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Latvia - who.int
LatviaWorld Bank income group: High incomeLegal Legal framework: YesAuthorizing legislation: Pharmaceutical Law (19 March 1998) (as amended) The Cabinet of Ministers regulation Medical devices for human clinical trial procedure (21 September 2010) Regulation No. 581 (2 August 2005) Procedures for Registration, Conformity Assessment, Distribution, Operation and Technical Supervision of Medical Devices : Registration of medical devices, conformity assessment, distribution, operational and technical supervision procedure Regulatory AuthorityNational Regulatory Authority present: YesName: State Agencies of Medicines of the NRA: The Agency, with regard to medical devices, must: - perform conformity assessment and registration - establish and update the register of medical devices - issue permits for the performance of clinical investigations - supervise the safety and use of medical devices - create and maintain a database on observed adverse reactions caused by medical devices Pharmaceutical Law, para.
WHO European Region Clinical investigation Clinical investigation controls: Yes Details: Clinical trials are regulated pursuant to Regulation No. 891.
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