The Thai Food and Drug Administration (FDA) has recently updated its regulatory framework, introducing changes designed to streamline the process for device registration in Thailand. These changes, which take effect immediately following their publication ...

Hello Forum, Would anyone be able to recommend a test method to show that a material has antimicrobial properties? Canadian Natural Health Products (NHP) GMP guidance includes an exemption to microbial contaminant testing if the manufacturer is able ...

This message was posted by a user wishing to remain anonymous Hi there, I'm wondering if anyone knows what's meant by a 'Certificate of Registration' for Class I devices under EU MDR? I have a Class I device registered with the Swedish CA and am aiming ...

Hi, We are looking at making drug product submissions in Brazil. It seems the importation requirements are quite stringent. Could someone share regulatory requirements for importation into Brazil? Maybe a checklist? Or point out to guidance documents. ...

Hello, If there is an old product which does not have all the Modules and only Module 1 is present in the dossier, which is possible for products from 60's or 70's. How do we assess a change then ? Changes made in manufacturing now would require ...