Medical Devices classification as per FDA | Medical Device Regulations |

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  • เผยà¹à¸žà¸£à¹ˆà¹€à¸¡à¸·à¹ˆà¸­ 24 มิ.ย. 2024
  • 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.
    â±ï¸ ð‘»ð’Šð’Žð’† ð‘ºð’•ð’‚ð’Žð’‘ â±ï¸
    -------------------------------
    0:00 - Introduction
    📖 ððžð¬ð­ ðð¨ð¨ð¤ ð¨ð§ ð€ð¦ðšð³ð¨ð§ ( 🎭 ðŒð®ð¬ð­ ð‘ðžðšð )
    ------------------------------------------------------------------------------
    🚩 ð–ð¨ð«ð¥ð’ð¬ ð†ð«ðžðšð­ðžð¬ð­ ðð¨ð¨ð¤ð¬ ð…ð¨ð« ððžð«ð¬ð¨ð§ðšð¥ ð†ð«ð¨ð°ð­ð¡ & ð–ðžðšð¥ð­ð¡
    ----------------------------------------------
    - ð”ð’ð€ users Click Here to Buy : amzn.to/3kYQcaE
    - ð”ðŠ users Click Here to Buy : amzn.to/3iPZuTM
    - ð‚ðšð§ðšððš users Click Here to Buy: amzn.to/3iQdzRd
    - ð€ð®ð¬ð­ð«ðšð¥ð¢ðš users Click Here to Buy : amzn.to/3ftRDKS
    - ðˆð§ðð¢ðš users Click Here to Buy : amzn.to/373Babq
    🚩 ððžð ð¢ð§ð§ðžð«'ð¬ ð†ð®ð¢ððž ð­ð¨ ð‹ðžðšð§ ð’ð¢ð± ð’ð¢ð ð¦ðš
    ------------------------------------------------------
    - ð”ð’ð€ users Click Here to Buy : amzn.to/3xGojaQ
    - ð”ðŠ users Click Here to Buy : amzn.to/36R9Vkx
    - ð‚ðšð§ðšððš users Click Here to Buy : amzn.to/3yX2ynq
    - ð€ð®ð¬ð­ð«ðšð¥ð¢ðš users Click Here to Buy : amzn.to/3AcjhDI
    - ðˆð§ðð¢ðš users Click Here to Buy : amzn.to/3rnXpm1
    🚩 🕠ð‡ðšð›ð¢ð­ð¬ ð¨ðŸ ð‡ð¢ð ð¡ð¥ð² ð„ðŸðŸðžðœð­ð¢ð¯ðž ððžð¨ð©ð¥ðž
    ------------------------------------------------------
    - ð”ð’ð€ users Click Here to Buy : amzn.to/3z3uh5N
    - ð”ðŠ users Click Here to Buy : amzn.to/3wIuDNV
    - ð‚ðšð§ðšððš users Click Here to Buy: amzn.to/3z1FvI2
    - ð€ð®ð¬ð­ð«ðšð¥ð¢ðš users Click Here to Buy : amzn.to/3jomCca
    - ðˆð§ðð¢ðš users Click Here to Buy : amzn.to/2URc78w
    🚩 ð‹ðžðšð§ ð’ð¢ð± ð’ð¢ð ð¦ðš ðšð§ð ðŒð¢ð§ð¢ð­ðšð› - ð‚ð¨ð¦ð©ð¥ðžð­ðž ð ð®ð¢ððž
    ---------------------------------------------------------------------
    - ð”ð’ð€ users Click Here to Buy : amzn.to/3z65RZL
    - ð”ðŠ users Click Here to Buy : amzn.to/3kguvma
    - ð‚ðšð§ðšððš users Click Here to Buy: amzn.to/3i6kDZu
    - ð€ð®ð¬ð­ð«ðšð¥ð¢ðš users Click Here to Buy : amzn.to/3CdwZIy
    - ðˆð§ðð¢ðš users Click Here to Buy : amzn.to/3i5El7u
    🚩 ð‹ðžðšð§ ð’ð¢ð± ð’ð¢ð ð¦ðš ð…ð¨ð« ðƒð®ð¦ð¦ð¢ðžð¬
    ----------------------------------------------
    - ð”ð’ð€ users Click Here to Buy : amzn.to/3r9o1Hc
    - ð”ðŠ users Click Here to Buy : amzn.to/3itqxEn
    - ð‚ðšð§ðšððš users Click Here to Buy: amzn.to/3kjVLA2
    - ð€ð®ð¬ð­ð«ðšð¥ð¢ðš users Click Here to Buy : amzn.to/3jgFBp4
    - ðˆð§ðð¢ðš users Click Here to Buy : amzn.to/3xKf5dH
    🚩 ð‹ðžðšð§ ðð«ð¨ðð®ðœð­ð¢ð¨ð§ ð’ð¢ð¦ð©ð¥ð¢ðŸð¢ðžð: ð–ð¨ð«ð¥ð'ð¬ ðŒð¨ð¬ð­ ðð¨ð°ðžð«ðŸð®ð¥ ðð«ð¨ðð®ðœð­ð¢ð¨ð§ ð’ð²ð¬ð­ðžð¦
    ----------------------------------------------
    - ð”ð’ð€ users Click Here to Buy : amzn.to/3ilTovi
    - ð”ðŠ users Click Here to Buy : amzn.to/2TTqYiV
    - ð‚ðšð§ðšððš users Click Here to Buy: amzn.to/3rQxm6W
    - ð€ð®ð¬ð­ð«ðšð¥ð¢ðš users Click Here to Buy : amzn.to/37iRBkf
    - ðˆð§ðð¢ðš users Click Here to Buy : amzn.to/3ftwaSc
    📢📢 📢📢 ð…ð¨ð¥ð¥ð¨ð°ð¬ ð®ð¬ ð¨ð§ ð‘ºð’ð’„ð’Šð’‚ð’ ð‘´ð’†ð’…ð’Šð’‚
    -------------------------------------------------------------------------
    ðŸ¦ð“ð°ð¢ð­ð­ðžð« : / digitalelearni1
    📸 ðˆð§ð¬ð­ðšð ð«ðšð¦ : / digital_elearning
    📩 ð“ðžð¥ðžð ð«ðšð¦ : t.me/digital_e_learning007
    🙋ðŸ»â€â™‚ï¸ ðð¢ð§ð­ð«ðžð¬ð­: / digitalelearning007
    🙋ðŸ»â€â™‚ï¸ ð‹ð¢ð§ð¤ðžððˆð§ ððšð ðž: / 55180987
    🙋ðŸ»â€â™‚ï¸ ð…ðšðœðžð›ð¨ð¨ð¤ ððšð ðž : / digitalelearni1
    💌 ð‘ªð’ð’ð’•ð’‚ð’„ð’• ð’–ð’” : digital.e.learning007@gmail.com for any business/ promotion queries.
    âœï¸ ð““ð“²ð“¼ð“¬ð“µð“ªð“²ð“¶ð“®ð“»:
    Copyright Disclaimer under section 107 of the Copyright Act of 1976, allowance is made for “fair use†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 TH-cam community guidelines or policy. I respect and follow all terms & conditions of Google & TH-cam.
    ð‚ð¨ð¦ð¦ð¨ð§ ðŠðžð² ð¬ðžðšð«ðœð¡ ð«ðžð¥ðšð­ðžð ð­ð¨ ð­ð¡ð¢ð¬ ð­ð¨ð©ð¢ðœ :
    ----------------------------------------------------------------------

ความคิดเห็น • 73

  • @DigitalELearning
    @DigitalELearning  5 ปีที่à¹à¸¥à¹‰à¸§ +5

    👀 Hello Friends, ð‰ð¨ð¢ð§ my ð‘ºð’ð’„ð’Šð’‚ð’ ð‘´ð’†ð’…ð’Šð’‚ ð‘³ð’Šð’𒌠for regular updates:
    ------------------------------------------------------------------------------------------------------------------
    📸ðˆð§ð¬ð­ðšð ð«ðšð¦ : instagram.com/digital_elearning/
    ðŸ¦ð“ð°ð¢ð­ð­ðžð«: twitter.com/DigitalELEARNI1
    📢ð“ðžð¥ðžð ð«ðšð¦ : t.me/digital_e_learning007
    🙋ðŸ»â€â™‚ð–ð¡ðšð­ð¬ð€ð©ð© (ð‹ðžðšð§ ð¬ð¢ð± ð¬ð¢ð ð¦ðš) : whatsapp.com/channel/0029VaAUuqs4inooet3e4S3O
    🙋ðŸ»â€â™‚ð–ð¡ðšð­ð¬ð€ð©ð© (ð’ð¢ð± ð’ð¢ð ð¦ðš (ðŸ”σ ) : whatsapp.com/channel/0029VaEWKWbIiRovZpAduc0p
    🙋ðŸ»â€â™‚ð–ð¡ðšð­ð¬ð€ð©ð© (ð’ð­ðšð­ð¢ð¬ð­ð¢ðœð¬ & ð‘ðžð¬ðžðšð«ðœð¡) :whatsapp.com/channel/0029VaAGwzTDJ6H9S5Q4Ow0m
    🙋ðŸ»â€â™‚ð–ð¡ðšð­ð¬ð€ð©ð© (ðð«ð¨ð£ðžðœð­ ðŒðšð§ðšð ðžð¦ðžð§ð­) :whatsapp.com/channel/0029Va8slQdEAKWAhXoQK13B
    🙋ðŸ»â€â™‚ð–ð¡ðšð­ð¬ð€ð©ð© (ðð®ðšð¥ð¢ð­ð² ð€ð¬ð¬ð®ð«ðšð§ðœðž & ðð®ðšð¥ð¢ð­ð² ð‚ð¨ð§ð­ð«ð¨ð¥) :whatsapp.com/channel/0029VaAKJBGKGGGDjcK4mw2h

    • @vivaanbo3905
      @vivaanbo3905 2 ปีที่à¹à¸¥à¹‰à¸§

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

    • @kelvinspencer6971
      @kelvinspencer6971 2 ปีที่à¹à¸¥à¹‰à¸§

      @Vivaan Bo Flixportal :)

    • @vivaanbo3905
      @vivaanbo3905 2 ปีที่à¹à¸¥à¹‰à¸§

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

    • @kelvinspencer6971
      @kelvinspencer6971 2 ปีที่à¹à¸¥à¹‰à¸§

      @Vivaan Bo happy to help :D

  • @fazil264
    @fazil264 3 ปีที่à¹à¸¥à¹‰à¸§ +14

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

    • @DigitalELearning
      @DigitalELearning  3 ปีที่à¹à¸¥à¹‰à¸§ +3

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

    • @fazil264
      @fazil264 3 ปีที่à¹à¸¥à¹‰à¸§ +1

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

    • @DigitalELearning
      @DigitalELearning  3 ปีที่à¹à¸¥à¹‰à¸§

      Thanks for supporting

  • @rajatkohli7141
    @rajatkohli7141 4 ปีที่à¹à¸¥à¹‰à¸§ +5

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

    • @DigitalELearning
      @DigitalELearning  3 ปีที่à¹à¸¥à¹‰à¸§

      Thanks for watching.. 😀📺

  • @TheShubhamdel06
    @TheShubhamdel06 2 ปีที่à¹à¸¥à¹‰à¸§

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

    • @DigitalELearning
      @DigitalELearning  2 ปีที่à¹à¸¥à¹‰à¸§

      Glad it was helpful! Thanks 😎

  • @shilpatil29
    @shilpatil29 2 ปีที่à¹à¸¥à¹‰à¸§ +1

    Very nice explanation for beginners, thanks for sharing ðŸ‘

    • @DigitalELearning
      @DigitalELearning  2 ปีที่à¹à¸¥à¹‰à¸§ +1

      Glad you liked it

  • @rohan5753
    @rohan5753 24 วันที่ผ่านมา +1

    nice informative video

    • @DigitalELearning
      @DigitalELearning  22 วันที่ผ่านมา

      Thanks ðŸ‘

  • @anoopbaghel7866
    @anoopbaghel7866 3 ปีที่à¹à¸¥à¹‰à¸§ +1

    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..?

  • @dayabachala2859
    @dayabachala2859 à¸›à¸µà¸—ี่à¹à¸¥à¹‰à¸§

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

  • @velmuruganp9255
    @velmuruganp9255 4 ปีที่à¹à¸¥à¹‰à¸§ +1

    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

  • @gorakhghuge6522
    @gorakhghuge6522 3 ปีที่à¹à¸¥à¹‰à¸§

    Very nice information. Thank you..

    • @DigitalELearning
      @DigitalELearning  3 ปีที่à¹à¸¥à¹‰à¸§

      Thanks Gorakh

  • @himanshiarora7681
    @himanshiarora7681 3 ปีที่à¹à¸¥à¹‰à¸§ +1

    nice video please upload more videos on regulatory affairs syllabus

    • @DigitalELearning
      @DigitalELearning  3 ปีที่à¹à¸¥à¹‰à¸§

      Sure Himanshi

  • @ayonghosh8478
    @ayonghosh8478 3 ปีที่à¹à¸¥à¹‰à¸§ +1

    Nice Vedio,,

  • @sumantiwari4985
    @sumantiwari4985 6 หลายเดือนà¸à¹ˆà¸­à¸™ +1

    Thanks a lot ðŸ™ðŸ»

    • @DigitalELearning
      @DigitalELearning  6 หลายเดือนà¸à¹ˆà¸­à¸™

      You're welcome 😊

  • @rajatkohli7141
    @rajatkohli7141 5 ปีที่à¹à¸¥à¹‰à¸§

    Thanks you for sharing

  • @lopeztaylor994
    @lopeztaylor994 5 ปีที่à¹à¸¥à¹‰à¸§

    Great job.

  • @nainamdixit9720
    @nainamdixit9720 3 ปีที่à¹à¸¥à¹‰à¸§ +1

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

  • @stdioconio999
    @stdioconio999 2 ปีที่à¹à¸¥à¹‰à¸§

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

    • @DigitalELearning
      @DigitalELearning  à¸›à¸µà¸—ี่à¹à¸¥à¹‰à¸§

      Class 1 device and there is no further sub category

  • @harshitrastogi2473
    @harshitrastogi2473 3 ปีที่à¹à¸¥à¹‰à¸§ +2

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

    • @DigitalELearning
      @DigitalELearning  3 ปีที่à¹à¸¥à¹‰à¸§

      Sure will work on your feedback

  • @vmangoli
    @vmangoli à¸›à¸µà¸—ี่à¹à¸¥à¹‰à¸§

    Hello, do you help completing medical device licencing formalities?

  • @monetpiedad7611
    @monetpiedad7611 2 ปีที่à¹à¸¥à¹‰à¸§

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

    • @DigitalELearning
      @DigitalELearning  2 ปีที่à¹à¸¥à¹‰à¸§

      Probably yes but need some lisence to import

  • @avinashsokhi942
    @avinashsokhi942 2 ปีที่à¹à¸¥à¹‰à¸§

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

    • @DigitalELearning
      @DigitalELearning  2 ปีที่à¹à¸¥à¹‰à¸§ +1

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

  • @bhaveshchoudhary8421
    @bhaveshchoudhary8421 3 ปีที่à¹à¸¥à¹‰à¸§

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

    • @DigitalELearning
      @DigitalELearning  3 ปีที่à¹à¸¥à¹‰à¸§

      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 ปีที่à¹à¸¥à¹‰à¸§

      @@DigitalELearning thank u sir

  • @vijaykiran2167
    @vijaykiran2167 4 ปีที่à¹à¸¥à¹‰à¸§

    hi is there any video in IEC 62304

    • @DigitalELearning
      @DigitalELearning  4 ปีที่à¹à¸¥à¹‰à¸§ +1

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

  • @sujayd7142
    @sujayd7142 3 ปีที่à¹à¸¥à¹‰à¸§

    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 ปีที่à¹à¸¥à¹‰à¸§ +1

      Sure will work on this

  • @umamaheswari1129
    @umamaheswari1129 2 ปีที่à¹à¸¥à¹‰à¸§

    is it need any special qualification to start this

    • @DigitalELearning
      @DigitalELearning  2 ปีที่à¹à¸¥à¹‰à¸§

      To start what ? Can you be more specific

  • @adithyaasrinivaas1445
    @adithyaasrinivaas1445 3 ปีที่à¹à¸¥à¹‰à¸§

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

    • @DigitalELearning
      @DigitalELearning  3 ปีที่à¹à¸¥à¹‰à¸§

      Feedback noted

  • @nainamdixit9720
    @nainamdixit9720 3 ปีที่à¹à¸¥à¹‰à¸§ +1

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

    • @DigitalELearning
      @DigitalELearning  3 ปีที่à¹à¸¥à¹‰à¸§ +1

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

    • @nainamdixit9720
      @nainamdixit9720 3 ปีที่à¹à¸¥à¹‰à¸§

      @@DigitalELearning ok thanks

  • @HamzaHajeir
    @HamzaHajeir 3 ปีที่à¹à¸¥à¹‰à¸§

    nice content, but lot of noise is out there

    • @DigitalELearning
      @DigitalELearning  3 ปีที่à¹à¸¥à¹‰à¸§

      Thanks ...will work on this feedback

  • @srikarsarakallu2607
    @srikarsarakallu2607 2 ปีที่à¹à¸¥à¹‰à¸§

    Pl remove background music, its not clear with the music

    • @DigitalELearning
      @DigitalELearning  à¸›à¸µà¸—ี่à¹à¸¥à¹‰à¸§

      Feedback Noted

  • @finmaxx
    @finmaxx 2 ปีที่à¹à¸¥à¹‰à¸§

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

    • @DigitalELearning
      @DigitalELearning  2 ปีที่à¹à¸¥à¹‰à¸§

      Feedback noted ✅

  • @zakariahlafreniere1332
    @zakariahlafreniere1332 2 ปีที่à¹à¸¥à¹‰à¸§

    is this in Chinese?

  • @saurabhsonawane1683
    @saurabhsonawane1683 3 ปีที่à¹à¸¥à¹‰à¸§

    Please remove advertisement

    • @DigitalELearning
      @DigitalELearning  3 ปีที่à¹à¸¥à¹‰à¸§

      Feedback noted. Thanks :)

  • @jenran39
    @jenran39 3 ปีที่à¹à¸¥à¹‰à¸§

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

    • @DigitalELearning
      @DigitalELearning  3 ปีที่à¹à¸¥à¹‰à¸§

      Feedback notes