Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies with significant investments in India, on December 5 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 January 15. “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 post-operative care.

Hence, it is extremely important to ensure that only products of the highest quality are used,” MTaI Chairman & Director General 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.