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​ Hi Julia, I submit Medical Device licence applications all the time to Health Canada. Both formats are accepted currently by HC for Class III and IV submissions. Class II and Private Label licence applications need to be in the TOC format. You are correct that the HC format is much less onerous and I still prefer to use this format. I do know ...

Dear Members, We are developing a Fixed-Dose Combination (FDC) drug which includes two API. As per literature data, the Maximum daily dose (MDD) of one API is 300 mg and for other API Maximum daily dose is 3 mg. As per ICH Q3B,  Identification threshold for the API with MDD of 3 mg  is 0.5%   (1 mg - 10 mg) & Identification threshold for the ...

True ------------------------------ Kim Young Director Global Regulatory Intelligence Deeside United Kingdom ------------------------------

Hello Anon, No there is no "pre-inspection" for movement of manufacturing site for a Class II device.  When a Medical Device Manufacturer registers their establishment with the US FDA, once on this database they are subject to an inspection, at any time, by the FDA - for any class of device.  When you change the manufacturing site and you are the legal ...

Hi RAPS  IVD product -   classification .MDR 2017/746  I would like to ask you for feedback if our  classification is correct and the product falls into class A acc. to Annex VIII -IVDR 2017/746 Here is define intended purpose for  both IVD producs: 1)Antimycotic susceptibility discs are used for  the determination of the susceptibility ...