Medical Technology Association of India represents research-based medical technology companies with significant investments in manufacturing, welcomes 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 31st August’2020 to address these issues.
Pavan Choudary, Director General, MTaI said: “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 the smooth functioning of the 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.”
