Europe
Speed and documentation
- Typical lead time
- 6–14 weeks for instruments. The lead time here is set by the manufacturer's production plan, not by the freight.
Supplies
Every line arrives with the document the committee asks for.
Medical and laboratory equipment
The group with the strictest regulatory regime. This is not only about delivery — it is about registration, staff training and guaranteed service for the whole warranty period.
What we supply
If your item is not on the list, send it anyway — the list is a guide, not a limit.
What is in this group?
- Hospital equipment
- beds, trolleys, operating tables, lights
- Diagnostic equipment
- ultrasound, ECG, patient monitors
- Laboratory instruments
- centrifuges, microscopes, autoclaves, incubators
- Sterilisation equipment
- autoclaves, dryers, sealing machines
- Healthcare furniture
- treatment units, laboratory benching, medicine cabinets
- Consumables
- to the specification of the contract
Standards
The standard in the BoQ decides what can and cannot be delivered.
Which standards prove conformity?
We check which standard is written into the contract documents and confirm in writing that what we propose meets it. Where the written requirement does not exist on the market in that form, we say so before ordering, not after delivery.
- Regulation (EU) 2017/745 (MDR)
- Medical devices. Sets classes I, IIa, IIb and III and the obligations of manufacturer and importer.
- BDS EN 60601
- Medical electrical equipment — general requirements for basic safety and essential performance.
- BDS EN ISO 13485
- Quality management systems for medical devices.
- Bulgarian Medical Devices Act
- Requires the devices and the trader to be entered in the Bulgarian Drug Agency register.
- BDS EN ISO 15189
- Medical laboratories — requirements for quality and competence.
Documents
A missing document is declared missing.
Which documents does the acceptance committee receive?
- EU declaration of conformity and a CE certificate from a notified body according to class
- Instructions for use in Bulgarian
- Proof of registration under the Bulgarian Medical Devices Act
- Warranty terms setting out the service arrangement and response time
- Commissioning record and staff training record
The documents arrive with the goods, organised line by line. We do not go looking for them once the committee asks.
Lead times
Indicative. A binding deadline is given only in a written quote.
Europe or Asia — which makes sense for this group?
Asia
Price and volume
- When it makes sense
- Only for furniture and consumables, and only with a manufacturer that already holds a valid CE certificate for the European market. We do not take on devices whose documentation would have to be created from scratch.
Getting started
What should you send to get a quote?
- The technical specification from the contract documents
- Device class, where stated
- Training and service requirements
- The commissioning date
Send the items and you will get a concrete answer within 48 hours. We charge the contractor nothing — our margin sits with the manufacturer.
Send an enquiry
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