CDSCO Medical Devices FAQs 2024 Part-1 | Pharmadocx Consultants

[@hnirmal3891]

Sir, is cdsco license is required for the medical device components/machined parts which further process by finished product manufacturer. Please provide your insights on it. Thanks a lot

[@pharmadocxconsultants1345]

Yes Mfg License is needed

[@ShivamSharma-ve4dy]

Is test license under MD-13 mandatory (for Class B) before I get the manufacturing license? Also, one I get the MD-13, who will do the testing? Can I do it myself on human subjects or will it be done by a registered laboratory only?

[@pharmadocxconsultants1345]

You can do the testing yourself or can get tested by any other test laboratory who has license for it. You can not test on humans. Yashdeep Dahiya 9996859227 [e-mail] Pharmadocx Consultants, Opposite Dewan Mill, Old DC Road, Sonipat-131001

[@srinivasprasanna.v.c.6364]

Sir, a SW & HW developer (Contract design house) for medical devices need to register in CDSCO and get a license? If license need to be taken, should it be license or lone license to be obtained from the OEM

[@pharmadocxconsultants1345]

Both are possible sir

[@hnirmal3891]

Sir, suppose we have adequate QC data then whether we need to go for MD-12.But during manufacturing license test license needed.Then what justification to be provided in this case

[@pharmadocxconsultants1345]

MD-13 shall be obtained before you apply for Mfg License. Else your application can be rejected

[@ritikarashmi7485]

If my device is not mentioned in the medical device list then also MD 15 license will be applicable or only registration is required?

[@pharmadocxconsultants1345]

It depends on risk associated with your device. If it’s low risk then only registration else you will need import license

[@shivamkushwah3476]

Sir pharma company ko kholne key liye Mr ya or kisi department ka experience Lena chahiye batado sir

[@pharmadocxconsultants1345]

No sir anyone can open

[@AkashGupta-xb2si]

Sir you are having very simple way explained

[@pharmadocxconsultants1345]

Thanks sir

[@amandeepkarwasra7243]

Sir agar payment double ho gyi h to refund ho jayegi ??

[@pharmadocxconsultants1345]

There is no provision of refund

[@sanjaykoul7979]

Nice video. Is manufacturer licence required for class A device

[@pharmadocxconsultants1345]

If device is non measuring and non sterile then only registration is needed.

[@sanjaykoul7979]

@@pharmadocxconsultants1345 how to apply for registration

[@Divinebharat]

Sir MD42 KA LIC KAISEY CHK KAREY ONLINE

[@pharmadocxconsultants1345]

All states have not started issuing license online. If your license is issued online then you will find digital sign of issuing officer on it and then you can login the CDSCO portal with your user id and password to check the license.