Certifications
QUALITY & COMPLIANCE
Certifications Available Across Our Factory Network
SAFE CAREMED sources from certified factories across our network. CE, ISO and FDA documentation is available per product and verified before every shipment.
What “Certified” Means Here
SAFE CAREMED is a sourcing and export partner — the certifications shown on this page belong to the manufacturing factories in our network, not to SAFE CAREMED itself. Availability depends on the product: we confirm which certificates apply and share verified copies before you place an order.
FACTORY CERTIFICATIONS
Certifications Held by Our Partner Factories
Each badge below is a placeholder slot — upload the factory’s real certificate or logo image to Media Library and swap it in.
CE Marking
Confirms compliance with EU health, safety and environmental requirements. Available on eligible medical devices.
AVAILABLE ON SELECT PRODUCTS
ISO 13485
Quality management standard specific to medical device manufacturing. Common across our surgical and diagnostic factories.
AVAILABLE ON SELECT PRODUCTS
ISO 9001
General quality management certification held by most factories in our network.
AVAILABLE ON SELECT PRODUCTS
FDA Registration
US FDA establishment registration and listing, available for select exportable product lines.
AVAILABLE ON SELECT PRODUCTS
SGS Test Report
Independent third-party lab testing available for raw materials and consumables on request.
AVAILABLE ON SELECT PRODUCTS
NMPA (China)
Local Chinese regulatory registration, relevant for factories manufacturing under domestic approval.
AVAILABLE ON SELECT PRODUCTS
HOW VERIFICATION WORKS
From RFQ to Verified Certificate
STEP 1
You Tell Us the Product
Send the product and destination market in your RFQ or quote request.
STEP 2
We Confirm the Factory
We match it to a certified factory and confirm which certificates apply.
STEP 3
You Receive Copies
Verified CE / ISO / FDA / test report copies are shared before you order.
STEP 4
Certificates Ship With the Order
Original or notarized documents accompany the shipment where required.
ON REQUEST
Documents You Can Request Per Order
Not every document applies to every product — confirm what’s relevant when you send your RFQ.
- CE Certificate copy
- ISO 13485 / ISO 9001 copy
- FDA registration copy
- SGS / third-party test report
- Certificate of Free Sale
- Certificate of Origin
FAQ
Certification Questions We Get Often
Need a document for a specific product? Ask us directly on WhatsApp.
Does SAFE CAREMED hold these certifications itself?
No. SAFE CAREMED is the sourcing and export partner. The certifications on this page belong to the manufacturing factories in our network, and availability depends on the specific product.
Are all products in the catalog certified?
Not automatically. Certification depends on the product category and the destination market’s requirements. Tell us the product and market and we’ll confirm what’s available.
Can you send the certificate before I pay?
We can share a verified copy of the relevant certificate once the factory and product are confirmed for your order, ahead of shipment.
What if my country requires a specific certificate you don't list here?
Send us the requirement. We’ll check with our factory network and confirm whether it can be provided or arranged for your order.
Need a Certificate Confirmed for Your Order?
Tell us the product and destination market — we’ll confirm which certifications apply before you order.