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CDSCO has recommended PPE manufacturers in India to opt for ISO 13485 and / or ICMED 13485. Intertek is accredited and can provide these services.

Intertek
Intertek

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.

Union health ministry on February 11, 2020 had notified all medical equipment used on humans or animals as "drugs" under Section 3 of the Drugs and Cosmetics (D&C) Act, with effect from April 1, 2020 to ensure that all medical devices including PPE kits meet certain standards of quality and efficacy. “It is important all the manufacturers of PPE coverall are aware of the latest rules governing medical devices, enabling them to also take advantage of the provisions of voluntary registration with CDSCO,” as per the CDSCO advisory.
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medical device, india
Intertek
Intertek

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