Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required?

mpfizer

Involved In Discussions
#1
We have MD 8 Lic. to manufacture Medical devices viz implants in INDIA , to sell the same is a whole sale lic. ie 20 21 B also required or can we do sales on the basis of our manufacturing lic.

Would appreciate help from anyone

Thanks

Michelle
 
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mpfizer

Involved In Discussions
#3
Thanks

so your view is that if we have a manufacturing lic. we do not need a separate whole sale lic. to sell the products we manufacture ...is my understanding correct?

i am referring to 20 21 B whole sale lic.
 

divyag

Starting to get Involved
#4
When you apply for manufacturing license in the online sugam portal, one of the checklist is wholesale license. So considering you have wholesale license for the facility, you can sell.

Irrespective of wholesale license, the priority is to have the manufacturing license which you have. The license states "Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device"
 

Regulatory

Involved In Discussions
#5
Hi Guys!!
We are preparing for CDSCO registration for our X-Ray based Diagnostic equipment according to Indian MDR 2017 but we have little bit confusion regarding equivalence with predicate devices because no any X-Ray based diagnostic medical device (i.e. C-ARM, CATHLAB, HF X-RAY, Mammography etc.) is registered with CDSCO to yet.
Please suggest how can we submit data to CDSCO with predicate devices as we are local manufacturer and available in market last 30+ years. Although our most of the products are CE marked..
Please also guide for that we have to apply with FORM MD-7 "Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device" or with any other Form for taking licence...

Looking forward for your guidance...

Thanks...
 

divyag

Starting to get Involved
#6
You can list the predicate device which is in the market even though it's not registered with CDSCO, and provide a justification for the same. or apply MD25 which will lead for new device consideration.
You need to submit the DMF, PMF, test reports and essential requirement, clinical validation, post marketing plan, Risk management along with CE certificate and NB audit report. If the device is USFDA cleared then most of the sections can be waived off.

MD-7 for mfg license is applicable and as per your statement no predicate device, apply MD25 (permission to mfg device which does not have predicate device)
 

Regulatory

Involved In Discussions
#7
You can list the predicate device which is in the market even though it's not registered with CDSCO, and provide a justification for the same. or apply MD25 which will lead for new device consideration.
You need to submit the DMF, PMF, test reports and essential requirement, clinical validation, post marketing plan, Risk management along with CE certificate and NB audit report. If the device is USFDA cleared then most of the sections can be waived off.

MD-7 for mfg license is applicable and as per your statement no predicate device, apply MD25 (permission to mfg device which does not have predicate device)
Thanks for the guidance..
Our devices are not new for market and already available in Indian and export market. In that case providing justification, that devices are available in market since a long time and are safe and reliable according to PMS feedback along with list of available devices in market of other manufacturers would be sufficient to apply with form MD7 or need any other data instead of DMF, PMF, Test reports etc..
If we go with the Form MD26 (permission to mfg device which does not have predicate device) then we have to do the clinical investigation separately and also submit the data according to Part IV (Information required to be submitted with the Application Form for import or manufacture of medical devices which does not have predicate device.) along with DMF, PMF, test reports etc..
Please guide...

Thanks...
 
#10
Thanks

so your view is that if we have a manufacturing lic. we do not need a separate whole sale lic. to sell the products we manufacture ...is my understanding correct?

i am referring to 20 21 B whole sale lic.
Yes, you can sell only those products which you manufacture. The list of the devices which are includes in prior approval or in Free Sale Certificate.
 
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