Medical Technology Association of India (MTaI) has welcomed two CDSCO notices which address operational and regulatory challenges faced by the medical device industry.
As per a release, MTaI had apprised the Central Drugs Standard Control Organisation (CDSCO) regarding the issues faced in the SUGAM portal in the post approval change (PAC) submission in changing the name or address of the authorised agent.
The association had apprised the challenges in procuring notarised documents for medical devices and site registration due to the current pandemic situation. CDSCO had 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 cognisance 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 Pavan Choudary, director general, MTaI.