Medical device and equipment sourcing
Equipment is a longer commitment than consumables. What arrives with it, and what documentation stands behind it, decides whether it is an asset or a stranded cost.
NJMC sources medical devices and equipment for hospitals and clinics, confirming risk classification, ISO 13485 certification of the manufacturing site, IEC 60601 electrical safety evidence where applicable, and what the quoted price includes before a purchase order is issued.
A device that arrives without the certification your health authority expects is not a bargain. It is capital sitting in a store room while somebody works out whether it can be registered at all. Because equipment is bought infrequently, buyers often have less internal expertise here than in consumables, and suppliers know it.
Classification comes before everything
Devices are grouped by risk, and the classification determines how much evidence a regulator expects. A low risk instrument and an active implantable device are not assessed on the same terms. Establishing the class for your destination market is the first step, because it defines the entire evidence package. Get it wrong and you assemble the wrong file, which costs time rather than saving it.
What we confirm before an order is placed
- Which certification the unit carries and whether it is accepted in the destination market, rather than accepted somewhere.
- Quality system. ISO 13485 for the manufacturing site, and a technical file that actually exists rather than one that is promised.
- Electrical safety. IEC 60601 series evidence for electro-medical equipment, appropriate to the device type.
- What the quoted price includes. Accessories, consumables, installation, calibration and training are commonly quoted separately and assumed to be included.
- Spare parts and consumables over the working life. A unit that cannot be maintained locally has a much shorter effective life than its warranty suggests.
- Warranty in practice. Not the wording, but how a claim would actually be handled across a border.
What we source
Devices and equipment for hospital, clinical and laboratory use, sourced against your specification and your market's requirements.
Sequence matters more than negotiation. Buyers commit to a supplier, agree a price, then discover the certification on offer does not support registration in the destination market. By then the leverage to change supplier is gone. Establish what the market requires first, then shortlist against it. Our article on SFDA registration works through this for the Saudi market.
Frequently asked questions
What determines how much documentation a device needs?
Risk classification. Devices are grouped by risk and the class determines the evidence a regulator expects. Establishing the class for your destination market is the first step because it defines the whole evidence package.
What is commonly excluded from an equipment quotation?
Accessories, consumables, installation, calibration and training are frequently priced separately and assumed to be included. Spare parts availability over the working life is the other common omission.
Which standards apply to electro-medical equipment?
ISO 13485 for the manufacturing site's quality system, and the IEC 60601 series for electrical safety, with the specific parts depending on the device type.
Related pages
Tell us what you need to source
Send the product or molecule, the grade, the quantity and the destination market. You will get a considered answer about what can be sourced and what documentation comes with it.