Central Drugs Standard Control Organization (“CDSCO”) has clarified several queries with respect to grant of additional products and certificates like, Market standing certificate, Non-conviction certificate and performance certificate, etc. with respect to Medical Devices and In-vitro Diagnostics, under the Medical Devices Rules, 2017 (“Rules”).
Following are some of the clarifications issued by CDSCO:
- CDSCO has clarified that an applicant needs to submit an application form along with fees and documents in the new Medical Device Portal (https://cdscomdonline.gov.in/NewMedDev/Homepage) for obtaining a new licence, in the event of obtaining additional products for similar category of devices under existing licence.
- It has also been clarified by CDSCO that, as per the Rules, there is no requirement for compliance to Good Manufacturing Practices (“GMP”), but there is a need for compliance to Quality management Systems (“QMS”). As per the Rules, there is no requirement of GMP certificates for Medical Devices and In-vitro Diagnostics.
- CDSCO has further clarified that the Licensing Authority will issue the certificates such as Non-conviction certificate, validity certificate and market standing certificate.
Source : Central Drugs Standard Control Organization
