ABSTRACT
New regulations for medical devices were introduced in 1917 and came into effect in January 1918. These regulations encompassed the evaluation process, execution, and online involvement, all of which were authorised by the regulatory framework. The classification of medical devices was established based on the associated risk of use, and specific data requirements were assigned to each classification. To ensure compliance, the responsibility for monitoring the registration of medical devices posing a low to moderate risk was granted to the State Licensing Approval Authority (SLA), while the CLA was entrusted with overseeing devices that posed a moderate risk or higher. The registration process necessitated the provision of comprehensive information regarding the device, including pre-toxicity assay results, analytical validation data, and details of any clinical trials conducted. This chapter delves into the finer details of the procedures and regulations governing the registration of medical devices.
