Medical & healthcare products
The intended medical purpose and manufacturer’s claims should be established at the start of the review.
Request a product review ↗Products to discuss during review
- Healthcare equipment
- medical devices
- medical-use products
These examples illustrate the category. The exact HS code, product description and any exemption determine how the shipment is treated.
Information worth gathering
- Intended-use statement
- manufacturer and model details
- available regulatory records
- technical evidence
This is preparation advice, not a universal mandatory-document or test list. Share available records first and explain any gaps.
Resolve these questions early
Confirm whether separate health-sector registration or import permissions apply. Do not assume a CoC provides permission to market every medical product.
The applicable standards, accepted editions, testing scope and final evidence list must be confirmed for the exact product. Registration, licensing and exemption eligibility are also assessed individually.
How we help
GoCertify helps organise your file, identify questions for the assessment body and coordinate the next steps. The authorized body evaluates conformity and makes the certification decision.