Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksDoes my medical device need Nuclear Safety and Radiation Protection Regulations — Radiation Protection Board in Malta?
Describe your device to check whether Nuclear Safety and Radiation Protection Regulations — Radiation Protection Board may apply, why, what facts are missing, and which official source to review.
1 maintained routes1 official source links
Preliminary applicability · country-specific scope
What you receive
Not just a yes or no
A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.
Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.
Official starting points. Open the regulator or government sources behind the maintained country matrix.
Maintained country rule
What this Nuclear Safety and Radiation Protection Regulations — Radiation Protection Board check is screening
Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies to the facility, operator, or installation rather than only the product.
Source association reviewed. The source association has been reviewed. This does not verify every rule, date or product-specific conclusion; read the cited provisions and their limits.
- Requirement family
- Ionizing radiation and radioactive sources
- Regulatory object
- radiation equipment source and use site
- Maintained rule status
- mandatory for use site
- Useful product facts
- X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.
Malta's radiation instrument is the Nuclear Safety and Radiation Protection Regulations, S.L. 365.15 (L.N. 44 of 2003, as amended by L.N. 173 of 2004, L.N. 425 of 2007, Act XV of 2009, L.N. 426 of 2012, L.N. 210 of 2018 and Act XXXIII of 2024). Part III establishes the Radiation Protection Board with the power to receive notifications and issue authorisations; Parts IV to XIV were deleted by L.N. 210 of 2018; Part XV then places the operating duties on the radiation employer — regulation 60 makes the employer responsible for the safety of sources from acquisition to final disposal, regulation 61 requires the employer, with suppliers, to ensure on procurement that equipment containing a radiation generator conforms to the international standards the Board approves and is tested against them, and regulations 62 and 63 govern accounting for and keeping of radioactive substances. Because Parts IV to XIV (regulations 17 to 59) were deleted by L.N. 210 of 2018, the former notification regulations 17 and 18 no longer exist in the instrument, although the schedule headings still refer to regulation 17. The instrument carries the note that it has been transferred to Cap. 653 as S.L. 653.05 (Act XXXV of 2025), so S.L. 365.15 is its historic number. The regime therefore bites at the Maltese site where the equipment is held and used, not as a device-level pre-market certificate and not as a Medicines Authority function.
How to read the answer
Classification is only the first layer
A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.
Dossier or import evidence
Testing can belong inside the medical dossier, while some documents apply to each shipment.
Site or operator licence
Radiation, installation, use, or measurement controls may apply to a facility or operator.
Country-specific scope
Other Malta routes to check
Electrical safety
Medical and radiology electrical equipment outside the Low Voltage Regulations
Evidence is normally handled inside the medical-device registration route.
Source association reviewed
EMC
Electromagnetic Compatibility Regulations and the MCCAA as market surveillance authority
Evidence is normally handled inside the medical-device registration route.
Source association reviewed
Wireless / radio
Radio Equipment Regulations — MCCAA market surveillance in coordination with the MCA
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Environmental / battery
Restriction of Hazardous Substances Regulations — MCCAA competent authority
Evidence may be required, but the matrix does not identify a generic separate certificate.
Source association reviewed
Environmental / battery
WEEE producer responsibility under the Environment and Resources Authority
Maintained as a mandatory pre-market route.
Source association reviewed
Environmental / battery
Battery producer registration under Regulation (EU) 2023/1542 Chapter VIII
Maintained as a mandatory pre-market route.
Source association awaiting review
Reviewed source associations
Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.
About this checker
A preliminary tool, not a regulatory determination
Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained Malta scheme matrix and links each route to its maintained source associations, with reviewed, candidate and unresolved states shown separately.
Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.
- Is this the same as medical device classification in Malta?
- No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
- Does “no separate certificate” mean no testing is required?
- No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
- Is the result an official regulatory determination?
- No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
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