Ministry of Public Health (وزارة الصحة العامة) — the device file is handled by the Health Technology Unit (unité des technologies de la santé) with the Health Engineering Service (Département de génie sanitaire / مصلحة الهندسة الصحية) and the Pharmacy Service's Import/Export department, the implantable registration request is lodged with the Department of Programs and Projects (دائرة البرامج والمشاريع) under Decision 455/1 Art. Six, and the entry permit is granted by the Health Engineering Service under Art. Four (Ministry of Public Health) review clocks and planning ranges · 4 national levels — Low risk, Low-To-Moderate, Moderate-To-High and High — set by Decision 1506/1 of 1 September 2014 Art. Three and mapped band-by-band to the EU (I, II-a, II-b, III), US (I, II, —, III), Japanese (I, II, III, IV), Australian (I, I-m/II a/Is, II-b, III), Swiss (I, II-a, II-b, III) and Canadian (I, II, III, IV) classes, with GMDN classification and coding under Art. Two classification
| Class / pathway | Review clock | Planning total | Provenance |
|---|
| Entry and import approval for medical devices, instruments and supplies of all risk levels — form MPH12-26(Application on the official form to the Ministry of Public Health with the device invoice, the specifications catalogue and the letter of the beneficiary, together with the Atomic Energy Authority's import approval where the request calls for it; the invoice must bear the Atomic Energy stamp, the conformity certificate is issued by the Industrial Research Institute, and the Health Engineering Service then grants the entry permit) | 7-14 days | 1-2 months | Verified↗ |
- 1Pre-Submission Preparation(1-3 months)→
- 2Application Submission(1-2 weeks)→
- 3Administrative Review(2-4 weeks)→
- 4Technical Evaluation(7-14 days)→
- 5Registration Approval(1-2 weeks)