Remi and COFEPRIS: what it requires from a health startup and why I'm launching in two stages

To sell health products in Mexico, COFEPRIS requires a physical location, an operating notice, a health compliance officer and sanitary registration for everything you sell, even if you're an app. That's why Remi is launching in two stages: first with products that are already registered, then with our own brand.

Remi is a monthly membership for people with diabetes, high blood pressure or weight issues: diagnosis, in-house doctors, medications delivered to your door and connected devices.

On October 13 I sat down with a lawyer and came out with a list of legal to-dos. I wrote about it in another post. This is part two. More changed than I expected.

100 hours over 7 months

On October 19 the firm's proposal came in: 100 hours of work spread over 7 months.

A hundred hours fits in a month. I told them I needed everything done in 1 month. They said they didn't have the time.

Still, their proposal was useful. It made clear what we needed. I took that list and looked for someone else. On Wednesday the 21st I had the call.

They weren't lawyers, and that's what helped

The call was with a regulatory consultancy. I walked them through all of Remi: the doctor who diagnoses at home, the e-prescription, the monthly medication refills, the devices connected to the platform and the pharmacy with no counter.

A few minutes in, they said something that reframed everything for me: what I need is more regulatory than legal.

They specialize in COFEPRIS filings. Incorporation and contracts are for lawyers and notaries. The rest is handled by pharmaceutical chemists.

For weeks I'd been calling all of it "the legal stuff." It was two different things, with different people.

What COFEPRIS requires even if you're an app

Here's the list that came out of a 40-minute call:

• A physical location. Even if everything is sold through the platform, products are stored in a facility, under the conditions each one requires. Some medications need a cold chain.
• An operating notice for that facility.
• A health compliance officer. A pharmaceutical chemist or physician who answers for the company before COFEPRIS. If you import a batch, they release it. If a customer asks for a certificate of analysis, they sign it. You can hire one or contract one out.
• A quality management system and traceability for every product.
• Clinical records that meet the official standard, even if the consultation is over video.
• Mexican sanitary registration for everything you sell, even if it already has FDA or other certification.

And one I hadn't had on my radar: if software helps with diagnosis, it may be considered a medical device. It needs authorization too.

The device problem

This was the big one.

My plan was for everything to carry the Remi brand: medications made by a lab, and glucose meters, blood pressure monitors and scales manufactured in China with our logo.

Those devices have their certifications, but not from COFEPRIS. To enter and be distributed in Mexico, they need Mexican sanitary registration. And registering a device can take up to a year. There's no legal way to speed it up.

If I wait for our own brand, Remi opens in a year.

The decision: launch in two stages

Stage 1. Remi starts with an operating notice for retail sale of health supplies: a logistics center closed to the public. We buy generics and third-party products that are already registered in Mexico. We don't depend on any year-long filing.

Stage 2. Wholesale distribution with our own sanitary registrations: medications and devices under the Remi brand.

The idea is to launch with stage 1 first and build our own brand in parallel. That's what I told them, and I asked them to move fast.

For the patient, little changes. What matters to them is that the doctor diagnoses them, their medication arrives every month and someone follows up. The box saying Remi can wait.

The team

The next day I talked to an IP and tech law firm that also knows COFEPRIS. I had both proposals and decided:

• The law firm handles the legal side: incorporation, contracts, privacy notice and terms.
• The consultancy handles the regulatory side with COFEPRIS.

What's next

• In the next few days I have a call with the firm and the consultancy together, so they work from the same plan.
• The short- and long-term regulatory plan.
• Find the health compliance officer.
• Decide the type of company and sign the articles of incorporation.

What I'm taking away

Asking for 1 month when I was offered 7 didn't get me a faster lawyer. It got me the right people, because half of what I needed wasn't lawyer work.

If you're building something in health in Mexico, separate legal from regulatory early. They're two lists, with different people and timelines. And find out which filing takes a year before you design your product around it.