December 5, 2018
Association to work with CDSCO, member companies to ensure compliance
Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies with significant investments in India, today welcomed the CDSCO proposal for inclusion of surgical gowns and drapes as medical devices and said it will ensure uniformity of quality in these product categories.
The Central Drugs Standard Control Organization last week proposed to include surgical gowns and drapes under Drugs and Cosmetics Act, 1940 which will bring these products under the regulatory framework of the government. At present, 23 medical devices such as cardiac stents, orthopedic implants, intra-ocular lenses etc. are regulated under the said Act. CDSCO has sought stakeholders’ views on the proposal by 15th January.
“The inclusion of surgical gowns and drapes would ensure uniformity in the quality of products available in the market. Gowns and drapes come into direct contact of patients as well as healthcare professionals during the entire healthcare cycle, from diagnostic procedures to postoperative care. Hence, it is extremely important to ensure that only products of the highest quality are used,” MTaI Chairman & Director General Mr. Pavan Choudary said.
MTaI further said that the Association will work with its member companies to ensure compliance of the regulations. “MTaI and its member companies look forward to work with CDSCO to streamline the transition to the new requirements as and when the proposal is implemented,” Mr. Choudary added.
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.