Medical Technology Association of India, which represents leading research-based medical technology companies with significant investments in manufacturing, today, welcomed two CDSCO notices which address operational and regulatory challenges faced by the medical device industry.
MTaI had apprised the Central Drugs Standard Control Organization (CDSCO) regarding the issues faced in the SUGAM portal in the post approval change (PAC) submission in changing the name or address of the authorized agent and the challenges in procuring notarized documents for medical devices and site registration due to the current pandemic situation. CDSCO has published two notices on August 31, 2020 to address these issues.
“With India entering Unlock 4.0, normal medical device business is resuming very slowly. This pace is further slowed because of the several operational bottlenecks which continue to impede smooth functioning of business. In these conditions, it is reassuring that CDSCO has taken cognizance of the challenges faced by the medical device industry and expeditiously moved to resolve them. This will undoubtedly further the cause of ease of doing business in the country” said Mr Choudary, Director General, MTaI.