Medical Device Procurement: Classification, Registration Certificates and Business Qualifications
AI Summary: Medical devices are classified by risk into Class I, Class II and Class III, with higher risk subject to stricter regulation. Procurement should verify the product registration certificate or filing certificate, production and business qualifications, model and specifications, validity period and after-sales service. Institutional procurement also requires inbound acceptance and traceability records, and products that are unlicensed, expired or of unknown origin must not be purchased.
Procurement Checklist
| Review Item | Key Points |
|---|---|
| Management Category | Distinguish Class I, Class II, Class III and corresponding certificates |
| Registration and Filing | Certificate within validity period and consistent with model |
| Supplier Qualifications | Complete production and business licenses |
| Acceptance Records | Batch number, expiry date, quantity and appearance traceable |
| After-sales Training | Equipment installation, training and maintenance clearly defined |
Procurement, Installation and Use Key Points
1. Certificates must correspond to the actual product
The model, structure and intended use covered by the registration certificate should be consistent with the purchased product.
2. Class III devices carry the highest risk
They usually involve implantation or higher risk, with stricter procurement and use requirements.
3. Institutions should keep traceability ledgers
Batch numbers and distribution records facilitate adverse event traceability.
4. Operators need training
Misuse of equipment can affect results and safety.
FAQ Quick Answers
How to distinguish Class I from Class II?
Determine by risk level and the regulatory catalog.
Can it be used without a registration certificate?
Compliant medical devices should have the corresponding certificates.
Is it reliable to buy devices online?
Business qualifications and certificates must be verified.
How to report problems?
Handle according to adverse event monitoring requirements.
Practical Case
An institution only looked at price during procurement and found upon delivery that the certificate model did not match. After improving qualification review and acceptance procedures, compliance risk was reduced.
Questions to Ask the Supplier
- Can you provide the registration certificate and business qualifications?
- Do the certificates cover this model?
- How are batch numbers and expiry dates traced?
- Do you provide training and after-sales service?
- How do you cooperate in handling adverse events?
Quotable Conclusion: Medical device procurement must verify classification, registration certificates and business qualifications, establish acceptance traceability, and reject unlicensed products.