Hi Ajit,
I was trying to share the information regarding validity medical device approvals in India here. The question is just to frame a subject line.
------------------------------
Sravan Kumar Manchikanti, RAC
Hyderabad
India
------------------------------
Original Message:
Sent: 26-Dec-2022 18:21
From: Ajit Basrur
Subject: What is the validity of the medical device license in India?
Sravan, could you clarify what your question is?
------------------------------
Ajit Basrur
Worcester MA
United States
Original Message:
Sent: 12-Dec-2022 09:17
From: Sravan Kumar Manchikanti, RAC
Subject: What is the validity of the medical device license in India?
The validity of the medical device license differs for different countries in the world. For some countries it is not time limited and for some countries it is for a specified duration (2/3/5 years). There are countries which need re-registration (redo the whole regulatory submission) after a specified period of time.
When it comes to ๐๐ฃ๐๐๐, #CDSCO has reformed the bureaucratic step of re-submission through the introduction of ๐ด๐๐
๐๐๐๐ ๐ซ๐๐๐๐๐ ๐น๐๐๐๐, ๐ฎ๐ฌ๐ญ๐ณ and made the validity of import/manufacturing license perpetual.
Only thing that manufacturers shall do is to pay the license retention fee every 5 years.
------------------------------
Sravan Kumar Manchikanti, RAC
Hyderabad
India
------------------------------