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  #1  
Old 27th April 2012, 07:13 AM
SQ2012 SQ2012 is offline
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Please Help! Schedule D II Format for Medical Device Registration India

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

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Old 27th April 2012, 06:29 PM
Ajit Basrur's Avatar
Ajit Basrur Ajit Basrur is offline
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Re: Schedule D II Format for Medical Device Registration India

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In Reply to Parent Post by SQ2012 View Post

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).
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf CDSCO.pdf (762.4 KB, 22 views)

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  #3  
Old 28th April 2012, 12:56 AM
SQ2012 SQ2012 is offline
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Re: Schedule D II Format for Medical Device Registration India

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.
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Old 2nd May 2012, 04:21 PM
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Ajit Basrur Ajit Basrur is offline
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Re: Schedule D II Format for Medical Device Registration India

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In Reply to Parent Post by SQ2012 View Post

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.

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