Public notice released for mandatory BIS quality approval fo
The Department of Pharmaceuticals (DoP) has issued 6 draft Quality control orders (QCOs), setting norms in accordance with the Bureau of Indian Standards (BIS) for medical devices to ensure safety and effectiveness.

A public notice comprising draft QCO's, prepared in consultation with BIS was released by Dept. of Pharmaceuticals, a part of Ministry of Chemicals & Fertilizers inviting comments/suggestions from all stakeholders latest by 15/04/2019.

As per the draft QCO, the devices shall conform to the corresponding standard specified and shall bear the standard mark under a license from the BIS.

BIS shall become the sole authority for certification and enforcement of medical devices once the draft comes into action. Medical devices intended for export shall not be covered under the QCO's.

The following medical devices are the part of public notice that shall be certified by BIS on approval of draft QCO:

- Cardiac defibrillators
- Infant radiant warmer
- Multifunction patient monitoring equipment
- Pulse Oximeter equipment
- Different types of Sphygmomanometers
- Clinical electrical Thermometers
- Blood glucose monitoring system for self-testing in managing Diabetes
- Surgical rubber gloves, Disposable surgical gloves, Single-use medical examination glove
- Surgical blades

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Read the complete Public notice by DoP here:
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