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Hong KongRegulatory compliance guide

# Hong Kong Radiation Ordinance: Import and Licensing for Electronics with Radiation Sources

Hong Kong's Radiation Ordinance (Cap 303) requires RPS licences for the import, possession, and use of controlled irradiating apparatus — including XRF analysers, industrial X-ray inspection equipment, and analytical CT systems widely used in electronics manufacturing and quality control. Electronics companies importing this equipment into Hong Kong, or supplying it to Hong Kong customers, must ensure RPS licensing is in place before arrival, backed by complete technical documentation from the manufacturer.

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At a glance

Law

Radiation Ordinance (Cap 303)

Authority

RPS, Department of Health

Controlled equipment

X-ray, XRF, industrial CT

RF devices

OFCA (separate framework)

## Radiation Ordinance compliance for electronics

### Hong Kong Radiation Ordinance (Cap 303)

Hong Kong's Radiation Ordinance (Cap 303) regulates the import, possession, use, manufacture, sale, and disposal of radioactive materials and irradiating apparatus. Administered by the Radiation Protection Section (RPS) of the Department of Health, the Ordinance covers both naturally occurring and artificial radiation sources. For electronics hardware companies, the primary relevance is to irradiating apparatus — devices that emit ionising radiation including X-ray generators, industrial CT scanners, and electronic testing equipment with X-ray sources.

### Controlled irradiating apparatus and licensing

Irradiating apparatus listed as controlled under the Radiation Ordinance (including X-ray generators, electron accelerators, and certain analytical instruments) require a licence from the Director of Health (administered by RPS) for import, possession, and use in Hong Kong. This applies to: X-ray fluorescence (XRF) analysers used in electronics manufacturing quality control, industrial X-ray inspection equipment used for PCB or solder joint inspection, and computed tomography (CT) systems used for failure analysis or quality inspection of electronic assemblies.

### Non-ionising radiation and consumer electronics

Consumer electronics that emit non-ionising electromagnetic radiation (radio waves, microwave, infrared, visible light, UV, and laser) are not generally subject to the Radiation Ordinance. Radio frequency emission from WiFi, Bluetooth, and cellular devices is regulated by the TDRA equivalent in HK (OFCA — Office of the Communications Authority) under the Telecommunications Ordinance (Cap 106), not the Radiation Ordinance. Laser-emitting electronics (laser pointers, LiDAR sensors, laser barcode scanners) may be regulated by separate laser safety standards and require consideration of IEC 60825-1 laser safety classification.

### Import registration and manufacturer obligations

Electronics companies importing controlled irradiating apparatus into Hong Kong must obtain a RPS import licence before shipment. The application process requires: description of the apparatus and its intended use, manufacturer specifications and technical data, radiation shielding information, and identification of the licence holder responsible for safe use. Manufacturers supplying controlled irradiating apparatus must provide complete technical documentation to enable their Hong Kong customers to complete RPS licensing — failure to provide adequate technical data is a common cause of import delays.

## Licensing and documentation steps

01

Determine whether your electronics product is a controlled irradiating apparatus under Cap 303: if your product contains or generates ionising radiation (X-rays, gamma rays, electron beams) — including XRF analysers, X-ray inspection systems, or analytical CT — it is controlled and requires RPS licensing for import and use in Hong Kong.

02

For controlled irradiating apparatus, prepare the technical documentation required for RPS licence applications: radiation output specifications, beam characteristics, shielding design, operating manual, and safety interlocks — your Hong Kong customer will need this to apply for their import and use licence.

03

For non-ionising radiation (WiFi, Bluetooth, cellular, infrared, laser), check the applicable Hong Kong regulatory framework: OFCA (for radio frequency emissions), laser safety standards (IEC 60825-1 for laser products), and ensure your product's RF type approval from OFCA is in place for radio-enabled devices.

04

For laser-containing electronics (LiDAR sensors, laser barcode scanners, optical communications equipment), classify the laser according to IEC 60825-1 safety classes — Class 3B and Class 4 lasers require additional safety measures and documentation; supply the classification in your product technical file and user manual.

05

Register your company with RPS if you regularly import or supply controlled irradiating apparatus in Hong Kong — establishing a registered relationship with RPS simplifies repeated import licence applications for your product lines.

06

Review your electronics manufacturing inspection equipment: if you use X-ray equipment for PCB inspection, XRF for RoHS material analysis, or industrial CT for quality inspection at a Hong Kong facility, verify that each piece of controlled apparatus has a current RPS licence and that licence renewals are tracked.

07

For demonstration or exhibition of controlled irradiating apparatus at Hong Kong trade shows or customer sites, check whether a temporary licence is required — RPS issues temporary licences for specific events, but advance application is required.

## Frequently asked questions

### Do all X-ray-generating devices require RPS licences in Hong Kong?

X-ray generating devices listed as controlled irradiating apparatus under Cap 303 require RPS licences for import, possession, and use. This covers medical X-ray equipment, industrial X-ray inspection systems, XRF analysers, and similar devices. The definition of controlled apparatus includes most industrial X-ray equipment used in electronics manufacturing quality control. However, low-output, fully enclosed X-ray apparatus designed for specific purposes (such as some dental units or security scanners) may have different licensing pathways — check with RPS for your specific equipment type.

### Is there an OFCA type approval process for radio-enabled electronics in Hong Kong?

Yes — the Office of the Communications Authority (OFCA) regulates telecommunications apparatus in Hong Kong under the Telecommunications Ordinance (Cap 106) and the Radio Communications Ordinance (Cap 106A). Radio-enabled electronics (WiFi, Bluetooth, cellular, 5G, RFID, LoRa, etc.) require OFCA type approval before being sold or used in Hong Kong. OFCA accepts type approval test reports from recognised testing organisations, and maintains an online registry of approved telecommunications apparatus. The OFCA type approval process is separate from the Radiation Ordinance framework.

### How are laser safety standards applied to electronics in Hong Kong?

Laser safety in Hong Kong is primarily governed by IEC 60825-1 (Safety of laser products), adopted as a voluntary standard but referenced in product liability and import safety frameworks. Electronics containing lasers — LiDAR sensors, optical distance measurement modules, barcode scanners, optical communications equipment — must be classified according to IEC 60825-1 laser safety classes (Class 1 to Class 4, with higher classes requiring more safety measures). Class 3B and 4 lasers require mandatory warning labels, safety interlocks, and in some cases RPS notification. Most consumer laser electronics (Class 1 or 1M) do not require licensing.

### What happens if controlled irradiating apparatus is imported into Hong Kong without an RPS licence?

Importing controlled irradiating apparatus without the required RPS licence is an offence under the Radiation Ordinance (Cap 303). Unlicensed apparatus can be detained by Hong Kong Customs and subjected to enforcement action. The Director of Health can order the forfeiture and disposal of unlicensed radioactive materials or irradiating apparatus. Penalties for Radiation Ordinance offences include fines and imprisonment for serious or repeat violations. RPS is the point of contact for pre-import enquiries about whether specific apparatus is controlled and what licensing is required.

**Disclaimer:** Educational resource only. Radiation Ordinance licensing requirements depend on specific equipment characteristics. Contact the Hong Kong RPS (Radiation Protection Section, Department of Health) directly or consult a qualified radiation safety expert for equipment-specific licensing requirements.

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