New Delhi : With all non-notified medical devices of Class A and Class B categories scheduled to enter licensing regime with effect from October 1, 2022, the drug regulator has said that the quality certificates issued by other entities shall not be a replacement of license to be granted by the competent licensing authority.
The Central Drugs Standard Control Organisation’s (CDSCO) clarification comes after the regulator noticed that some other entities are issuing quality certificates to the manufacturers at their own level, which is becoming a source of confusion for manufacturers as against the prescribed regulatory pathway for obtaining the licensure for such medical devices under the Medical Devices Rules (MDR), 2017.
“In this regard, it is hereby clarified that such quality certificates issued by other entities shall not be a replacement of licensure to be granted under MDR, 2017 by the competent Licensing Authority. All manufacturers shall have to comply with the licensing requirement and obtain the license as per MDR, 2017, as the said rules do not recognise any such certificates which are not mentioned in it or part of it,” said Dr. V G Somani, Drugs Controller General (India).
The manufacturers shall apply for obtaining manufacturing license for Class A and Class B medical devices through CDSCO’s on-line portal so that the manufacturing license can be granted by respective State Licensing Authorities after review of the applications and audit as per stipulated time specified in MDR, 2017 in order to avoid further delay.
The CDSCO has already taken up the issue of timely licensing process through a notice on April 25, 2022, requesting all State Licensing Authorities to dispose of the applications received by them as per MDR, 2017 in time to avoid the disruption of the supply of such devices to the patients.
A notification in April 1, 2020, directed the manufacturers and importers to upload a certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of the medical devices as part of the registration process.
CDSCO has earlier clarified that the existence of manufacturing license under Medical Device Rules 2017 indicate conformance of fifth schedule (Quality Management System) of MDR-2017 & Separate GMP/QMS are not prescribed for issuance by CLA/SLA under Medical Device Rules- 2017.
With respect to quality of components/raw materials to be used for further manufacturing of finished medical devices under the valid licence for manufacturing, it is required that these components need to qualifying quality standards and Quality Management System (ISO 13485) and, if imported, need to have Free Sale Certificate of their finished product in the GHTF countries. The documentary evidence of the same shall be submitted to the licensing authority (who is issuing manufacturing licence) at the time of grant of licence & subsequently, as & when required. Further, it shall also be available for audit/inspection, whenever required, says the CDSCO.
The regulator has been providing a transition period of 30 months for Class A and B medical devices, which are for low risk and low moderate risk respectively, from the date of implementation of the notification on April 1, 2020, for the transition to licensing regime. During the period, the manufacturers were required to register their products on the CDSCO portal established for the purpose by the regulator and to affix the registration number on the label of such registered medical devices.
The medical devices which are of moderate high risk (Class C) and high risk (Class D) are scheduled to complete transition to licensing regime in 42 months from the date of notification on April 1, 2020.Notice_220711_231050-130722080920