Egypt Medical Device Regulations
Log into RAMS to download the documents listed below along with more regulations and guidances for Egypt.
Related services
- Certificate of Free Sale (CFS) for Medical Device Exports
- Certificate to Foreign Government (CFG) for medical devices
- Clinical Trial Management for Medical Devices
- Customized Regulatory Pathway Reports for Smaller International Markets
- ISO 13485 Auditing | Medical Device Internal Audits
- ISO 13485 Consulting and Certification
- ISO 13485:2016 Gap Analysis and Transition
- ISO 14971 Medical Device Risk Management
- ISO 14971 Medical Device Risk Management Training
- Medical Device Quality Assurance and Regulatory Affairs Outsourcing
- Medical Device Representative for In-Country Representation
- Medical device software and mobile app regulatory consulting
- Quality Management System (QMS) Compliance for Medical Device Startups
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Prime Minister’s Decision No. 777 of 2020 | 777 | 2020 | |
| Log in | Law No. 151 of 2019 | 151 | 2019 |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | Regulation for the Registration and Circulation of Laboratory and Diagnostic Reagents |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Log in | The Egyptian Guideline for Medical Device Vigilance System |
