MTaI welcomes CDSCO notice addressing challenges and furthering Ease of doing business for medical device sector

Mumbai, September 2, 2020: 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.

About Medical Technology Association of India (MTaI) : Medical Technology Association of India (MTaI– pronounced as Em-tai) is a not-for-profit organization duly registered under sub-section (2) of section 7 of the Companies Act, 2013 and Rule 8 of the Companies (Incorporation) Rules, 2014.

 MTaI is an association of research-based medical technology companies who have made remarkable investments in Manufacturing, R&D and Health Care Workers Training in India. MTaI represents a wide spectrum of the medical device industry with global experience in innovation and manufacturing. All the time stressing on the three hallmarks of healthcare – Quality, Consistency and Patient Safety, MTaI wants to be a responsible voice of the industry. The association is committed to improving access to affordable and quality healthcare for patients.

MTaI looks to partner with the Government of India in setting a roadmap for the growth of medical devices sector by bringing in even bigger investments in this sector, through ‘Make in India’ and through technology upgradation and dissemination in the provider space.