A few weeks before the first case, a sponsor almost always asks me the same thing: our implanting physician from the US wants to proctor the first cases, and our field clinical engineer will be in the room. Do they need anything from the local authorities? The answer is yes for the physician in most of Latin America. For the engineer it depends on what he or she touches.
I am Julio Martinez-Clark, CEO of bioaccess®. This page sets out what the public rules say in Colombia, Brazil and Panama about foreign physicians taking part in procedures, how that interacts with 21 CFR Part 812, and how I plan the paperwork so the first case doesn’t slip. It sits next to our early feasibility studies page, the Panama FIH guide and the clinical trial insurance guide. This is operator guidance, not legal advice. Confirm the current requirements with the site and the local medical college before you book flights.
One-sentence answer
A foreign physician who performs or scrubs into a procedure in a Latin American trial needs a temporary authorization from the local medical regulator, requested by the host institution, with home-country licenses, a named local team that stays responsible for the patient, and in Colombia a liability policy and a declared purpose that is not promotional. A sponsor engineer who stays off the sterile field and never handles the device while it is in the patient is usually treated as technical support, not as practicing medicine.
Why this is a regulatory question, not a travel question
Medicine is a licensed profession in every country in the region. A business visa lets someone enter the country. It does not let them operate. When a foreign physician treats a study subject without the local authorization, the problem lands on the site, on the investigator who allowed it and on the data. An ethics committee or a monitor who finds an unlicensed operator in the procedure notes will ask questions you don’t want in an FDA submission.
Colombia: permiso transitorio
Colombia has the most detailed public framework I know of in the region.
- Legal basis. Ley 1164 de 2007, Art. 18, parágrafo 3, grants foreign health personnel who come in scientific missions or to provide services of a humanitarian, social or research character a temporary permit for the length of the mission, which must not exceed six months. Extensions are only for exceptional, documented cases. Parágrafo 3 says the permit is issued by the Ministry of Health directly or through the professional colleges with delegated public functions, and Art. 10(c) lists issuing it among those colleges’ functions.
- Procedure. Decreto 780 de 2016, Arts. 2.7.2.1.3.1 to 2.7.2.1.3.3 (which took over Arts. 21 to 23 of Decreto 4192 de 2010), set out the request. The Ministry’s Circular Externa 024 of 6 July 2018 explains how the colleges apply it. A denial by a college can be appealed to the Ministry.
- The commercial exclusion. Circular 024 says no permit will be granted when the purpose, the activities or one of the objectives of the mission is the promotion, advertising, sponsorship or commercialization of services, procedures, medicines, devices or health technologies. A clinical investigation is research, but write the request so that the purpose is plainly the protocol, not training for a commercial launch.
- Payment. The circular says paying the foreign professional’s fees or expenses does not by itself make the mission for-profit. If a Colombian institution pays the visiting physician, the request has to say so and explain why personnel licensed in Colombia were not used. No payment may come from the patients.
- Host IPS. The mission must be supported by a health provider (IPS). The request names the IPS and the services used, with a letter from its legal representative accepting responsibility for the consequences for patients. The college checks those services are enabled in the REPS registry.
- Insurance. Once the permit is granted, the responsible organization must take out a collective civil liability policy of no less than 250 monthly minimum wages, covering the mission plus 12 months, with an insurer supervised by the Superintendencia Financiera. The territorial health authority asks for it before the mission starts. This is separate from the study’s clinical trial insurance.
Brazil: autorização especial from the CRM
In Brazil the route runs through the regional medical council (CRM) under Resolução CFM nº 1.494/1998, which covers medical acts performed as didactic demonstrations by foreign physicians invited by universities, official bodies, associations and scientific institutions. Art. 1 asks the inviting institution to give the CRM:
- the names of the invited medical team;
- proof that they entered Brazil lawfully;
- original documents from their home countries proving they are licensed;
- a program, approved by the sponsoring institution, with the place of the procedures, proof of technical capacity, the local medical team and each member’s level of responsibility, patient selection criteria without discrimination, the immediate and late post-operative plan including complications, the patient’s informed consent and a favorable opinion from the institution’s medical ethics committee.
Art. 2 makes the institution’s technical director responsible for compliance. Art. 3 forbids charging any payment for the medical acts performed. The CFM’s service page asks for the request at least 30 days in advance, with a responsibility statement signed by the institution’s technical director. I plan for that 30-day window as a minimum, on top of the CEP and ANVISA approvals the trial already needs.
Panama: reserved profession, case-by-case authorization
MINSA states publicly that medicine in Panama is a profession reserved for nationals. Ley 69 de 2013 lets MINSA and the Caja de Seguro Social hire foreign health professionals temporarily, but it is a public-sector hiring route with exams and a temporary registry. It is not designed for a visiting proctor.
For a visiting physician, Panama’s procedure guides list a MINSA procedure, handled by the Dirección General de Salud, that authorizes foreign physicians to take part in demonstrations and surgical procedures together with Panamanian physicians in public and private hospitals. The request is a formal letter from the hospital or medical association, with the invited physicians’ licenses and certificates of good standing. Read the word “together”: the Panamanian investigator stays in the case.
Other countries
Each country has its own route, usually through the medical college or the health ministry, and the requirements change. Don’t assume a rule from one country carries over to the next. Ask the site’s medical director early which authority grants the permit, who files it and how long it takes. If nobody at the site has done it before, that is a feasibility finding.
Where 21 CFR Part 812 fits
- Who is an investigator. 21 CFR 812.3(i) defines the investigator as the person under whose immediate direction the device is used on a subject. A proctor who performs part of the procedure is doing investigator work. List the proctor on the site’s delegation log with the tasks delegated, and make sure the local principal investigator stays responsible.
- Qualified investigators. 812.43(a) requires the sponsor to select investigators qualified by training and experience. The local authorization is part of the evidence that the person was qualified to act in that country.
- Data you want FDA to accept. If the study will support an IDE or a marketing submission, 812.28(b) asks for the names and qualifications of the investigators. A case run by someone without local authorization is a weak point in that file.
- No promotion. 812.7(a) prohibits promoting an investigational device. It lines up with Colombia’s commercial exclusion. Keep proctoring framed as protocol support.
Field clinical engineers
Engineers set up consoles, check software versions, confirm device sizes and answer technical questions. That is normal in early feasibility work. Here is the line I hold:
- Off the sterile field, no hands on the patient and no hands on the device while it is in the patient.
- Name the role in the protocol or the monitoring plan, and the tasks on the delegation log.
- Hospital access, confidentiality and any badge or induction the hospital requires are agreed with the site before the visit.
- If the engineer has to do more than that, treat it as a clinical role and run it through the authorization route above, or train a local team member to do it.
Mistakes I see
- Booking the first case before the permit is granted, then pushing the date when the college asks for an apostilled document.
- A request that reads like a product launch or a training tour, which in Colombia is a reason to refuse it.
- No local physician named as responsible for post-operative care and complications.
- Assuming the clinical trial insurance policy covers the foreign physician. In Colombia the mission needs its own civil liability policy.
- No delegation-log entry for the proctor, which shows up at the first monitoring visit.
How bioaccess® runs this
bioaccess® plans the proctor and engineer plan during site selection, works with the site’s medical director to prepare the authorization request, collects and apostilles the licenses and certificates, and lines up the permit date with ethics and regulatory approvals and device import. Study scope and pricing are set at proposal. Start on our early feasibility studies page, see market access for the country pages, or book a call.
Operator checklist
- At feasibility, ask the site which authority grants the visiting-physician permit and how long it takes.
- Collect home-country licenses, certificates of good standing and diplomas, apostilled, at least 6 weeks before the first case.
- Write the request around the protocol: purpose, dates, procedures, patients, local team.
- Colombia: name the IPS, get its legal representative’s letter, declare any payment and buy the 250-minimum-wage liability policy for the mission plus 12 months.
- Brazil: file with the CRM at least 30 days ahead with the CFM 1.494/1998 program and the ethics committee opinion.
- Panama: the hospital files the MINSA request; the Panamanian investigator stays in the case.
- Put the proctor and the engineer on the delegation log with defined tasks.
- Keep the permit in the investigator site file, ready for monitoring and for an FDA 812.28 package.