Indian Certification of Medical Devices (ICMED) Plus Scheme

Indian Certification of Medical Devices (ICMED) Plus Scheme

Subject : Governance

Context : Recently, the Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the ICMED.

Concept :

Indian Certification of Medical Devices (ICMED) Plus Scheme

• It had been launched for Certification of Medical Devices in 2016.
• It will undertake verification of the quality, safety and efficacy of medical devices.
• It has been designed to integrate the Quality Management System components and product related quality validation processes through witness testing of products.

The eligibility under ICMED scheme:

• Indian medical device manufactures/ exporters; and
• Local authorized representatives of medical device manufactures/ distributors

Importance of Indian Certification of Medical Devices (ICMED) Plus Scheme

• It is the first scheme around the world in which quality management systems along with product certification standards are integrated with regulatory requirements.
• It will be an end to end quality assurance scheme for the medical devices sector in India.
• It provides the much-needed institutional mechanism for assuring the product quality and safety.
• It will go a long way in assisting the procurement agencies to tackle the challenges relating to the menace of counterfeit products and fake certification.
• It will also help in eliminating the circulation and use of sub-standard medical products or devices of doubtful origin that could prove to be serious health hazards.