Egypt and Thailand: Two Routes to Medical Device Market Access

Egypt is one of the largest and most import-dependent device markets in the MENA region, and its regulatory system is built around one authority and one borrowed framework. The Egyptian Drug Authority (EDA) was established under Law No. 151 of 2019 and reports directly to the Prime Minister. Device oversight rests on Egyptian Medical Device Law No. 10 of 2003, supplemented by EDA guidelines. Registration has been mandatory since September 2018. Egypt has no classification scheme of its own. It generally follows the classification a device already holds in a reference market, most commonly the EU framework of Class I, IIa, IIb, and III. Manufacturers outside Egypt must appoint a local agent, the Egyptian Registration Holder (ERH), to submit applications and dossiers to the EDA on their behalf, and the expected quality system standard is ISO 13485. Labeling is relatively accommodating: EDA guidance allows Arabic or English, provided intended users can readily understand it. Procedures also keep changing. The EDA updated its registration procedures on 12 February 2026. One practical point for planning: one provider quotes 6 to 18 months depending on device class, so timelines should be confirmed with your ERH early.

Thailand is more structured and closely tied to ASEAN. As the Thai FDA medical device regulation overview on ElendiLabs explains, the Medical Device Control Division of the Thai FDA, under the Ministry of Public Health, is the primary regulator. It works under the Medical Device Act B.E. 2551 (2008), amended in 2019, and is harmonized with the ASEAN Medical Device Directive. Thailand uses four risk classes and ties each to a pathway: Class 1 devices are listed, Class 2 and 3 are notified, and Class 4 devices need a full license. Class 2, 3, and 4 devices follow one of three routes, which are full evaluation, abridged, or reliance. The reliance route is available for devices already approved by Singapore’s HSA, and the submission must match the CSDT file filed there. The main similarity with Egypt is the need for local representation, since both countries require a locally based entity to hold the registration. The differences are in scale and design. Egypt borrows its classification from the EU and sets few language barriers, whereas Thailand runs its own ASEAN-aligned classification and layers establishment licensing on top. Home-use devices must carry Thai-language labeling, while English is acceptable for professional-use devices. Thailand is also accelerating regional cooperation, including the Malaysia–Thailand reliance pilot launched in December 2025. For manufacturers, Egypt rewards strong EU documentation, while Thailand rewards early planning around classification, grouping, and an ASEAN-ready dossier.

References:

1- Egypt EDA Medical Device Registration Guide (2026): Process, Fees & Timeline https://meddeviceguide.com/blog/egypt-eda-medical-device-registration-guide-2026

2- Egypt Medical Device Registration Overview https://www.freyrsolutions.com/medical-devices/medical-device-registration-in-egypt

3- Medical Device Regulations and Registration Process in Egypt https://www.artixio.com/post/medical-device-regulations-registration-egypt

4- Product Registration for Medical Devices in Egypt https://taevasglobal.com/egypt/medical-devices/product-registration

5- Medical Device & IVD Regulations In Thailand https://www.pureglobal.com/markets/thailand/thailand-medical-device-and-ivd-regulations

6- New Medical Device Regulations in Thailand https://www.freyrsolutions.com/blog/new-medical-device-regulations-in-thailand