Starting October 1, 2023, ๐๐๐ ๐๐๐-๐๐๐๐๐๐๐๐ ๐ช๐๐๐๐ ๐ช ๐๐๐ ๐ช๐๐๐๐ ๐ซ ๐ด๐๐ ๐๐๐๐ ๐ ๐๐๐๐๐๐ shall be subject to the requirements of the ๐ด๐๐ ๐๐๐๐ ๐ซ๐๐๐๐๐ ๐น๐๐๐๐ 2017.
Since October 1, 2022, all non-notified Class A and Class B medical devices are subject to the ๐ด๐๐ ๐๐๐๐ ๐ซ๐๐๐๐๐ ๐น๐๐๐๐ 2017 and the manufacturers, whether local or foreign, are required to adhere to the rules for #importing/marketing their devices in #India.
The DCG(I)., while speaking at the 9th International Pharmaceutical exhibition (iPhex 2023) in Hyderabad, confirmed that the regulations are aimed at ensuring quality control and providing a facilitating environment.
As an emerging sector, medical devices manufacturing is on the rise, spurred by an upsurge in demand for many products during the pandemic and the governmentโs emphasis on ‘#makeinindia‘.
Earlier this year, the #cdsco had issued a circular setting the ๐ข๐ฐ๐๐ผ๐ฏ๐ฒ๐ฟ ๐ญ ๐ฑ๐ฒ๐ฎ๐ฑ๐น๐ถ๐ป๐ฒ ๐ณ๐ผ๐ฟ ๐๐น๐ฎ๐๐ ๐ ๐ฎ๐ป๐ฑ ๐๐น๐ฎ๐๐ ๐ ๐ป๐ผ๐ป-๐ป๐ผ๐๐ถ๐ณ๐ถ๐ฒ๐ฑ ๐บ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐ฑ๐ฒ๐๐ถ๐ฐ๐ฒ๐ to transition from the existing mandatory registration regime to a licensing regime.
It is suggested that the manufacturers/importers apply to the #cdsco with all the requisite documents for ๐ด๐ฟ๐ฎ๐ป๐ ๐ผ๐ณ ๐บ๐ฎ๐ป๐๐ณ๐ฎ๐ฐ๐๐๐ฟ๐ถ๐ป๐ด/๐ถ๐บ๐ฝ๐ผ๐ฟ๐ ๐น๐ถ๐ฐ๐ฒ๐ป๐๐ฒ at the earliest. Medical Devices that are not licensed after October 1, 2023, may not be allowed for Manufacturing/Import or sale in India.
For more information on the procedure to make the application and documents required for obtaining a manufacturing/import license, you can reach out to contact@8chealthcare.com.
