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Newsletter Nº 4 ·
Remi is launching without its own brand
Hey, Registering a medical device in Mexico can take 1 year. My goal for launching Remi is 2 months. Here's how I'm solving it.
What happened this week
- I picked Remi's team: a law firm and a regulatory consultant for COFEPRIS, Mexico's health regulator.
- I filed Remi's trademark applications with IMPI, Mexico's trademark office.
- All three devices now connect to the app.
- I changed the launch plan.
The lesson: legal isn't regulatory
For weeks I called all of it "legal."
It was two things:
- Legal: incorporating the company and the contracts. Lawyers.
- Regulatory: everything COFEPRIS asks for. Pharmaceutical chemists.
What COFEPRIS requires, even if you're an app
- A physical place for the products
- A health officer
- A Mexican health registration, even if you already have FDA
And one surprise: software that helps diagnose can count as a medical device.
The new plan: two stages
Stage 1: launch with third-party products already registered in Mexico.
Stage 2: the Remi brand, with its own registrations.
I'm not waiting a year to start.
What's next
Incorporate Remi and get stage 1 ready.
On Thursday I'm publishing the full story.
Read this week
Remi's three devices now connect to the app
Until next Tuesday,
Carlos
CG
CarlosHit reply on the email: I read every one.
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