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 in India, ICMED 13485.

Under ICMED Scheme, 3 Types of Certification:

  • ICMED 9000 which is based upon ISO 9001 plus additional requirements
  • ICMED 13485 based upon ISO 13485 plus additional requirements and
  • ICMED 13485 plus based upon ICMED 13485 plus Product specification as per ministry of health and family welfare technical specifications.

Who Can Apply for Certification?

  • Indian manufacturer or exporter
  • Indian medical device importer/distributor

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 (Initial certification audit in two stages (Stage 1 and Stage 2) & Recertification audits (before end of 3-year validity))
  • Granting of certification

Objective of Certification:

  • 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 Certification:

  • Build brand trust of medical devices manufactured in India
  • Enhance patient safety
  • Encouraging the Medium scale, small scale, startups companies to maintain their QMS up to an effective mark, by mentioning clear understanding the requirements for QMS
  • Designed in considering the Problems of Indian Medical Device Market
  • Importance given majorly to Health, Environment and safety Management system requirements.
  • Regulatory Requirements of India is covered under it.
  • ICMED 13485 forming base for the Product certification i.e. ICMED 13485 Plus in Indian Market.