COVID-19 has increased the need for masks and other PPEs to protect ourselves from the pandemic. This in turn created a demand in the production/manufacturing of PPE’s. In India, CDSCO the regulatory body for medical device manufacturers, has recommended that the manufacturers be ISO 13485 certified.
As an alternative to ISO 13485, India also has a bespoke accreditation for medical device manufacturers, ICMED 13485, and ICMED 9000, which were developed by the local Accreditation Body NABCB.
Intertek is accredited by NABCB to provide certification services to the ICMED 9000, ICMED 13485, and ISO 13485 standards.