Class C and Class D Medical Devices Regulatory Update, 2023.

Class C and Class D Medical Devices Regulatory Update, 2023.

The Central Drugs Standard Control Organisation (CDSCO) issued a circular on the 12th of April 2023 stating that Class C and Class D medical devices which are currently under mandatory registration will come under a licensing regime effective from 1st of October, 2023.

• The Central Drugs Standard Control Organisation (CDSCO) recently issued a circular stating that Class C and Class D (non-notified) medical devices which are currently under mandatory registration will transition into coming under a licensing regime (as per GSR 102(E) dated 11.02.2020), effective from the 1st of October, 2023.
• For obtaining the grant of manufacturing license for Class C and Class D medical devices, an inspection must take place within 60 days from the date of application by the Medical Devices Officers (MDO) of the Central Licensing Authority (CLA), as per the Medical Devices Rules (MDR) 2017.
• The Central Drugs Standard Control Organisation (CDSCO) recommends manufacturers and importers to apply for the grant of manufacturing/import license through their online portal, along with required documents and fees (Medical Devices Rules (MDR) 2017).

The applications will be processed proactively for issuing the licensure within the given time period so as to avoid disruptions in the supply chains of medical devices and access to patients.