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Quality Control Orders (QCO)

What is a QCO?​

A Quality Control Order (QCO) is a mandatory certification requirement issued by the Ministry of Commerce and Industry (DPIIT) under the BIS Act 2016. QCOs require specified product categories to carry the BIS (Bureau of Indian Standards) certification mark (ISI mark) before they can be manufactured or imported into India.

Medical device QCOs​

The Indian government has issued QCOs for certain medical device categories as part of quality and safety improvement initiatives under Make in India. Affected categories have included:

  • Pulse oximeters;
  • Blood pressure monitors;
  • Specific categories of personal protective equipment.

New QCOs may be issued periodically. Manufacturers must check the BIS website and DPIIT notifications for QCOs affecting their product categories.

BIS certification process​

  1. Apply to BIS for product certification under the relevant Indian Standard (IS);
  2. Submit product samples for testing at a BIS-recognised laboratory;
  3. Undergo factory inspection by BIS;
  4. Receive BIS licence to apply the ISI mark.

Note: BIS QCO certification is in addition to (not a substitute for) the CDSCO import/manufacturing licence under MDR 2017.

Official source: Bureau of Indian Standards; DPIIT QCO notifications