Medical devices: compliance without compromise.
Medical leaves no room for approximation or improvisation. Our division selects ISO 13485-certified factories, verifies every regulatory file (MDR, FDA, UKCA) and secures your supply chain.
- Reply within 2 business days
- No commitment
- NDA on request
A medical device is first and foremost a regulatory file.
Expired ISO 13485 certificate, incomplete MDR technical file, no 510(k), untraceable batch: in medical devices, the importer carries a heavy liability.
Our teams, as close to the factories as possible.
Our medical category, led by a former regulatory affairs manager at a device manufacturer, works only with ISO 13485 certified factories whose certificates are verified at source, audits their quality systems and traceability, prepares or verifies documentation (MDR class I and IIa, CE marking with a notified body, FDA 510(k) or exemption, UKCA) and inspects every batch with tightened sampling plans. Hubs: Zhejiang (consumables, syringes, dressings), Guangdong (medical electronics, thermometers, blood pressure monitors), Jiangsu (medical furniture, orthopedics), Shandong (PPE).
What we source in this category.
- Examination gloves, syringes and bandages
- Surgical masks and gowns
- Blood pressure monitors, pulse oximeters and thermometers
- Rapid diagnostic tests
- Hospital beds and examination tables
- Wheelchairs and walkers
- Orthopedics and rehabilitation
- Surgical and dental instruments
- Incontinence and underpads
- Laboratory furniture and fume hoods
- Laboratory glassware and consumables
- Centrifuges, ovens and microscopes
- Veterinary equipment
What we take care of.
Certificates verified with the certification bodies, quality system and traceability audits.
MDR (EU), UKCA, FDA (510(k), establishment registration), Health Canada; technical file and person responsible.
Biocompatibility, sterility, performance to ISO/EN standards, accredited laboratories.
Lots, UDI, record retention, recall procedures.
Tightened AQL, systematic functional testing on electronic devices, labeling checks.
Validated packaging, controlled storage and transport conditions.
How we work.
Classification & requirements
Device class, applicable standards, requirements of each target market.
Certified sourcing
Audited ISO 13485 factories, verification of existing files, side-by-side quotes.
Qualification
Samples, testing, review or compilation of the technical file, regulatory approval.
Production & monitoring
Enhanced inspections, traceability, post-market surveillance with you.
Frequently asked questions.
Do you source Class IIb or III devices?
Case by case, together with your notified body; our core focus is Class I and IIa and consumables.
Can you be our authorized representative?
No, but we point you to authorized representatives (EU Authorized Representative, UK Responsible Person) and prepare the file with them.
Do you handle PPE?
Yes: PPE Regulation 2016/425, categories I to III, tests and certificates verified.
In the same family, other categories.
Hospitality & foodservice
Commercial kitchen equipment, commercial refrigeration, hotel and patio furniture, linens, tableware, playgrounds and sports equipment.
View the categoryWorkplace safety
Gloves, safety footwear, workwear, fall protection, fire safety, signage: EN and ANSI lab testing.
View the categoryA product to manufacture? Get an initial costed analysis.
Describe your product and volumes: a project manager from your industry replies with feasibility, the relevant manufacturing hubs and an indicative landed cost.
- Reply within 2 business days
- NDA on request
- Dedicated project manager