Quality Council of India (QCI) launches Indian Certification of Medical Devices (ICMED) Plus Scheme further features to the ICMED Scheme that had been launched for Certification of Medical Devices in 2016. The ICMED 13485 PLUS, as the new scheme will undertake verification of the quality, safety and efficacy of medical devices. The ICMED 13485 PLUS Scheme was launched Virtually on 18th June 2021. ICMED 13485 Plus has been designed to integrate the Quality Management System components through witness testing of products with reference to the defined product standards and specifications. This is the first scheme around the world in which quality management systems along with product certification standards are integrated with regulatory requirements.
Indian Certification of Medical Devices (ICMED) Scheme
The Quality Council of India (QCI) launched the ICMED Scheme for Certification of Medical Devices in 2016.
Sources : PIB