Artwork

Nội dung được cung cấp bởi Monir El Azzouzi. Tất cả nội dung podcast bao gồm các tập, đồ họa và mô tả podcast đều được Monir El Azzouzi hoặc đối tác nền tảng podcast của họ tải lên và cung cấp trực tiếp. Nếu bạn cho rằng ai đó đang sử dụng tác phẩm có bản quyền của bạn mà không có sự cho phép của bạn, bạn có thể làm theo quy trình được nêu ở đây https://vi.player.fm/legal.
Player FM - Ứng dụng Podcast
Chuyển sang chế độ ngoại tuyến với ứng dụng Player FM !

Medical Device News: March 2023 Regulatory Update

 
Chia sẻ
 

Manage episode 357297548 series 2591977
Nội dung được cung cấp bởi Monir El Azzouzi. Tất cả nội dung podcast bao gồm các tập, đồ họa và mô tả podcast đều được Monir El Azzouzi hoặc đối tác nền tảng podcast của họ tải lên và cung cấp trực tiếp. Nếu bạn cho rằng ai đó đang sử dụng tác phẩm có bản quyền của bạn mà không có sự cho phép của bạn, bạn có thể làm theo quy trình được nêu ở đây https://vi.player.fm/legal.

Here is your Regulatory Update for the month of March 2023.

Check all the links on Medboard Platform: https://www.medboard.com/reports/easy-medical-device-regulatory-update/2023/march/

EU MDR 2017/745 extension has been voted: https://www.raps.org/news-and-articles/news-articles/2023/2/europeanparliament-votes-to-extend-mdr-transition

-UK Impact of extension of Medical Device Regulations transitional period and the validity of Certificated in the EU:

https://www.gov.uk/government/news/impact-of-extension-of-medical-device-regulations-transitional-period-and-thevalidity-of-certificates-in-the-eu

-Ireland – Article 97 request form : https://www.hpra.ie/homepage/about-us/publications-forms/forms-applications/item? id=e4cb1326-9782-6eee-9b55-ff00008c97d0

-EU Team-NB. Best practice Guidance for the submission of Technical Documentation for IVDR: https://www.teamnb.org/team-nb-pp-best-practice-guidance-for-the-submission-of-technical-documentation-under-annex-ii-and-iii-of-in-vitrodiagnostic-medical-devices-regulation/

-EU Team-NB . IVDR technical Documentation training for manufacturers: Wednesday June 14th, 2023 https://www.teamnb.org/wp-content/uploads/members/M2023/Leaflet-IVD-TC-Manufacturers-Training-

-EMA pilots scientific advice for certain High-Risk Medical Devices: https://www.ema.europa.eu/en/news/ema-pilotsscientific-advice-certain-high-risk-medical-devices

– New Notified Bodies

○ NSAI for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id= 321463&version_no=10

○ MDC for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id= 321397&version_no=8

-Spain AEMPS: Notice addressed to Notified Bodies and Manufacturers of Nasal Sprays with Virucidal or Microbicidal action: https://www.aemps.gob.es/informa/la-aemps-publica-una-nota-de-aviso-dirigida-a-organismos-notificados-y-a-fabricantesde-esprais-nasales-con-accion-viricida-o-microbicida/

-Swiss – Q&A for IVD notification:

/search-fdaguidance-documents/guidance-industry-and-food-and-drug-administration-staff-assemblers-guide-diagnostic-xray-equipment

Performance standard for Diagnostic X-Ray systems. https://www.fda.gov/regulatory-information/search-fdaguidance-documents/performance-standard-diagnostic-x-ray-systems-and-their-majorcomponents-21cfr-102030-102031-102032

-Medical X-ray imaging devices coformance with IEC Standards: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-x-ray-imaging-devices-conformance-iec-standards

-List of cleared Companion Diagnostic: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-orapproved-companion-diagnostic-devices-in-vitro-and-imaging-tools

-US Medsun February 2023: https://www.fda.gov/media/165125/download

-SAUDI-DI Webinar March 20th 2023 https://www.sfda.gov.sa/en/workshop/87814

-Link to Webex: https://zoom.us/j/95729656046?pwd=NmNOLzZYT0hmK3JqVXhPQ25LQmQ5Zz09

-Link to Webex: https://zoom.us/j/93572022832?pwd=K1ZVL2xTNXFHV3NEdXVGbk4yN0Z3Zz09

South Africa. SAPHRA Q&A on Licensing of Medical Device establishment: https://www.sahpra.org.za/wpcontent/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device-

Establishments.pdf

○ Episode 219 – Biological Evaluation: Top Big Mistakes (Paul Fernandes and Laura Fouzari) https://podcast.easymedicaldevice.com/219-2/

○ Episode 220 – SaMD International Reach (Stephane Berger) https://podcast.easymedicaldevice.com/220-2/

○ Episode 221 – Prepare your transition from Class I to Class Ir https://podcast.easymedicaldevice.com/221-2/

○ LinkedIn Live – Samd Class I – To be published this week

► Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

■ Twitter: https://twitter.com/elazzouzim

■ Pinterest: https://www.pinterest.com/easymedicaldevice

■ Instagram: https://www.instagram.com/easymedicaldevice

miniature episode 222 medical device news march 2023 update easy medical device monir el azzouzi

The post Medical Device News: March 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

  continue reading

286 tập

Artwork
iconChia sẻ
 
Manage episode 357297548 series 2591977
Nội dung được cung cấp bởi Monir El Azzouzi. Tất cả nội dung podcast bao gồm các tập, đồ họa và mô tả podcast đều được Monir El Azzouzi hoặc đối tác nền tảng podcast của họ tải lên và cung cấp trực tiếp. Nếu bạn cho rằng ai đó đang sử dụng tác phẩm có bản quyền của bạn mà không có sự cho phép của bạn, bạn có thể làm theo quy trình được nêu ở đây https://vi.player.fm/legal.

Here is your Regulatory Update for the month of March 2023.

Check all the links on Medboard Platform: https://www.medboard.com/reports/easy-medical-device-regulatory-update/2023/march/

EU MDR 2017/745 extension has been voted: https://www.raps.org/news-and-articles/news-articles/2023/2/europeanparliament-votes-to-extend-mdr-transition

-UK Impact of extension of Medical Device Regulations transitional period and the validity of Certificated in the EU:

https://www.gov.uk/government/news/impact-of-extension-of-medical-device-regulations-transitional-period-and-thevalidity-of-certificates-in-the-eu

-Ireland – Article 97 request form : https://www.hpra.ie/homepage/about-us/publications-forms/forms-applications/item? id=e4cb1326-9782-6eee-9b55-ff00008c97d0

-EU Team-NB. Best practice Guidance for the submission of Technical Documentation for IVDR: https://www.teamnb.org/team-nb-pp-best-practice-guidance-for-the-submission-of-technical-documentation-under-annex-ii-and-iii-of-in-vitrodiagnostic-medical-devices-regulation/

-EU Team-NB . IVDR technical Documentation training for manufacturers: Wednesday June 14th, 2023 https://www.teamnb.org/wp-content/uploads/members/M2023/Leaflet-IVD-TC-Manufacturers-Training-

-EMA pilots scientific advice for certain High-Risk Medical Devices: https://www.ema.europa.eu/en/news/ema-pilotsscientific-advice-certain-high-risk-medical-devices

– New Notified Bodies

○ NSAI for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id= 321463&version_no=10

○ MDC for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id= 321397&version_no=8

-Spain AEMPS: Notice addressed to Notified Bodies and Manufacturers of Nasal Sprays with Virucidal or Microbicidal action: https://www.aemps.gob.es/informa/la-aemps-publica-una-nota-de-aviso-dirigida-a-organismos-notificados-y-a-fabricantesde-esprais-nasales-con-accion-viricida-o-microbicida/

-Swiss – Q&A for IVD notification:

/search-fdaguidance-documents/guidance-industry-and-food-and-drug-administration-staff-assemblers-guide-diagnostic-xray-equipment

Performance standard for Diagnostic X-Ray systems. https://www.fda.gov/regulatory-information/search-fdaguidance-documents/performance-standard-diagnostic-x-ray-systems-and-their-majorcomponents-21cfr-102030-102031-102032

-Medical X-ray imaging devices coformance with IEC Standards: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-x-ray-imaging-devices-conformance-iec-standards

-List of cleared Companion Diagnostic: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-orapproved-companion-diagnostic-devices-in-vitro-and-imaging-tools

-US Medsun February 2023: https://www.fda.gov/media/165125/download

-SAUDI-DI Webinar March 20th 2023 https://www.sfda.gov.sa/en/workshop/87814

-Link to Webex: https://zoom.us/j/95729656046?pwd=NmNOLzZYT0hmK3JqVXhPQ25LQmQ5Zz09

-Link to Webex: https://zoom.us/j/93572022832?pwd=K1ZVL2xTNXFHV3NEdXVGbk4yN0Z3Zz09

South Africa. SAPHRA Q&A on Licensing of Medical Device establishment: https://www.sahpra.org.za/wpcontent/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device-

Establishments.pdf

○ Episode 219 – Biological Evaluation: Top Big Mistakes (Paul Fernandes and Laura Fouzari) https://podcast.easymedicaldevice.com/219-2/

○ Episode 220 – SaMD International Reach (Stephane Berger) https://podcast.easymedicaldevice.com/220-2/

○ Episode 221 – Prepare your transition from Class I to Class Ir https://podcast.easymedicaldevice.com/221-2/

○ LinkedIn Live – Samd Class I – To be published this week

► Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

■ Twitter: https://twitter.com/elazzouzim

■ Pinterest: https://www.pinterest.com/easymedicaldevice

■ Instagram: https://www.instagram.com/easymedicaldevice

miniature episode 222 medical device news march 2023 update easy medical device monir el azzouzi

The post Medical Device News: March 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

  continue reading

286 tập

Tất cả các tập

×
 
Loading …

Chào mừng bạn đến với Player FM!

Player FM đang quét trang web để tìm các podcast chất lượng cao cho bạn thưởng thức ngay bây giờ. Đây là ứng dụng podcast tốt nhất và hoạt động trên Android, iPhone và web. Đăng ký để đồng bộ các theo dõi trên tất cả thiết bị.

 

Hướng dẫn sử dụng nhanh