Key data
| Regulation | Resolution of 8 July 2026, from the General Directorate of Energy Planning and Coordination |
|---|---|
| Publication | 31 July 2026 |
| Entry into force | 31 July 2026 |
| Affected parties | Companies importing, distributing and using X-ray inspection equipment in Spain |
| Category | Energy / Radioactive equipment |
| Modified type approval | NHM-X393 |
| Authorized model | PRO 6.4 (Shanghai Fjade Technology Co., Ltd.) |
| Authorization holder | Prosescan SA |
| CSN Report | Favorable, issued on 6 July 2026 |
| Maximum permitted dose | 1 μSv/h at 0.1 m from the surface |
| Mandatory maintenance | Annual, by authorized company |
Companies operating X-ray inspection equipment in Spain have had a new homologated model in their catalog since 31 July 2026: the PRO 6.4 from Shanghai Fjade Technology Co., Ltd. The Resolution from the General Directorate of Energy Planning and Coordination modifies type approval NHM-X393, held by Prosescan SA, to incorporate this model intended for parcel inspection.
The Nuclear Safety Council issued a favorable report on 6 July 2026, just three weeks before official publication. The resolution enters into force on the same day as its publication in the BOE, with no transitional period.
What does this regulation establish?
The resolution authorizes the modification of type approval NHM-X393 to include the PRO 6.4 model within the range of X-ray generators from Shanghai Fjade Technology Co., Ltd. marketed in Spain by Prosescan SA. These are equipment intended exclusively for parcel inspection.
The technical and documentary requirements that these equipment must meet are as follows:
| Requirement | Detail |
|---|---|
| Equipment marking | Mandatory indelible marking |
| Dose limit | Maximum 1 μSv/h at 0.1 meters from the surface |
| Documentation | Complete and in Spanish |
| Maintenance | Annual, performed by authorized company |
| Records | Documented periodic checks |
| Safety systems | Correct operation guaranteed by the user company |
| Signage | Correct and operational, responsibility of the user company |
A critical aspect that the resolution makes clear: type approval is not sufficient in itself to manufacture, market or provide technical assistance on this equipment. Each of these activities requires additional and independent authorizations.
Economic and operational impact
For companies using the PRO 6.4 equipment, the most immediate impact is operational: they must ensure continuous compliance with technical requirements and maintain documented records of checks. The most recurring and predictable cost is that of mandatory annual maintenance, which must be contracted with a company expressly authorized to do so.
For companies distributing or importing that want to market the PRO 6.4 in Spain, the updated NHM-X393 type approval is a necessary but not sufficient step: they will need to process the corresponding additional authorizations before they can operate commercially with this model.
For companies that already had other Shanghai Fjade models under NHM-X393 approval, this modification expands the available catalog without affecting the conditions of already authorized equipment.
Who does it affect?
- Companies using X-ray inspection equipment: airports, logistics centers, port facilities, private security companies and any operator using parcel scanners.
- Importers and distributors of X-ray equipment: especially those working with the Shanghai Fjade brand or with Prosescan SA as intermediary.
- Radioactive equipment maintenance companies: those providing authorized technical service to operators of this equipment.
- Safety and compliance managers in facilities with X-ray equipment: must update their internal procedures to include the PRO 6.4 model if they incorporate it.
Practical example
A private security company managing access control at a fairground decides to incorporate the PRO 6.4 model from Shanghai Fjade for parcel inspection at its facilities. Before putting it into operation, it must verify that the equipment bears the indelible marking required and that the technical documentation is entirely in Spanish.
Once in operation, the company must contract annual maintenance with an authorized company and maintain an updated record of all periodic checks performed on the equipment's safety systems and signage. If any inspection measures a dose exceeding 1 μSv/h at 0.1 meters from the surface, the equipment does not meet requirements and must be removed or repaired immediately.
If that same company also wanted to distribute the PRO 6.4 to third parties, type approval NHM-X393 does not authorize it to do so: it would need to process an additional specific authorization for commercialization.
What should companies do now?
- Verify if they use or plan to use the PRO 6.4 model: if it is already in use or its incorporation is planned, verify that it meets all technical requirements of the updated NHM-X393 approval.
- Check the equipment marking and documentation: the marking must be indelible and all technical documentation must be available in Spanish.
- Contract annual maintenance with an authorized company: schedule the first maintenance now if the equipment is in use, and ensure that the provider has the corresponding authorization.
- Establish records of periodic checks: implement an internal procedure to document each verification of safety systems and signage.
- Verify that the dose does not exceed 1 μSv/h at 0.1 m: include this measurement in periodic check protocols.
- If you want to manufacture, market or provide technical assistance: process the necessary additional authorizations, as type approval NHM-X393 does not authorize any of these activities by itself.
Frequently asked questions
What is type approval NHM-X393 and what does it now include?
Type approval NHM-X393 is the official authorization that allows the marketing and use of X-ray generating equipment from Shanghai Fjade Technology Co., Ltd. in Spain. With the Resolution of 8 July 2026, it has been modified to include the new PRO 6.4 model, intended for parcel inspection.
What is the maximum permitted dose for the PRO 6.4 scanner?
The PRO 6.4 equipment must comply with a maximum dose of 1 μSv/h measured at 0.1 meters from the equipment surface. This limit is a mandatory technical requirement included in the authorization resolution.
How often must the PRO 6.4 scanner be maintained?
Maintenance is mandatory with annual frequency and must be performed by an authorized company. Additionally, user companies must keep records of all periodic checks performed.
Does type approval already allow manufacturing or selling the PRO 6.4 equipment in Spain?
No. Type approval does not by itself authorize manufacturing, marketing or providing technical assistance on the equipment. These activities require additional and independent authorizations from type approval.
What documentation does the regulation require for the PRO 6.4 scanner?
The regulation requires complete documentation in Spanish, indelible marking on the equipment and records of periodic checks. User companies must also ensure the correct operation of safety systems and signage.
Official source
Consult complete regulation at official source
Notice: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2026-16731