Registration Holder in Mexico
The Passarini Regulatory Affairs has a differential service in its portfolio, that is the Hosting Service, and if perhaps your company doesn’t have a sell’s office or a physical address in Mexico, is necessary to name a Host as your nominee in the country, and for that you may count with our support, once we have such representation.
The Registration Host is responsible to coordinate, submit and maintain your medical device record with COFEPRIS, the internal division of the Health Ministry of Mexico in charge to supervise the devices.
Most companies who entry in the Mexican market are trusting its devices’ records and approval only to the distributors. Although it is convenient, the problem to depend on a distributor to obtain the product’s approval is that they control the registration. This hamper eventual changes of distributors, because the new distributor would need the permission of the current to import your devices, or would need to register your products once more.
The Passarini Regulatory Affairs is an independent consulting company and highly experienced in regulatory affairs about devices in Mexico.
If you are interest in work with our company, you can appoint or change your distributors as your needs. Below you will find good reasons to work with us:
We count with high qualified professionals, trained to provide a complete assistance in the acquisition of the Mexican approval from the COFEPRIS;
We are one of the most respected consulting companies and records Host of medical products and IVD in Mexico.
