In India, the manufacturing sites are used to determine whether to grant a manufacture or import licenses. In a nutshell, the licenses in India are site-specific. Prior to now, a change in the foreign manufacturer’s or its manufacturing facility’s address was regarded as a significant change and it necessitated the submission of a new import license application on the new address.
Because the address of the foreign manufacturer or its manufacturing site appears on the label, if the address changes and this is reflected on the label, the consignment cannot be shipped into India. The reason is that the new address on the label does not match the previous address on the import license.
However, thanks to the Medical Device Rules, 2017 and implementation of Post approval changes, which made path for submission of post approval change for change in address of foreign manufacturer or its manufacturing site.
You can now submit a post-approval change notification to the CDSCO if the foreign manufacturer’s address or manufacturing location changes. According to the Sixth Schedule of the Medical Device Rules of 2017, a change in a foreign manufacturer’s address or the location of its manufacturing is regarded as a significant change.
The list of documents required for submitting a post approval change notification for change in address of foreign manufacturer or its manufacturing site are as follows:
- Covering letter explaining the change
- Power Of Attorney
- Constitution details of the overseas manufacturer
- Old Import License
- Labels and IFU
- Undertaking from the manufacturer that there is no change in the PMF and DMF
- Manufacturing site or establishment or plant registration certificate from the country of origin
All the above-mentioned documents need to be submitted to CDSCO and upon review, the CDSCO will issue approval or rejection within a period of 60 days from the date of submission of the change notification.
If in case, no communication of approval or rejection is received from CDSCO within the period of 60 days, such change can be considered as approved only after which the importer can start importing the devices into India from the updated address.
Many inquiries about the impact of a foreign manufacturer’s or its manufacturing site’s change in location as well as how to notify CDSCO come to us. So, please feel free to get in touch with us @contact@8chealthcare.com if you are applying for an import license with CSDCO and intend to file a post approval change notification in the near future regarding changes to the address of the foreign manufacturer or its manufacturing facility.
