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RE: Derivation of product requirements from regulatory information/standards - Best practice?

Posted by: Edward Ball, 34 minutes ago

Discussion

Found in: Regulatory Open Forum Discussions

To add an extra dimension on to the great responses from Anne and Ed; your teams need to know what they are looking for. Requirements from regulations are more likely to be very high level in terms of read more
RE: Procedure Pack (PP). Article 22 & Article 16(2) with a medicinal product in the PP.

Posted by: Ronald Boumans, 8 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Articles 16 and 22 only apply to medical devices. Any change in the packaging or user information of the medicinal product, must be seen within the legislation for medicinal products. Obviously, the intended read more
RE: Equivalence by testing

Posted by: Stephanie Grassmann, 10 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Dear Anon MDR Art 61(5) requirements are independent of risk classification. "5. A manufacturer of a device demonstrated to be equivalent to an already marketed device not manufactured by him, may read more
RE: China registration testing samples

Posted by: Jennie Yang, 18 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Hi, Anon, Regarding the marketing authorization of drug product in China, usually NIFDC will only request for the sample testing of DP, otherwise the manufacturer also want to market the drug substance read more
RE: 21 CFR reference on compendial method replacements

Posted by: Raushan Blake, 23 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

The requirement you're referring to is outlined in 21 CFR 211.194, which states that if a compendial method is not used, the method chosen should be validated and documented. Additionally, it mandates read more

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Authenticity Issues Found in Clinical Trial Audit

By: Grace Fu , yesterday

Posted in: Regulatory Open Forum

NMPA is paying more and more attention to clinical trial authenticity audit in IVD as well. Just want to share critical guidelines so that you are aware of what to follow and how to stay compliant for your valuable clinical trial results and efforts. ...
ICH Q2(R2)/M14 expectations

By: Anonymous Member , 2 days ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Dear all, Q2(R2) states that "Accuracy should be reported as the mean percent recovery of a known added amount of analyte in the sample or as the difference between the mean and the ...
Bill 96 and Quebec's language law

By: Lucy Robertshaw , 2 days ago

Posted in: Regulatory Open Forum

Hi, We have been made aware of the Bill 96 and Quebec's language law, we sell class 1 medical devices in North America and we are just wondering if anyone can give me some advice on what documents need to be in French? Many thanks Lucy ------------------------------ ...
Impact of PCR instruments and software updates on a ...

By: Susan (Yuan) Zhang , 2 days ago

Posted in: Regulatory Open Forum

Dear the RAPS community, Our company has developed an IVD product that uses RT-qPCR method for cancer diagnosis. This product has been validated on a number of PCR platforms, each platfoms has its own cut-off value. However, due to updates of PCR platforms ...
Medical devices export for Vietnam market: practices, ...

By: Anonymous Member , 2 days ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous What exactly needs to be done to export and have approved medical devices in Vietnam? What are the practices, rules and regulations to achieve that? Can you elaborate and provide precise ...