The Central Drugs Standard Control Organisation (CDSCO) has classified about 80 in-vitro diagnostic (IVD) health-related devices below Medical Device Rules (MDR) -2017 based on danger based classification for their efficient regulation.
“This will help companies in effective compliance to MDR-2017 with respect to the import, manufacture, clinical investigation, clinical performance evaluation, sale and distribution of medical devices,” stated Dr V G Somani, Drugs Controller General of India (DCGI).
According to the new MDR guidelines, Class A is for low danger, Class B for low moderate danger, Class C for moderate higher danger and Class D for higher danger.
Around 80 IVD health-related devices have been classified below the MDR 2017 based on the intended use, danger connected with the device and other parameters. These 80 classified devices are covered below categories of clinical chemistry, hematology category, immunology and microbiology amongst other individuals for efficient regulation and patient security.
“This list is dynamic and is subject to revision from time to time under the provisions of the MDR – 2017,” the DCGI additional stated.
New MD Rules 2017 covers health-related devices, in-vitro diagnostics (IVDs), disinfectants, surgical sutures, ligature, condoms, bandages and so forth. It sets new requirements for manufacturing and use of health-related devices.
Around 20 devices in the clinical chemistry category, 13 in the hematology category, 8 in immunology category and 7 in microbiology categories such as 53 IVD analysers have been classified.
The new MD Rules 2017 have been notified last year and came into impact from January 1, 2018 onwards in the nation. Following the notification, problems connected to post grant compliance, information protection, item recalls and item liabilities amongst other individuals will be implemented efficiently towards device or item security.
State Licensing Authorities (SLAs) have to send applications to the notified bodies for inspections and auditing of Class A and Class B category health-related devices towards compliance to the new MD Rules. Class C and Class D categories are audited by the CDSCO independently as per the new MD Rules.
The notice says that the computer software, which drives a device or influences the use of a device, falls automatically in the exact same class. Software that is not incorporated in an IVD health-related device, shall be classified applying the classification provisions as specified in the relevant portion of MDR -2017.
The Central Government, immediately after consultation with the Drugs Technical Advisory Board (DTAB) had notified MDR- 2017 effective from January 1, 2018.