Abbott has planned to train 60 Gujarat FDCA drug inspectors on medical device regulations following the notification of new medical device (MD) Rules which are effective from January 1, 2018 onwards. This is aimed at equipping notified officers to effectively implement new MD Rules 2017.

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.

The training is very much significant in the light of the fact that Gujarat today boasts of having the largest 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.

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

“Abbott which has been imparting hands-on-training to newly officers on auditing a medical device manufacturing facility will now offer training on new MD Rules. This is likely to start very soon this month,” informed Gujarat FDCA Commissioner Dr H G Koshia.

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.

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.  

US-based Underwriters Laboratories (UL), a global safety consulting and certification company had earlier trained 50 Gujarat MD inspectors to detect faulty medical devices.