05 December 2018 | News
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 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.
Medical Technology Association of India (MTaI) has 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.
Pavan Choudary, Chairman & Director General, MTaI said, “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 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,” he added.
MTaI further said that the Association will work with its member companies to ensure compliance of the regulations.