About new CDSCO notification
CDSCO (Central Drugs standard control organization) regulatory body, responsible for the regulations of medical devices in India, issued guidelines for the mandatory registration of Class A and Class B medical devices. The previous guideline clearly states that manufacturers or importers need to mandatory register their medical device within the given time-frame to avoid suspension activity against manufacturers. With reference to this CDSCO has recently issued a notification about obtaining a valid license for manufacturing medical devices.
All non-notified medical devices of Class A and class B will be under licensing regime with effect from October 1,2022. A transition period of 30 months, i.e. from April 1,2020 to October 1,2022, had been provided for Class A and Class B medical devices. During this transition period manufacturers need to register their devices with CDSCO portal, so that they can affix the registration number on the label of such registered medical devices.
The recent notice from CDSCO is about issuing the quality certificate to manufacturer.
It’s been observed that few entities are issuing certificates to manufacturers at their level which creates ambiguity among the manufacturers. CDSCO clearly mentioned in their notice that, “the certificate issued by the other entities will not be a replacement of a licensure granted under MDR 2017. All manufacturers need to obtain a CDSCO manufacturing license as per MDR2017.
It is advisable for the manufacturers to apply to CDSCO portal for manufacturing license for Class A and Class B medical devices. The manufacturing license will be granted by the State License Authority (SLA) after reviewing the documents and performing the audit if needed. All State License Authorities are requested to dispose of the applications in time received by them to avoid disruption of supply of devices to the patients.
In a nutshell, there are a few things to remember:
- The medical device manufacturer or importer needs to obtain a CDSCO license.
- The CDSCO license will be granted by SLA after reviewing the documents.
- Most important fact is the certificate issued by the entities will not be a replaced with the licensure granted under MDR 2017.
The updated rules and regulations are issued for the safety of patients, but not every manufacturer can understand it clearly. Many times, these notices or regulations create confusion and the device makers miss the timelines. To avoid this, we have launched a regulatory Newsletter, which will keep you updated. To read more regulatory news kindly subscribe to our newsletter!
