Certifications & Compliance

Certifications & Compliance

CliniEco Medical is committed to meeting and exceeding Canadian healthcare regulatory standards. Our quality system is designed to ensure every product meets Health Canada requirements.

📋 MDEL (Medical Device Establishment Licence)

We hold Medical Device Establishment Licence (MDEL) #35334, issued August 24, 2026. This licence authorizes us to import and distribute medical devices in Canada in full compliance with the Medical Devices Regulations.

Our quality management system includes 6 Standard Operating Procedures (SOPs) covering:

  • Complaint Handling (SOP-01)
  • Recall Procedure (SOP-02)
  • Adverse Event Reporting (SOP-03)
  • Traceability System (SOP-04)
  • Document Control (SOP-05)
  • Supplier Management (SOP-06)

All devices we import and distribute are covered under our Health Canada MDEL (#35334), and Class I devices are sold in accordance with Health Canada regulations.

🏭 Manufacturer Certifications

All products are sourced from ISO 13485 certified manufacturers:

Supplier Products ISO 13485 MDSAP
Kingfa Medical Gloves, PLA Bags ✅ In Progress
Intco Medical Gloves ✅ ✅
Winner Medical Masks, Gowns ✅ ✅
Zhende Medical Bed Sheets, PPE ✅ In Progress
Piaoan Group Bed Sheets, Gowns ✅ In Progress

✅ Product Compliance by Category

Product Line Health Canada Class MDEL Required Standards
Nitrile Gloves Class I ✅ ASTM D6319
Face Masks ASTM L1 Class I ✅ ASTM F2299, F2100
Isolation Gowns L1 Class I ✅ ASTM F1868
Bed Sheets Class I ✅ Medical Device Standards
Underpads Class I ✅ Medical Device Standards
Waste Bags Non-device Optional O.Reg.106/21
Other Accessories Class I / Non-device As applicable Various

📋 SOP-to-Product Mapping

Each CliniEco product is supported by applicable Standard Operating Procedures (SOPs) as part of our Health Canada MDEL quality management system.

PRODUCT HC CLASS SOP-01
Complaints		 SOP-02
Recall		 SOP-03
Adverse Events		 SOP-04
Traceability		 SOP-05
Doc Control		 SOP-06
Supplier Mgmt
Nitrile Gloves Class I ✅ ✅ ✅ ✅ ✅ ✅
Face Masks ASTM L1 Class I ✅ ✅ ✅ ✅ ✅ ✅
Isolation Gowns L1 Class I ✅ ✅ ✅ ✅ ✅ ✅
Bed Sheets Class I ✅ ✅ ✅ ✅ ✅ ✅
Underpads Class I ✅ ✅ ✅ ✅ ✅ ✅
Medical Waste Bags Non-device ✅ ✅ — — ✅ —
Cotton Swabs Class I ✅ ✅ ✅ ✅ ✅ ✅
Medical Tape Class I ✅ ✅ ✅ ✅ ✅ ✅
Exam Table Paper Non-device ✅ — — — ✅ —
Oral Swabsticks Class I ✅ ✅ ✅ ✅ ✅ ✅
Specimen Cups Non-device ✅ — — — ✅ —
Tongue Depressors Class I ✅ ✅ ✅ ✅ ✅ ✅

✅ = SOP applies · — = Not applicable
All SOPs are available for review upon request from Health Canada or authorized auditors.

📋 SOP-to-Product Compliance Matrix

Each CliniEco Medical product is governed by the following Standard Operating Procedures as part of our Health Canada MDEL quality system:

PRODUCT LINE SOP-01
Complaint 		SOP-02
Recall 		SOP-03
Adverse Event 		SOP-04
Traceability 		SOP-05
Doc Control 		SOP-06
Supplier Mgmt
Nitrile Gloves ✅ ✅ ✅ ✅ ✅ ✅
Face Masks ✅ ✅ ✅ ✅ ✅ ✅
Isolation Gowns ✅ ✅ ✅ ✅ ✅ ✅
Bed Sheets ✅ ✅ ✅ ✅ ✅ ✅
Underpads ✅ ✅ ✅ ✅ ✅ ✅
Waste Bags (Non-device) ✅ ✅ — — ✅ —
Other Accessories ✅ As needed As needed As needed ✅ As needed

⬇️ Download: Full SOP Document Package (PDF) — Our complete 6-document SOP suite for MDEL compliance.

🔬 Quality Assurance

  • All products undergo visual inspection before shipment
  • Certificate of Analysis available upon request for each batch
  • Traceability system maintains lot/batch records from manufacturer to end customer
  • Annual supplier audits ensure continued compliance

Why Choose CliniEco?

  1. Regulatory Compliance First — We prioritize regulatory compliance above everything
  2. Direct Sourcing — No middlemen, just quality manufacturers
  3. Canadian Stock — Toronto warehouse, fast delivery
  4. Quality System — 6 SOPs covering full product lifecycle