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Activities regulated by the Central Licensing Authority:
Enforcement of rules in matters related to:
• import of all Classes of IVDs.
• Manufacture of Class C and Class D IVDs.
• clinical performance evaluation and approval of new in vitro diagnostic.
• Registration of Notified Bodies
• Registration of Laboratories for carrying out test or evaluation.
Test licences for manufacture or import of all classes of IVDs
Activities regulated by the State Licensing Authorities:
Enforcement of rules in matters related to:
• manufacture for sale or distribution of Class A or Class B IVD
• Sale, stock, exhibit or offer for sale or distribution of IVDs of all classes.