Regulation of medical devices and their quality systems in India was limited compared with other developed nations that typically have very robust approval systems for medical devices in place. Together with the Quality Council of India (QCI) and the N
Regulation of medical devices and their quality systems in India was limited compared with other developed nations that typically have very robust approval systems for medical devices in place.
Together with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB), the Association of Indian Medical Device Industry (AIMED) has developed a voluntary quality certification scheme for medical devices in India, Indian Certification for Medical Devices (ICMED)
It is the country's first indigenously developed quality assurance system mandatory for all medical devices marketed in the nation. This was proposed in a recent meeting called for the drafting of (separate) rules for medical devices with government officials with a special focus on drafting regulatory framework for the granting of medical device manufacturing licenses.
The meeting discussed how to proceed with the registration of manufacturers and importers of medical devices on an online GoI portal. Most importantly, the meeting stressed the need for the registration of low-risk and moderate-risk devices based on certification by 3rd Party (CAB) and the granting of a manufacturing license to manufacturers and importers of high-risk devices based on specified criteria. This will be achieved by CDSCO medical devices officers with a predefined competency or by certification bodies of 3rd party according to sources.
➲ It is aimed at enhancing patient safety and provides enhanced customer protection.
➲ The scheme is intended to significantly eliminate the trading of sub-standard products or devices.
➲ Most significantly, it will reduce considerable time and costs for Indian companies to receive internationally recognized quality certification,
Benefits of registration
➲ Build brand trust of medical devices manufactured in India
➲ Enhance patient safety
➲ Provide healthcare users with quality medical devices manufactured in a certified facility
Who can apply for certification?
➲ Indian manufacturer or exporter
➲ Indian medical device importer/distributor
ICMED certification is of two types:
➲ ICMED 9000 (an ISO 9001plus additional requirement)
This certification is for low-risk medical devices
➲ ICMED 13485 (an ISO 13485 plus additional requirement)
This certification is for medium or high-risk devices.
Procedure for certification:
➲ File application form along with required document and fees
➲ The certifying body will raise a query if any within 7 working days from the receipt of application
➲ The applicant will respond to that raised query in the prescribed format
➲ Audit program
For ICMED 9000 & ICMED 13485 the audit cycle shall include:
➲ Granting of certification
Documents required for citification:
➲ Organization registration certificate
➲ Organization detail (Manufacturing/importer)
➲ Organization authorized signatory detail (ID and Address proof)
➲ Medical equipment detail
➲ Holding ISO certificate
➲ Importing company detail and exporting company detail (in case of import)
Regulation of medical devices and their quality systems in India was limited compared with other developed nations that typically have very robust approval systems for medical devices in place. Together with the Quality Council of India (QCI) and the NRead More
One of the world's leading food protection and quality control programs, the SQF (Safe Quality Food) program which is developed to meet the needs of retailers and suppliers around the world. SQF offers independent certification that a product, process,Read More
Food safety is a regular concern not only for consumers but for every food industry stakeholder as well. Feed safety is equally important for animal products, especially in the light of the various food scandals that have occurred in the past years. The ERead More
The National Health Authorities grant this CoPP certificate upon request from the consumer, the authorities, or the drug supplier in the importing country. This certificate refers to a particular product whether or not it is sold in the country of originRead More
Hallmarking is a way of preserving the buyers' interest. BIS Hallmark is a device that lets you assess the pureness of the country's gold and silver gems. It is a certification issued by India's national quality organization Bureau of Indian Standards (BIRead More
DRDO is the Ministry of Defense's R&D department, Govt of India, with a vision to empower India with state-of-the-art weapons systems and a mission to achieve self-reliance on critical defense technology and systems, while equipping our armed forces withRead More
BIS is a national body that ensures the quality, safety, and reliability of Indian goods. BIS is intended to analyze product samples while they are in the preliminary and surveillance stages. India has 8 centre, 4 regional, and 3 BIS branch laboratories iRead More
Good Manufacturing Practice (GMP) Is a manufacturing and testing process which helps to ensure a product of quality. GMP guidelines are not prescriptive instructions for how to manufacture goods. There are a set of general concepts that have to be followeRead More
The National Organic Program (NOP) is a federal legislative system for organic food in the United States of America. It is also named after the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) system responsible for theRead More
TEC stands for Telecommunication Engineering Center. TEC facilitates the development and enforcement of various standards and policies by the Department of Telecommunications, Government of India, for the safe and efficient use of emerging telecommunicatiRead More
The Agricultural & Processed Food Products Export Development Authority (APEDA) is a government agency founded in 1985 to develop and facilitate the export of scheduled goods. It offers financial support, information and advice on the production of scheduRead More
SITRA stand for South India Textile Research Association, established in 1956 is governed by a council administration consisting of member representative of the industry, government and scientists. It sponsored by ministry of textile of government of IndiRead More
The WPC (Wireless Planning & Coordination) is a division of communications and information technology ministry, telecommunications department, India. Wireless Planning & Coordination involves the planning, managing, and monitoring of radiofrequency and geRead More
DGFT Approval for Import of Restricted Items is mandatory to import any restricted item in India prescribed by the DGFT in the Foreign Trade (Development and Regulation) Act of 1992 and Indian Export Import (EXIM) Policy. The import and export of all gRead More
Uniquely repurpose strategic core competencies with progressive content. Assertively transition ethical imperatives and collaborative manufactured products.Write About Us