Medical Devices classification as per FDA | Medical Device Regulations |

Devices are classified into one of three regulatory classes: class I, class II, or class III. Watch the video for more details and share it with all your friends on social media.
โฑ๏ธ ๐‘ป๐’Š๐’Ž๐’† ๐‘บ๐’•๐’‚๐’Ž๐’‘ โฑ๏ธ
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0:00 - Introduction
๐Ÿ“– ๐๐ž๐ฌ๐ญ ๐๐จ๐จ๐ค ๐จ๐ง ๐€๐ฆ๐š๐ณ๐จ๐ง ( ๐ŸŽญ ๐Œ๐ฎ๐ฌ๐ญ ๐‘๐ž๐š๐ )
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๐Ÿšฉ ๐–๐จ๐ซ๐ฅ๐โ€™๐ฌ ๐†๐ซ๐ž๐š๐ญ๐ž๐ฌ๐ญ ๐๐จ๐จ๐ค๐ฌ ๐…๐จ๐ซ ๐๐ž๐ซ๐ฌ๐จ๐ง๐š๐ฅ ๐†๐ซ๐จ๐ฐ๐ญ๐ก & ๐–๐ž๐š๐ฅ๐ญ๐ก
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๐Ÿšฉ ๐‹๐ž๐š๐ง ๐๐ซ๐จ๐๐ฎ๐œ๐ญ๐ข๐จ๐ง ๐’๐ข๐ฆ๐ฉ๐ฅ๐ข๐Ÿ๐ข๐ž๐: ๐–๐จ๐ซ๐ฅ๐'๐ฌ ๐Œ๐จ๐ฌ๐ญ ๐๐จ๐ฐ๐ž๐ซ๐Ÿ๐ฎ๐ฅ ๐๐ซ๐จ๐๐ฎ๐œ๐ญ๐ข๐จ๐ง ๐’๐ฒ๐ฌ๐ญ๐ž๐ฆ
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๐Ÿ“ข๐Ÿ“ข ๐Ÿ“ข๐Ÿ“ข ๐…๐จ๐ฅ๐ฅ๐จ๐ฐ๐ฌ ๐ฎ๐ฌ ๐จ๐ง ๐‘บ๐’๐’„๐’Š๐’‚๐’ ๐‘ด๐’†๐’…๐’Š๐’‚
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๐Ÿฆ๐“๐ฐ๐ข๐ญ๐ญ๐ž๐ซ : / digitalelearni1
๐Ÿ“ธ ๐ˆ๐ง๐ฌ๐ญ๐š๐ ๐ซ๐š๐ฆ : / digital_elearning
๐Ÿ“ฉ ๐“๐ž๐ฅ๐ž๐ ๐ซ๐š๐ฆ : t.me/digital_e_learning007
๐Ÿ™‹๐Ÿปโ€โ™‚๏ธ ๐๐ข๐ง๐ญ๐ซ๐ž๐ฌ๐ญ: / digitalelearning007
๐Ÿ™‹๐Ÿปโ€โ™‚๏ธ ๐‹๐ข๐ง๐ค๐ž๐๐ˆ๐ง ๐๐š๐ ๐ž: / 55180987
๐Ÿ™‹๐Ÿปโ€โ™‚๏ธ ๐…๐š๐œ๐ž๐›๐จ๐จ๐ค ๐๐š๐ ๐ž : / digitalelearni1
๐Ÿ’Œ ๐‘ช๐’๐’๐’•๐’‚๐’„๐’• ๐’–๐’” : digital.e.learning007@gmail.com for any business/ promotion queries.
โœ๏ธ ๐““๐“ฒ๐“ผ๐“ฌ๐“ต๐“ช๐“ฒ๐“ถ๐“ฎ๐“ป:
Copyright Disclaimer under section 107 of the Copyright Act of 1976, allowance is made for โ€œfair useโ€ for purposes such as criticism, comment, news reporting, teaching, scholarship, education and research. Fair use is a use permitted by copyright statute that might otherwise be infringing. The information contained in this video is just for educational and informational purposes only and does not have any intention to mislead or violate Google and KZread community guidelines or policy. I respect and follow all terms & conditions of Google & KZread.
๐‚๐จ๐ฆ๐ฆ๐จ๐ง ๐Š๐ž๐ฒ ๐ฌ๐ž๐š๐ซ๐œ๐ก ๐ซ๐ž๐ฅ๐š๐ญ๐ž๐ ๐ญ๐จ ๐ญ๐ก๐ข๐ฌ ๐ญ๐จ๐ฉ๐ข๐œ :
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ะŸั–ะบั–ั€ะปะตั€: 73

  • @DigitalELearning
    @DigitalELearning5 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    ๐Ÿ‘€ Hello Friends, ๐‰๐จ๐ข๐ง my ๐‘บ๐’๐’„๐’Š๐’‚๐’ ๐‘ด๐’†๐’…๐’Š๐’‚ ๐‘ณ๐’Š๐’๐’Œ for regular updates: ------------------------------------------------------------------------------------------------------------------ ๐Ÿ“ธ๐ˆ๐ง๐ฌ๐ญ๐š๐ ๐ซ๐š๐ฆ : instagram.com/digital_elearning/ ๐Ÿฆ๐“๐ฐ๐ข๐ญ๐ญ๐ž๐ซ: twitter.com/DigitalELEARNI1 ๐Ÿ“ข๐“๐ž๐ฅ๐ž๐ ๐ซ๐š๐ฆ : t.me/digital_e_learning007 ๐Ÿ™‹๐Ÿปโ€โ™‚๐–๐ก๐š๐ญ๐ฌ๐€๐ฉ๐ฉ (๐‹๐ž๐š๐ง ๐ฌ๐ข๐ฑ ๐ฌ๐ข๐ ๐ฆ๐š) : whatsapp.com/channel/0029VaAUuqs4inooet3e4S3O ๐Ÿ™‹๐Ÿปโ€โ™‚๐–๐ก๐š๐ญ๐ฌ๐€๐ฉ๐ฉ (๐’๐ข๐ฑ ๐’๐ข๐ ๐ฆ๐š (๐Ÿ”ฯƒ ) : whatsapp.com/channel/0029VaEWKWbIiRovZpAduc0p ๐Ÿ™‹๐Ÿปโ€โ™‚๐–๐ก๐š๐ญ๐ฌ๐€๐ฉ๐ฉ (๐’๐ญ๐š๐ญ๐ข๐ฌ๐ญ๐ข๐œ๐ฌ & ๐‘๐ž๐ฌ๐ž๐š๐ซ๐œ๐ก) :whatsapp.com/channel/0029VaAGwzTDJ6H9S5Q4Ow0m ๐Ÿ™‹๐Ÿปโ€โ™‚๐–๐ก๐š๐ญ๐ฌ๐€๐ฉ๐ฉ (๐๐ซ๐จ๐ฃ๐ž๐œ๐ญ ๐Œ๐š๐ง๐š๐ ๐ž๐ฆ๐ž๐ง๐ญ) :whatsapp.com/channel/0029Va8slQdEAKWAhXoQK13B ๐Ÿ™‹๐Ÿปโ€โ™‚๐–๐ก๐š๐ญ๐ฌ๐€๐ฉ๐ฉ (๐๐ฎ๐š๐ฅ๐ข๐ญ๐ฒ ๐€๐ฌ๐ฌ๐ฎ๐ซ๐š๐ง๐œ๐ž & ๐๐ฎ๐š๐ฅ๐ข๐ญ๐ฒ ๐‚๐จ๐ง๐ญ๐ซ๐จ๐ฅ) :whatsapp.com/channel/0029VaAKJBGKGGGDjcK4mw2h

  • @vivaanbo3905

    @vivaanbo3905

    2 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    I know it's kinda randomly asking but does anyone know of a good website to watch new tv shows online ?

  • @kelvinspencer6971

    @kelvinspencer6971

    2 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    @Vivaan Bo Flixportal :)

  • @vivaanbo3905

    @vivaanbo3905

    2 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    @Kelvin Spencer Thank you, I signed up and it seems to work =) Appreciate it !!

  • @kelvinspencer6971

    @kelvinspencer6971

    2 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    @Vivaan Bo happy to help :D

  • @rohan5753
    @rohan5753ะะน ะฑาฑั€ั‹ะฝ

    nice informative video

  • @DigitalELearning

    @DigitalELearning

    ะะน ะฑาฑั€ั‹ะฝ

    Thanks ๐Ÿ‘

  • @fazil264
    @fazil2643 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    if you could remove the background music, would be wonderful. Thank you!

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Fazil thanks for your input. Unfortunately I cannot remove but yes going forward I will not add this music

  • @fazil264

    @fazil264

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    @@DigitalELearning This was so informative. Thanks for acknowledging.

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Thanks for supporting

  • @rajatkohli7141
    @rajatkohli71414 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Nice content beautifully explained . Understood all. Thank you for sharing this

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Thanks for watching.. ๐Ÿ˜€๐Ÿ“บ

  • @TheShubhamdel06
    @TheShubhamdel062 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Very nicely explained in a short time. Got some basic info. Thank you so much

  • @DigitalELearning

    @DigitalELearning

    2 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Glad it was helpful! Thanks ๐Ÿ˜Ž

  • @shilpatil29
    @shilpatil292 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Very nice explanation for beginners, thanks for sharing ๐Ÿ‘

  • @DigitalELearning

    @DigitalELearning

    2 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Glad you liked it

  • @dayabachala2859
    @dayabachala2859 ะ–ั‹ะป ะฑาฑั€ั‹ะฝ

    Hi, Thank you for the Info. Could you please share any sample PMS Plans or PMSR templates done as per 21CFR?

  • @sumantiwari4985
    @sumantiwari49856 ะฐะน ะฑาฑั€ั‹ะฝ

    Thanks a lot ๐Ÿ™๐Ÿป

  • @DigitalELearning

    @DigitalELearning

    6 ะฐะน ะฑาฑั€ั‹ะฝ

    You're welcome ๐Ÿ˜Š

  • @gorakhghuge6522
    @gorakhghuge65223 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Very nice information. Thank you..

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Thanks Gorakh

  • @lopeztaylor994
    @lopeztaylor9945 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Great job.

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Thanks

  • @anoopbaghel7866
    @anoopbaghel78663 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Whether infectious disease positive serum like HIV, HBV, HCV positive serum which are to be supplied to the IVD kits manufacturer are regulated in EUROPE and other GHTF countries..?

  • @ayonghosh8478
    @ayonghosh84783 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Nice Vedio,,

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Thanks Ayon

  • @velmuruganp9255
    @velmuruganp92554 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Sir for non medical products do we need any licence to run the shop and what type of licence we have to take for sales

  • @rajatkohli7141
    @rajatkohli71415 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Thanks you for sharing

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Thanks

  • @himanshiarora7681
    @himanshiarora76813 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    nice video please upload more videos on regulatory affairs syllabus

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Sure Himanshi

  • @nainamdixit9720
    @nainamdixit97203 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    I also need some sample document related to iso 14971 , can you please support . Thanks

  • @stdioconio999
    @stdioconio9992 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Spectacle glasses will fall under which class and does class I have further sub categories?

  • @DigitalELearning

    @DigitalELearning

    2 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Class 1 device and there is no further sub category

  • @harshitrastogi2473
    @harshitrastogi24733 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Sir you hv to make another video because background music disturb as well as down your voice

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Sure will work on your feedback

  • @vmangoli
    @vmangoli ะ–ั‹ะป ะฑาฑั€ั‹ะฝ

    Hello, do you help completing medical device licencing formalities?

  • @DigitalELearning

    @DigitalELearning

    ะ–ั‹ะป ะฑาฑั€ั‹ะฝ

    No Sorry

  • @avinashsokhi942
    @avinashsokhi9422 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Hi, a question at 4:26 They are 510kc...what is kc?

  • @DigitalELearning

    @DigitalELearning

    2 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Hi Avinash, this was a typo. It 510k only

  • @monetpiedad7611
    @monetpiedad76112 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Hello. Can we import medical devices even if we are not a medical company?

  • @DigitalELearning

    @DigitalELearning

    2 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Probably yes but need some lisence to import

  • @vijaykiran2167
    @vijaykiran21674 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    hi is there any video in IEC 62304

  • @DigitalELearning

    @DigitalELearning

    4 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Hi Vijay, as it is not there but I will definitely add it soon

  • @sujayd7142
    @sujayd71423 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Nice video but the sound and the floating images are distracting makes it hard to concentrate. Can you please try to reduce that. People have difficulty focussing so things like this distract people even more.

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Sure will work on this

  • @bhaveshchoudhary8421
    @bhaveshchoudhary84213 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Sir manufacturing medical device open Karne ke liye b.pharm is enough or we have to do m.pharm ?

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    This is a regualted industry , definately just having this is not enough. There may be other requirments You can check the web for same

  • @bhaveshchoudhary8421

    @bhaveshchoudhary8421

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    @@DigitalELearning thank u sir

  • @adithyaasrinivaas1445
    @adithyaasrinivaas14453 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Good info...but, pls stop the background music ...your voice is not audible bit

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Feedback noted

  • @nainamdixit9720
    @nainamdixit97203 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Nice video , may I have the list of restticted material for the material compliance .

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Nainam, I dont have that handy but you can check that in google. If I find anything I will reply here

  • @nainamdixit9720

    @nainamdixit9720

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    @@DigitalELearning ok thanks

  • @umamaheswari1129
    @umamaheswari11292 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    is it need any special qualification to start this

  • @DigitalELearning

    @DigitalELearning

    2 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    To start what ? Can you be more specific

  • @HamzaHajeir
    @HamzaHajeir3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    nice content, but lot of noise is out there

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Thanks ...will work on this feedback

  • @srikarsarakallu2607
    @srikarsarakallu26072 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Pl remove background music, its not clear with the music

  • @DigitalELearning

    @DigitalELearning

    2 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Feedback Noted

  • @finmaxx
    @finmaxx2 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    The music makes it hard to hear . No music more subscribers

  • @DigitalELearning

    @DigitalELearning

    2 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Feedback noted โœ…

  • @zakariahlafreniere1332
    @zakariahlafreniere13322 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    is this in Chinese?

  • @DigitalELearning

    @DigitalELearning

    2 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    No

  • @saurabhsonawane1683
    @saurabhsonawane16833 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Please remove advertisement

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Feedback noted. Thanks :)

  • @jenran39
    @jenran393 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    He is talking way too fast and that music is distracting... I couldn't watch it

  • @DigitalELearning

    @DigitalELearning

    3 ะถั‹ะป ะฑาฑั€ั‹ะฝ

    Feedback notes

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