The Drugs Controller General of India (DCGI) has announced that manufacturers and importers of high-risk medical devices who have applied for a license before September 30 can continue to supply them in the market for another six months. New regulations state that medical devices in the class C and class D categories cannot be sold without a license. Many manufacturers have applied for licenses but have not received them on time. The government s think tank, NITI Aayog, has recommended that all medical devices meet safety and quality standards.
The Central Drugs Standard Control Organisation (CDSCO) had set the October 1 deadline for bringing ‘class C and ‘class D medical devices under regulation as part of quality control efforts. To obtain the licences several manufacturers had submitted applications, but the government failed to provide them on time.
Earlier this year, the Central Drugs Standard Organisation (CDSCO) had set the October 1 deadline for bringing class C and class D medical devices under regulation to control quality. According to the new regulation, medical devices belonging to these categories, such as ventilators, imagining equipment, oxygen therapy equipment, nebulisers, x-ray equipment, surgical robots and oncology treatment linear accelerator, can t be sold from October 1 without a manufacturing licence.
The National Medical Devices Policy should benefit the ultimate consumer in terms of lower prices by capping the maximum retail prices (MRP) of the devices, a top official of the Association of Indian Medical Devices Industry (AiMeD) said on .
Chennai, May 4: The National Medical Devices Policy should benefit the ultimate consumer in terms of lower prices by capping the maximum retail prices (MRP) of the devices, a top official of the Association of Indian Medical Devices Industry (AiMeD) said on Thursday.