Medical devices in India are manufactured under the rules and regulations set by the regulatory authority of India, that is, CDSCO. In India, to manufacture a medical device, one should have a...

ISO 14385 Medical Devices Certification: Definition ISO 13485 Medical Devices certification, Medical Devices-quality management system (QMS) is an internationally agreed standard. It sets out the regulatory requirements for quality management systems specific...

India's central consumer protection body published rules for preventing misleading commercials and endorsements for misleading advertisements 2022 on June 9th, 2020. CCPA announced the Guidelines to fulfill the duties given to CCPA...

The new draft bill consists of a few new definitions such as clinical trials, over-the-counter drugs, manufacturers, cosmetics, medical devices, new drugs, bioavailability, investigational new drugs, imported spurious drugs, predicate devices and...

Class B Medical Devices / In-Vitro Diagnostic Kits Class B medical devices have low to moderate risk to the patients and public health risks. Class B medical devices’ permissions or approvals are...

Manufacturing And Product Development Support for Medical Devices / In-Vitro Diagnostic Kit The medical device industry of India is a crucial and integral part of the Indian healthcare industry. It provides preventative,...

The Ministry of Health and Family Welfare (Department of Health and Family Welfare) under the Government of India, on 18th January 2022, G.S.R.78 (E) released an official gazette with a few new...