CURRENT AFFAIRS

Detailed explanation-1: -The Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) in collaboration with the Association of Indian Medical Device Industry (AIMED) have rolled out a voluntary quality certification scheme for medical device industry in the country.

Detailed explanation-2: -Medical devices and IVDs are regulated by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and Family Welfare.

Detailed explanation-3: -Notes: ICMED is the name of the scheme that was launched for Certification of Medical Devices in the year 2016. Recently, the Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added some features to the scheme. The new scheme is renamed as ICMED 13485 PLUS.

Detailed explanation-4: -ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose.