Schedule D II Format for Medical Device Registration India

[SQ2012]

Hi,

Can anyone provide the Schedule D II format to be used for registration of a medical device in India. We have followed the guideline issued for medical devices in 2010, and used the Schedule DII formats as prescribed in this guideline. However we were told that since this guideline was never put into practice, we should be using the format as per the D&C Act.
The D&C Act doesn't have any schedule Schedule DII format for medical devices, it does have a separate DII for kits. are we supposed to use the DII format of Drugs for medical devices as well?? As many of the requirements as per this format would not be applicable for medical devices!

Please help.
Thanks

[Ajit Basrur]

In Reply to Parent Post by SQ2012

Hi,

Can anyone provide the Schedule D II format to be used for registration of a medical device in India. We have followed the guideline issued for medical devices in 2010, and used the Schedule DII formats as prescribed in this guideline. However we were told that since this guideline was never put into practice, we should be using the format as per the D&C Act.
The D&C Act doesn't have any schedule Schedule DII format for medical devices, it does have a separate DII for kits. are we supposed to use the DII format of Drugs for medical devices as well?? As many of the requirements as per this format would not be applicable for medical devices!

Please help.
Thanks

Are you looking for this document ? Refer pages 37 - 41 for Schedule D (II).

[SQ2012]

Thanks Ajit,
The Schedule D II format in this guidance is same as what is provided in the Drugs & Cosmetics Act. This guidance is for Drugs, however it seems CDSCO does not differentiatie the requirements for drugs and devices.

[Ajit Basrur]

In Reply to Parent Post by SQ2012

Thanks Ajit,
The Schedule D II format in this guidance is same as what is provided in the Drugs & Cosmetics Act. This guidance is for Drugs, however it seems CDSCO does not differentiatie the requirements for drugs and devices.

Yes, even the Schedule M 3 for Devices is not formalized yet.