The Central Drugs Standard Control Organization (“CDSCO”) has issued Draft Classification of Non-Notified Medical Devices (“Draft Document”) on 3rd September 2020. CDSCO has invited comments of the concerned associations/ stakeholders till 3rd October 2020. The comments can be sent by email at: firstname.lastname@example.org.
Previously, the Ministry of Health and Family Welfare had issued notifications on 11th February 2020 (S.O. 648(E) and S.O. 102(E), wherein it had been stated that the medical devices which were covered under the definition, would be regulated in a phase-wise manner.
According to Rule 4(3) of the Medical Devices Rules, 2017 (which reads as: The Central Licencing Authority shall, classify medical devices referred to in rule 2, based on the intended use of the device and other parameters specified in the First Schedule), the Central Licensing Authority is required to classify the medical devices on the basis of risk-based approach.
In order to facilitate classification of all In-Vitro Diagnostic Medical Devices, they have been classified into 3 categories and have been examined basis classification followed internationally and also as per First Schedule of the Medical Devices Rules, 2017.