Egypt will begin requiring registration of IVD reagents

The Egyptian Drug Authority (EDA) has announced (link in Arabic) that it will begin requiring registration for IVD reagents. Implementation of this new requirement will proceed according to the following schedule:

• July 1, 2021: deadline for local Egyptian manufacturers to submit a registration file to the EDA
• January 1, 2022: deadline for manufacturers of imported IVD reagents classified as List A or List B to obtain a marketing license from the EDA
• January 1, 2023: deadline for manufacturers of imported IVD reagents classified as General/Other or Self-Testing to obtain a marketing license from the EDA

Additionally, as of April 1, 2021, the requirement to obtain an import permit from the EDA for importation of IVD reagents will be strictly enforced. Notably, the announcement only refers to "reagents," and other IVD equipment, instruments, software, etc. are not addressed.

EDA publishes regulation on IVD reagents and unveils new website

The EDA has also published a regulation in Arabic dealing with the registration and circulation of IVD reagents.

An additional item of note is that the EDA has developed a new website. As of this time, several sections of the website, including that on medical devices, are listed as under construction.

Medical device and IVD resources for Egypt and the Middle East from Emergo by UL:

• Obtaining a Certificate to Foreign Government (CFG) from the US FDA
• Certificate of Free Sale (CFS) for medical device exports
• Whitepaper: Medical device registration in Saudi Arabia

Related resources: 

• Egypt Medical Device Regulations

Related services for Worldwide:

• 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