Тёмный
RegDesk
RegDesk
RegDesk
Подписаться
RegDesk is a holistic Regulatory Information Management System that provides medical device companies with regulatory intelligence for over 120 markets worldwide. We help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Our software can help you alleviate the risk of missing key regulatory notifications and deadlines, reduce submission preparation time from several months to hours, easily report on KPI's and help you maintain compliance. Global expansion has never been this simple.

Our RU-vid channel aims to bring you webinars with experts from the MedTech industry and other edutainment content. Stay tuned!
Essential Alerts 10:  May 31, 2024
2:04
3 месяца назад
Webinar Mexico COFEPRIS updates    SD 480p
32:26
5 месяцев назад
Комментарии
@lalitha96
@lalitha96 16 дней назад
How to get the material/ppt
@pinaki1041
@pinaki1041 4 месяца назад
I need detailsto register
@user-yn7kr7bv8u
@user-yn7kr7bv8u 6 месяцев назад
I think your videos are very useful for RA. If you don't mind, I would like to ask your permission to share your videos to the other website in China for the embarrassing reason that RU-vid is blocked from accessing in China. Of course, I will give sources of the original website. Thank you very much!
@user-yn7kr7bv8u
@user-yn7kr7bv8u 6 месяцев назад
I think your videos are very useful for RA. If you don't mind, I would like to ask your permission to share your videos to the other website in China for the embarrassing reason that RU-vid is blocked from accessing in China. Of course, I will give sources of the original website. Thank you very much!
@6brman224
@6brman224 8 месяцев назад
Watch MHRA board meetings. June Raine said they are now an enabling agency, revolving door with big pharma. None of you are trusted after the last 3 years, the farther you stay from me the happier I'll be. None of your made up rules apply to me.
@nakfurtulubka14
@nakfurtulubka14 Год назад
Thank you for the informative presentation. Could you answer me, how european manufacturere handle the current situation with the proposal of the MDR. As you know there a two ways. The Notified Body should write a Confirmation letter for the manufacturer or themanufacture must write a own statement. But the Notified Bodies are currently not ready beacuse they must implement this proposal in their own process. This takes time. But if the manufacturer has no CE Certification acc. MDR and the valid MDD Certification will expired in the next time, how could manufacturer extend the registration in Saudi without the Confirmation Letter?. Accept SFDA/KSA self-written statements? Thank you.
@nusrathbaig6902
@nusrathbaig6902 Год назад
Thank you for having an informative presentation. I would like to learn how in ghad system we can choose TFA route. Is it same as MDMA selection then which jurisdiction we have to choose if no ghtf route
@baraanofal1640
@baraanofal1640 10 месяцев назад
In Ghad system the MDMA it is same as TFA that incudes the new regulation to include the technical file, I just say TFA to refer for the technical file documentation, MDMA: mean Marketing Authorization of Medical Devices in Saudi Arabia. So in the Ghad portal you will chose MDMA to apply for your application and completing your file.
@Abinradh
@Abinradh Год назад
Dear Maam, Is it possible to share the presentation file here. It would be very helpfull for us.
@regdeskrims
@regdeskrims Год назад
Please provide your company email so that we can share the presentation slides with you. Thank you.
@alliebart3300
@alliebart3300 2 года назад
Nice video, I put on my Freestyle Libre 14days glucose sensor with NightRider! It's so good because 1) It shows if your sugars are trending up or down. 2) Give alarms if you go too low or too high. It is an amazing tool.
@alexanderwong3510
@alexanderwong3510 3 года назад
i want to register covid-19 antigen tests ,please contact me 86 18761880911
@lousheehan9825
@lousheehan9825 3 года назад
Thank you for this. Might you also send us a compendium of the e-mail questions and answers?
@Cupcakeforever123
@Cupcakeforever123 3 года назад
Hi Priya, this was indeed a very useful webinar, however as you promised in the end of this video, kindly conduct more webinars covering Saudi FDA specially the new rules & regulations. Thanks a Lot.
@lablinkspk
@lablinkspk 3 года назад
Please give me your contact number
@unamcdonagh4396
@unamcdonagh4396 3 года назад
What is the name of draft guidance
@SMARTSServices
@SMARTSServices 3 года назад
SMARTS Services is a company which provide low cost regulatory consultancy services to get product registration from Drug Regulatory Authority of Pakistan (DRAP), Ministry of National Health Services Regulations & Coordination Islamabad, Pakistan. If you have any queries or require any further information please do not hesitate to contact us 24/7 at cell # 0333-4776655 or e-mail at smartssmarts@gmail.com or visit www.drapregistration.com
@rohitramakantshukla1753
@rohitramakantshukla1753 5 лет назад
Satyam Kothari and sash modiya