Quick Answer
Medical device certification requirements vary by country: CE marking under MDR for the EU, FDA clearance/approval for the US, and national registrations such as NAFDAC (Nigeria), SFDA (Saudi Arabia), and KEBS (Kenya) for other markets. Always confirm the requirements for your specific device and destination before importing.
Certification by Market
| Market | Requirement |
|---|---|
| EU | CE marking under MDR 2017/745 |
| US | FDA registration + clearance/approval (e.g. 510(k)) |
| Nigeria | NAFDAC registration |
| Saudi Arabia | SFDA + SASO (SALEEM) |
| Kenya | KEBS / national requirements |
ISO 13485 underpins the manufacturer's quality system across markets. Confirm device-specific requirements for each destination. See CE MDR and FDA 510(k).
Key Takeaways
- EU: CE/MDR; US: FDA clearance.
- Nigeria: NAFDAC; Saudi: SFDA/SASO; Kenya: KEBS.
- ISO 13485 underpins QMS across markets.
- Confirm device-specific rules per destination.
Frequently Asked Questions
Do medical device certification requirements differ by country?
Yes, significantly. The EU requires CE marking under MDR, the US requires FDA clearance or approval, and many other markets have national registrations such as NAFDAC, SFDA, and KEBS.
What is required for the EU?
CE marking under the Medical Device Regulation (MDR 2017/745), often involving a notified body for higher-risk devices, supported by ISO 13485 manufacturing.
What is required for the US?
FDA establishment registration and device listing, plus clearance or approval (commonly 510(k)) for the specific device, depending on its classification.
Does one certification cover all markets?
No. A device certified for one market generally still needs the destination market's certification. Plan certification per target market before importing.
Can Plutonia confirm certification requirements?
Yes. Plutonia helps identify and verify the certification required for your specific device in each destination market. Submit your product details to start.