With the launch of Medical Product Regulations since 2017, all medical products falling under
CLASS 1, CLASS2 and CLASS 3 shall have to undergo certification to Quality Council of India QCI accredited ICMED Indian Certification for Medical devices.
The legal requirements will be in force w.e.f 2018 and shall comply to all the specifications and requirements for factories manufacturing, trading or supplying medical products falling under CLASS 1, CLASS 2 or CLASS 3 type.
QCI has launched ICMED in 3 categories for certification
- ICMED 9000 – based upon ISO 9001 plus additional requirements
- ICMED 13485 — based upon ISO 13485 plus additional requirements
- ICMED 13485 Plus – based upon ICMED 13485 pluS Product specifications prescribed by MoH
All organisations supplying, trading or manufacturing have to mandatorily achieve certification by QCI accredited Notified body.
GQS was one of the first to attend major seminars on this subject and has been in the field of Medical product certification since 2001 and registered by QCI since its inception.