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RE: India plant master file requirement for medical devices

Posted by:Nilesh Rajule, an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

Hello Priya, There is no guidance on the time interval to update the Plant Master File (PMF). Since this document is included along with the Quality Manual requirements, it needs to stay current. read more
RE: Biological evaluation of reusable medical devices: What role does shelf-life play?

Posted by:Stephanie Christianson, 2 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Saschka, There has definitely been some great discussion especially regarding reprocessing/useful life. Here are a few resources I like to keep handy: https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/sterilization-of-medical-devices2/ read more
RE: Marketing Authorization Application in the UK post Brexit and Swissmedic

Posted by:Stephanie Christianson, 2 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Anne, For the UK: For Devices: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1137842/Device_Registration_Reference_Guide_Feb_2023_Final_v1.pdf read more
Marketing Authorization Application in the UK post Brexit and Swissmedic

Posted by:Anne Njapa, 18 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Hi All Does anyone has any recent experience with the Market Authorization Application submission requirements in the UK and Swissmedic timelines as their websites are a bit confusing to me. Any recent read more
RE: HELP - Homeopathic monograph

Posted by:Anne LeBlanc, 23 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Or maybe that would qualify as a 1X dilution. Some examples: https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=arnica ------------------------------ Anne LeBlanc United States read more

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China Medical Electrical Standards Effective May 1, ...

By: Grace Fu Palma , 2 days ago

Posted in: Regulatory Open Forum

On March 16, 2023, China NMPA issued the "Notice on Implementation of GB 9706.1-2020 and Supporting Standards", equivalent to IEC60601 with effective date of May 1 st , 2023. Good news for active product manufacturers with existing NMPA certificates, ...

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Health Canada DEL - Domestic FDF products

By: Anonymous Member , 2 days ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Hello, I would like to have an advise from someone with the HC DEL experience. In the Section 4.0 - Domestic FDF class product information, which Finished products have to be listed ...
ANVISA Regulations for Annual Reports

By: Olivia Combs , 2 days ago

Posted in: Regulatory Open Forum

Hello, I am looking for ANVISA's Regulations on Annual Reports and what is required at minimum to be submitted. If possible, I am looking for something similar to the FDA guidelines, if it exists. I have searched ANVISA's site but have not found the guidelines. ...
ATEX Training

By: Rohan Wadhwa , 2 days ago

Posted in: Regulatory Open Forum

Hi all, Does anyone have any recommendations for ATEX training? I am ideally looking for a one day program which covers basic ATEX and/or Hazloc directive requirements. Any suggestions welcome. Best Regards, Rohan ------------------------------ ...
SF Chapter Webinar: 4th April, Tuesday 12-1 pm PT Clinical ...

By: Aditi Khurana , 2 days ago

Posted in: Regulatory Open Forum

Join us for the SF chapter webinar on 4th April, Tuesday from 12-1pm PT regarding Clinical Trial Data Privacy and Protection. You can register at this link: San Francisco Chapter Event: Clinical Trial Data Privacy and Protection- Fundamentals | RAPS ...

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