Gujarat Food and Drug Administration (FDCA) is in talks with Abbott India to train drug inspectors on new Medical Device (MD) Rules which are effective from January 1, 2018 as part of its strategic partnership with the latter. This will immensely equip drug inspectors to effectively implement new medical device rules 2017.

Meanwhile, Abbott is also imparting hands-on-training to newly recruited drug inspectors on auditing a medical device manufacturing facility.

“Training on new MD Rules is likely to start from first week of May, 2018 based on the discussion with Abbott India,” informed Gujarat FDCA Commissioner Dr H G Koshia.

Gujarat today boasts of having the highest number of 200 plus licensed medical device units under Central Licensing Approval Authority (CLAA) scheme as against a total 284 medical device units in the entire country.

CLAA scheme was formed to oversee the regulatory activities related to grant of manufacturing license for hi- tech medical devices in India. It aims at ensuring that the medical devices being manufactured in India follow the standard requirements set by the government to ensure safety, efficacy and quality of the devices.  

The devices currently regulated under CLAA scheme include cardiac stents, drug eluting stents, catheters, intra ocular lenses, I.V. Cannula, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements.

Gujarat government had signed eight such strategic partnerships with overseas and Indian companies to upgrade the knowledge of the Gujarat FDCA officers on relevant areas of concern of the regulatory authorities globally and in India.

In order to detect faulty medical devices as per global standards, Gujarat FDCA did a similar kind of exercise of training 50 drug inspectors through a collaboration with US-based Underwriters Laboratories (UL), a global safety consulting and certification company.

MD Rules 2017 were notified last year and is into effect since January 1, 2018. Industry and legal experts however have raised some of the issues related to compliance to guidelines which have not been finalised as yet for its effective compliance.

One such issue is related to the guidelines on essential principles of safety and performance as stipulated in Rule 6 of MD Rules, 2017, which has not been notified as yet and hence the concern is that the companies might not have the time to comply with it as the rules have already come into effect. The subjects include post grant compliance, data protection, product recalls and product liabilities among others.  

New MD Rules 2017 sets new standards for requirement for manufacture of medical devices. Depending on the risk involved, medical devices have been classified into four classes i.e Class A, Class B, Class C and Class D.