Figure 1: Medical device categories newly subjected to QCOs
Recently, six draft Quality Control Orders (QCOs) have been proposed in India for six main notified medical device categories, namely medical electrical (active) equipment, blood pressure measuring units (sphygmomanometer), digital thermometers, blood glucose monitoring system, examination/surgical gloves and surgical blades.
After consulting with the Bureau of Indian Standards (BIS), the Department of Pharmaceuticals of India’s Ministry of Chemicals and Fertilizers had issued the following QCOs to ensure safety and effectiveness of these medical devices:
- Medical Electrical Equipment (Quality Control) Order, 2018
- Sphygmomanometers (Quality Control) Order, 2018
- Clinical Electrical Thermometers (Quality Control) Order, 2018
- Blood Glucose Monitoring System (Quality Control) Order, 2018
- Gloves (Quality Control) Order, 2018
- Surgical Blades (Quality Control) Order, 2018
These QCOs are now open for stakeholders' feedback till 15th April 2019. All six of these QCOs propose the following:
- Compulsory use of Standard Mark for Goods or articles specified in the QCOs shall conform to the corresponding Indian Standard given therein and shall bear the Standard Mark under a license from the BIS Regulations, 2018. The draft QCOs also suggest that nothing in these Orders shall apply in relation to goods or articles meant for export, which conform to any specification required by the foreign buyer.
- The BIS shall be the certifying and enforcing authority for the goods/articles specified in QCOs. In addition, an officer not below the rank of General Manager, Distinct Industries Center in Department of Industries of the State Government shall also be the enforcing authority.
- Any person who contravenes the provisions of this Order shall be punishable under the provisions of the BIS Act. The latest version of Indian Standards including the amendments issued thereof, as published and notified by the Bureau from time to time, shall be applicable from the date as notified by the Bureau.
The draft orders once finalized will make BIS the certifying and enforcing authority for these medical devices. As for other medical devices, which are currently not being notified to be able to closely monitor or regulate yet, plans to include them in the list of notified medical devices are currently ongoing.
Draft Quality Control Orders (QCOs) proposed by the DoP