The Central Standards Control Organisation (CDSCO) on July 12, 2022 has issued a clarification on obtaining of manufacturing license for Class A and Class B medical devices after noticing that some other entities are issuing quality certificates to the manufacturers at their own level, which is becoming a source of confusion for manufacturers vis-a-vis the prescribed regulatory pathway for obtaining the licensure for such medical devices under Medical Devices Rules (MDR), 2017.
CDSCO 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 recognize any such certificates which are not mentioned in it or part of it.
CDSCO also advised that all manufacturers shall apply for obtaining manufacturing license for Class A & 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 the case may be) as per stipulated time specified in MDR, 2017 in order to avoid further delay.
[File No. 29/Misc./03/2022-DC-94]
