Indian Certification of Medical Devices (ICMED) Plus Scheme

Context:

The Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the ICMED Scheme for Certification of Medical Devices.

About ICMED Plus Scheme:

• To fill the regulatory vacuum in quality certification space for medical devices in the country, the Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) is rolling out a voluntary quality certification scheme for medical devices.
• The Scheme is intended to enhance patient safety, and provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers.
• This move is also intended to significantly eliminate trading of sub-standard products or devices of doubtful origins, a widespread and injurious phenomenon in the Indian market.
• It was first launched in 2016.
• The ICMED 13485 PLUS Scheme was launched digitally.
• The program is based on the international harmonized quality management system standards with additional requirements specific to the India market.
  • ICMED 13485 – Based on the International Harmonized Standard (ISO 13485) “Quality Management Systems for Medical Devices” plus additional requirements specified under the scheme.
  • ICMED 9000 – Based on the International Harmonized Standard (ISO 9000:2008), “Quality Management Systems.”

Significance of scheme

Scheme will assist procurement agencies to tackle challenges related to counterfeit products and fake certification. It will also eliminate circulation and use of sub-standard medical products or devices of doubtful origin.

Quality Council of India (QCI)

• Quality Council of India is an autonomous body set up by the Ministry of Commerce and Industry, Government of India jointly with the

• Associated Chambers of Commerce and Industry of India (ASSOCHAM)
• Confederation of Indian Industry (CII)
• Federation of Indian Chambers of Commerce and Industry (FICCI)
• It aims to establish and operate national accreditation structure and promote quality through National Quality Campaign.
• Quality Council of India (QCI) is registered as a non-profit society with its own Memorandum of Association and is governed by a Council with equal representations of government, industry and consumers.
• Council plays a pivotal role at the national level in propagating, adoption and adherence to quality standards in all important spheres of activities

The Association of Indian Medical Device Industry (AIMED)

“AiMeD is an Umbrella Association of Indian Manufacturers of Medical Devices covering all types of Medical Devices including Consumables, Disposables, Equipments, Instruments, Electronics, Diagnostics and Implants.  With a Primary Membership of over 300 Manufacturers and additionally of over 200 Associate Members representing the interest of over 1200 Manufacturers of Medical Devices  to address the manufacturer’s problems.

The aim behind forming AiMeD is  allow the Indian Government to access a single point of contact and provide various services to the manufacturers like Advocacy on policy issues, Information services, Regulations for Medical Devices, Education and Training, services, Testing Assistance and guidance for Quality Certification (ISO, CE, GMP), Lobbying for funding for R&D from the Government, encourage innovations from member units, Improve clinician and patient access to the modern, innovative and reliable Medical Device technologies through organizing and supporting Meeting, Seminars, Symposia, Exhibitions and Demonstrations and also, to promote global harmonization and respect for the  Indian Device Industry.

IMDRRG – AiMeD has initiated the formation of the IMDRRG (Indian Medical Device Regulatory Review Group) it is an open informal forum – broad based consisting of Regulators, the Regulated Industry, the conformity assessment quality system auditing bodies like SGS/TUV/Intertek/UL/DNV/BSI, Testing Facilities and other Stake Holders – Consultants/Doctors/Nurses/Patients to review proposed regulations on ongoing basis and ensure that these are aligned to the GHTF (Global Harmonization Task Force) Guidelines – AI-MED wishes to collaborate with the Government. Currently we have over 300 individuals and organization representatives receiving e-mails with opportunity to use this forum for informal and candid e-mail exchange as well as pass on information to members of their organizations.

UdaiMeD – UdaiMed is a Forum of User – Developer – Academia – Industry – Medical Device Development interface with the Govt. It is a forum to make on-campus research more aligned to Medical Device Industry’s needs and catalyze ‘Make-in-India’ program. We have created this Forum for strengthening Industry-Institute Partnerships. This Forum will aim to address what kind of R&D or Product Development support do Indian Manufacturers need and what other Stakeholders seek from each other ?

Source: PIB