How to obtain medical device approval in Mexico
During this video you will learn:
- Overview of the regulatory process in Mexico
- Classification of medical devices by COFEPRIS
- Preparation of the registration dossier
- Special status for US and Canadian companies
- Device testing requirements
- Appointing a Mexico Registration Holder
- Device labeling requirements
- Letter of representation for appointed distributors
- How long it takes to register a medical device, and how much it costs
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