CDSCO publishes Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD).

The laboratory should maintain records of tests for evaluation and performance carried out on all samples of medical devices and the results thereof together with protocols of tests and the reports showing readings and calculations and such records shall be retained, in case of substances for which an expiry date is assigned, for a period of two years beyond the expiry date, and in the case of other substances, for a period of six years.

PCI opens portal to process applications for new institutions.

The pre-requisite statutory documents, incldues consent of affiliation of examining authority, No Objection Certificate of the State Government, etc., shall clearly indicate that it is for the 2022-23 academic session. The submission of these pre-requisite statutory documents is a mandatory requirement.

Government of Andhra Pradesh notifies amendments to AP Allopathic Private Medical Care Establishments (Registration and Regulation) Rules, 2007.

All Private Allopathic Medical Care Establishments i.e. Hospitals, Clinics, Diagnostic centres shall enroll under National Digital Health Mission Portal and the Registry will enable hospitals and diagnostic clinics participate in the Digital Health Ecosystem. The health care facility registry will consist of one record and a unique identifier for each healthcare facility in the Country.