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 are in the process of obtaining our MDEL from Health Canada. 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)
During the MDEL approval period, Class I medical devices may be 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 |
🔬 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?
- Regulatory Compliance First — We prioritize regulatory compliance above everything
- Direct Sourcing — No middlemen, just quality manufacturers
- Canadian Stock — Toronto warehouse, fast delivery
- Quality System — 6 SOPs covering full product lifecycle