REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Malta, devices are regulated by the Malta Competition and Consumer Affairs Authority (MCCAA).
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.
TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required anywhere in the European Union.
ADDITIONAL INFORMATION: On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
Any manufacturer or EU Authorized representative who has his registered place of business in Malta and, under his own name, places devices on the market shall inform the Regulatory Affairs Directorate of his registered place of business and the description of the devices concerned.
For all medical devices of Classes IIa, IIb and III, all data allowing the identification of such devices together with the label and instructions for use, may be requested when such devices are put into service in Malta.