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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