In order to implement the new Medical Device (MD) Rules, the Gujarat Food and Drug Control Administration (FDCA) has notified 145 MD officers to inspect Class A and Class B medical device manufacturing units in the state and another 30 district level officers as licensing authorities for registration and grant of licenses.
The state regulator had in the past sent draft notifications to the state government to designate notified officers to regulate medical device units under the current regulatory framework.
Depending on the risk involved, central licensing authority has classified the medical devices into four classes i.e Class A, Class B, Class C and Class D. In vitro diagnostic medical devices have been classified on the basis of parameters specified in Part I of the First Schedule, in the following classes, namely low risk - Class A; low moderate risk-Class B; moderate high risk-Class C; high risk-Class D.
Meanwhile, the state regulator has started the process of forwarding applications of manufacturers under category B medical devices to seek inspection reports from the notified bodies recently appointed by the Central Drugs Standard Control Organisation (CDSCO).
State licensing authority has to send applications to the notified bodies for inspections and auditing of Class A and Class B category medical devices for compliance. Class C and Class D category are audited by the central licensing authority as per rules.
Intertek India Pvt Ltd and TUV Rheinland India Pvt Ltd are the notified bodies registered with the CDSCO to carry out auditing of manufacturing sites as per the provisions of new MD Rules.
As per the new MD Rules, there is a need for a plan and to develop a consistent processes needed for product realization and also requirements for risk management (as per ISO 14971) throughout product realisation. There is also a mandate to implement effective arrangements for communicating with customers with reference to product information, customer feedback, advisory notices and maintenance of a record for each batch of device that provides traceability and identifies the amount manufactured and approved for distribution after verification.
As per Rule 20, there would be no requirement for audit of the manufacturing site prior to grant of license for Class A medical device and that there is a requirement for audit of manufacturing site by registered notified body before grant of license for class B medical device. Rule 21 stipulates guidelines for manufacturing of Class C or Class D medical device and its application of grant of license or loan license to central licensing authority (CLA). As per the rules, CLA may, where required, avail the services of notified body for inspection.
For sound understanding and effective implementation of new MD rules, the state regulator recently concluded workshops with US based medical technology major Abbott to sensitise inspectors.
New MD Rules 2017 effective from January 1, 2018 sets new standards for manufacturing and use of medical devices. As per the new rules, manufacturers are expected to adhere to stringent quality management system, while carrying out manufacturing of medical devices. It covers medical devices and in vitro diagnostics, disinfectants, surgical sutures, ligature, condoms, bandages, etc.
Gujarat has the maximum number of 250 licensed medical devices units which include both low risk and high risk devices.