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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Palestine, to expedite the preparation of your medical device or IVD registration application.

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.

Last updated on January 29 2015.

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