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.
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