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AIA trilogue

Posted by: Xavier Canals-Riera, 3 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Dear all Last night the trilogue arrives to a consensus for the Artificial Intelligence Act Do you know how the new AIA text deal with the overlap with medical AI software to which MDR and IVDR medical read more
RE: Company Name Change affect on UDI

Posted by: Anne LeBlanc, 5 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Hello Anon If it's still the same company, then the UDI can generally stay the same. You'll need to get the name and/or address updated in the UDI database(s), registration(s), and UDI issuing agency. read more
RE: GUDID Private Label confidentiality

Posted by: Anne LeBlanc, 5 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Hello Tim If they have asked you to label the device with their name and not yours, to maintain confidentiality, then they should also have their company name as the labeler in GUDID. The UDIs themselves read more
RE: EU MDR Pediatric Usage Question

Posted by: Anne LeBlanc, 6 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Hello Shikha In the US, probably not. See the guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Device". ------------------------------ Anne LeBlanc United States --------- read more
RE: Australian Sunscreen claim test requirements

Posted by: Anne LeBlanc, 6 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Hi Terry The Australian sunscreen standard 2604 contains top-level requirements and points to several ISO standards for testing requirements, including 24443 and 24444. The "Australian regulatory guidelines read more

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AIA trilogue

By: Xavier Canals-Riera , 3 hours ago

Posted in: Regulatory Open Forum

Dear all Last night the trilogue arrives to a consensus for the Artificial Intelligence Act Do you know how the new AIA text deal with the overlap with medical AI software to which MDR and IVDR medical device regulations apply? Best regards ...
AIA trilogue aproves AIA

By: Xavier Canals-Riera , 19 hours ago

Posted in: Spain Local Networking Group

https://www.tecno-med.es/aprobada-la-aia-artificial-intelligence-act-en-el-trilogo-bajo-la-presidencia-espanola-representada-por-carmeartigas-enhorabuena/ Tecno-med Aprobada la #AIA Artificial Intelligence Act ...
China NMPA has released Medical Device Clinical Trial ...

By: Grace Fu , yesterday

Posted in: Regulatory Open Forum

On November 28, 2023, NMPA released the Medical Device Clinical Trial Inspection Points and Judgment Principles (Draft) asking for feedback. The guideline aims to enhance the quality of medical device clinical trial inspections, establish uniform inspection ...
How much does your senior management recognize reg ...

By: Ryan Connors , yesterday

Posted in: Regulatory Open Forum

In the RAPS 2022 Global Compensation and Scope of Practice Report , 72 % of respondents said senior management and executives are very aware or somewhat aware of the regulatory work they perform. How does that compare with your ...
SPF cream : USA-SWITZERLAND

By: Anonymous Member , yesterday

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Hi I have a question for the community. A person asked me this question, and I could not answer. If a USA ( with OTC monograph license) company wants to produce SPF skin cream in Switzerland ...