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Medical Device Registration and Approval in Palestine
General country-specific regulatory information is provided on this page for medical device registration and approval in Palestine.
Last updated on November 24th, 2021.
Medical Device Regulations and Classification in Palestine
REGULATORY AUTHORITY: Medical devices are regulated by the Drug Registration Department under the General Administration of Pharmacy.
CLASSIFICATION SYSTEM: Classification follows the EU model of risk-based classification into Classes I, IIa, IIb, III, and IV.
TIMEFRAME: The approval process takes 30-60 days.
LICENSE VALIDITY: Licenses are valid for a period of five years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required.
For detailed device-specific compliance information for each market, including Palestine, to expedite the preparation of your medical device or IVD registration application.
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