manufacturers require prior licensing from AERB to produce commercially.
- Procurement permission. Separate permission is needed for the procurement or import of X-ray tubes and tube inserts.
- eLORA. AERB’s e-Licensing of Radiation Applications system is the route through which consents are applied for and held.
What sits behind a manufacturing licence
AERB does not assess paperwork alone. A manufacturer applying for a licence is expected to have a dedicated radiation testing facility with appropriate shielding, radiation protection devices whose adequacy is verified periodically, quality assurance and dosimetry equipment with calibration traceable to national or international standards, trained personnel, and an approved Radiological Safety Officer. Testing data on equipment produced must be retained.
These are capital and staffing commitments. They are the reason a manufacturer who has budgeted only for a regulatory filing finds the AERB route longer than expected.
Type approval is tied to the design
A Type Approval Certificate is granted against a design. If the design specification changes, the approval becomes void, and it must be renewed before expiry. Manufacturers who treat a type approval as a permanent asset and then make a component substitution, a power supply change or a software-driven change to exposure control can find themselves selling equipment that is no longer covered.
Importers are not exempt
An importer bringing in equipment made abroad cannot rely on the overseas manufacturer’s home-market approvals. The equipment has to satisfy the Indian requirements, and the consents sit with the entity placing it on the Indian market. This is the single most common misunderstanding we are asked to unpick, usually after a consignment has already shipped.
Where this goes wrong
- Sequencing the two regulators wrongly. Firms complete the CDSCO route, then discover the AERB requirements months later, with stock already committed.
- Design changes after type approval. A change in design specification voids the approval. Engineering teams rarely know this.
- No Radiological Safety Officer in place. The RSO is not a formality that can be added at the end; the licence depends on it.
- Calibration that is not traceable. Dosimetry and QA equipment must have calibration traceable to national or international standards. In-house calibration without that chain does not satisfy the requirement.
- Assuming service and installation are outside scope. Service agencies for medical diagnostic X-ray equipment carry their own AERB expectations.
Frequently asked questions
Do we need AERB approval if we only import, not manufacture?
Importers placing radiation-emitting equipment on the Indian market are within AERB’s consenting framework. The specific consents depend on the equipment and your role in the supply chain.
Does a CE mark or FDA clearance satisfy AERB?
No. Overseas approvals may support the technical file, but they are not a substitute for Indian type approval or licensing.
How long is a Type Approval valid?
It must be renewed before expiry, and it becomes void if the design specification changes. Treat it as tied to a frozen design, not to the product name.
Can the same entity hold both the CDSCO licence and the AERB consent?
Usually yes, and it is generally preferable, because it keeps responsibility for the device and for its radiation safety in one place.
What about equipment that emits radiation incidentally?
Scope is decided by what the equipment does, not by how it is marketed. If there is any doubt, it should be resolved before import rather than at the port.