On 11th July 2022. in regard to the prior notification issued on 11th February 2020, “Notification No. G.S.R. 102 (E)”, the Central Drugs Standard Control Organisation, which is also known as CDSCO, has directed in India for all medical devices that fall under the category of Class A and Class B have to obtain Licensing mandatorily which is to come into effect from 1st October 2022. This is a Notification on Non-Notified Medical Devices where it is mandated for the Class and Class B Medical Products to apply for the issuance of a license under the CDSCO Licensing Authority in accordance with the Medical Devices Rules, 2017, which is also known as the MDR 2017.
What are the Non-Notified Medical Devices?
- The following devices mentioned below are the Non-Notified Medical Devices that are mandated to be registered by CDSCO –
- Anesthesiology Medical Devices
- Pain Management Medical Devices
- Cardiovascular Medical Devices
- Dental Medical Devices
- Ear, Nose, Throat Treatment Medical Devices, which is also referred to as ENT Treatment Medical Devices
- Gastroenterological Medical Devices
- Urological Medical Devices
- Operation Theatre Medical Devices, which is also referred to as OT Medical Devices
- Respiratory Medical Devices
- Neurology Medical Devices
- Personnel Use Medical Devices
- Obstetrical and Gynaecological Medical Devices, which is also referred to as OG Medical Devices
- Ophthalmology Medical Devices
- Rehabilitation Medical Devices
- Physical Support Medical Devices
- Interventional and Radiology Medical Devices
- Rheumatology Medical Devices
- Dermatology and Plastic Surgery Medical Devices
- Pediatric and Neonatology Medical Devices
- Oncology Medical Devices
- Radiotherapy Medical Devices
- Nephrology and Renal Care Medical Devices
- Software Medical Devices
Transition Period for Non-Notified Medical Devices
The CDSCO provided a “Transition Period” of Thirty Months for Class A and Class B Medical Devices to be counted from the date of implementation, where the Notification on Non-Notified Medical Devices stated that the producers are mandated to register their medical devices for licensing under CDSCO and to mandatorily label their granted CDSCO Registration Number in each medical Device.
For Medical Devices that fall under Class C and Class D are mandated to apply for licensing and are provided with the “Transition Period” of forty-two months to be counted from the date of the notification, i.e., 1st April 2020.
Compliance Measures for Non-Notified Medical Devices
To avoid confusion in regard to other entities providing Quality Assurance Certificates to Medical Devices that do not necessarily follow the compliance measures for each Regulation specified in Medical Devices Rules 2107, the CDSCO has declared for the License that is issued by their Regulatory Authority is deemed valid and no other Certificates or Licenses issued by any other entity is to act as a replacement of the CDSCO License. All producers of Medical Devices need to mandatorily comply with meeting the Requirements set by CDSCO for Licensing and have to be in accordance with the Medical Devices Rules, 2017.
Filling Procedure Measures for Non-Notified Medical Devices
The manufacturers of Class A and Class B medical devices are also required to apply for the CDSCO License under the applicable State Licensing Authority. Upon submission of the application and the necessary required documents, the CDSCO evaluates the documents and conducts Audits as per the requirement within the prescribed time in accordance with the Medical Devices Rules, 2017.
A particular Notification was issued on 25th April 2022 by the CDSCO, where it stated that to avoid any further delay, the CDSCO has advised the State Licensing Authorities to immediately issue Application Forms drafted in accordance with the Medical Devices Rules, 2017.
On 1st April 2020, the producers of Medical Devices were instructed to mandatorily submit the “Certificate of Compliance” in accordance with ISO 13485 Standards which are attributed by the National Accreditation Board for Certification Bodies or International Accreditation Forum for the Registration of the medical devices.
The CDSCO also specifies the Manufacturing License issued in accordance with the Medical Devices Rules, 2017 depicts that the Medical Device is in Conformance with the Fifth Schedule, i.e., Quality Management System of MDR, 2017 and the Separate GMP/QMS are prohibited from issuing any State Licencing Authority or Central Licensing Authority in accordance with the Medical Devices Rules, 2017.
For the purpose of maintaining of Quality of the Components and Raw Materials while being manufactured, it is mandated that specific components are required to be met for maintaining the standards of quality in accordance with the Quality Management System, ISO 13485. In case the products are being imported, the manufacturers need to also issue a “Free Sale Certificate” for the finished medical device product, which can be only imported into Global Harmonisation Task Force Countries, also known as GHTF Countries. The applicant is also mandated to submit the documentary evidence to the licensing authority for the grant of the license. The CDSCO is to then conduct an audit or inspection as deemed necessary.
Prior to the issuance of the said notification, only Notified Medical Devices were applicable for registering for CDSCO License. However, now all medical devices are required to comply with the registration process for CDSCO Licensing along with the thirty-seven Notified Medical Devices.