A
Hi frnds
I could not get clear information on this from CDSCO or ICMR websites.
I want to mfg external (blood test) diagnostic kit and market in India.
What all regulation apply to this kit?
What are certification I need to get for mfg and mkt?
I heard that I don't need any certification from any body as it is not part of list of notified medical devices by CDSCO.
Yes it is not among the notified list of medical devices. and also is non critical diagnostic kit.
Do I need just shopping license and VAT registration for this?
When new regulations for medical devices are going to come?
Please enlighten me on this.
Regards
Alok
I could not get clear information on this from CDSCO or ICMR websites.
I want to mfg external (blood test) diagnostic kit and market in India.
What all regulation apply to this kit?
What are certification I need to get for mfg and mkt?
I heard that I don't need any certification from any body as it is not part of list of notified medical devices by CDSCO.
Yes it is not among the notified list of medical devices. and also is non critical diagnostic kit.
Do I need just shopping license and VAT registration for this?
When new regulations for medical devices are going to come?
Please enlighten me on this.
Regards
Alok
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