POST-MARKET SURVEILLANCE

Report an adverse event: tecnovigilancia@insumosparasalud.com

Report an adverse event: tecnovigilancia@insumosparasalud.com

For IPS, pre-market data typically reflect short-term periods of observation or use and may not reflect potential incidents or adverse information that would arise over longer periods, such as the post-market phase. Given the considerations set above, our Post-Market Surveillance Unit:

  • Complies with the official norm of the Ministry of Health NOM-240-SSA1-2012, also known as Installation & Operation of Post-Market Surveillance (Tecnovigilancia).

  • Works in tandem with local distributors to gather information on the products sold throughout the life of the registration.

  • Prepares the 5-year report (Informe Quinquenal de Tecnovigilancia) requisite for registration renewal.

  • Implements procedures in case of adverse events that could lead to inquiries, serious injuries, or death.

    • Proactive surveillance for the products that we represent (host)

    • PMS reports

    • PMS Units & SOPs

    • PMS Trainings

Hosting Products registered by a different company

IPS is happy to cooperate if a different company prepares your COFEPRIS application; however, we must do our due diligence by ensuring the product complies with the highest safety & efficacy standards. Until today, none of the products we host have faced any adverse events.

Transferring products to IPS

Transferring your products to another registration holder, such as IPS, requires the cooperation of the current holder. The transfer or rights is done before a Notary Public.

important to keep in mind

We make sure your product complies with post-market regulations in Mexico.

Strengthen you sales strategy by having various distributors.

No need for exclusivity. Distributors will have less leverage on you.

Remove distributors from the registration if they don’t prove to be the right partner.

Ask questions, we provide ongoing answers.

Receive a timely notification when it’s time to renew the registration.

Resources

NOM-240-SSA1-2012

Download the current legislation (Spanish version)

OPENING AN OFFICE IN MEXICO?

We transfer the registrations to you - hassle-free. In addition, we can put you in touch with a law firm that can help you get up and running in no time.