Healthcare & Industrial Setup
Before you spend a cent on construction, know exactly what ANVISA and the health authority will require.
What Healthcare & Industrial Setup is
Healthcare & Industrial Setup is ElevenGene Labs’ service for anyone building, refurbishing or bringing into compliance a healthcare facility or a medical device manufacturing site in Brazil. We are not an architecture practice and not a builder — we are the technical and regulatory partner that defines what the project must contain to be approved, coordinates the licensed professionals and delivers the documentation ready for licensing. You avoid the most expensive mistake in the sector: finding the non-conformity after the concrete has set.
Construction
You are building a clinic and discovered the design does not meet RDC 50/2002 — after construction had already started.
Inspection
You received a notice of violation from the health authority for operating without a current sanitary licence.
Requirements
You want to open a clinical laboratory and do not know the minimum requirements for area, workflow and technical officer.
Feasibility
You are raising investment for a clinic or hospital and need to prove the project is regulatorily viable.
Do any of these sound familiar?
“Building without knowing the regulation is not courage — it is the most expensive route to the same destination. One non-conformity found at the sanitary inspection can cost more than the entire preventive consultancy.”
What We Do
| ✓ Full regulatory diagnosis before any construction decision is made ✓ Technical brief for the architect carrying every requirement of the standard ✓ Regulatory review of the design at each version delivered ✓ Activity Memorandum prepared for sanitary licensing ✓ Coordination with the local health authority, including pre-consultation ✓ Complete dossier structured for the sanitary licence ✓ AFE petition filed with ANVISA where applicable ✓ Preparation for and attendance at the sanitary inspection ✓ Technical support for formal requirements from the licensing bodies |
What you receive
| ✓ Regulatory Feasibility Report with every gap mapped ✓ A design that reaches approval with no surprises at inspection ✓ Activity Memorandum ready to file with the health authority ✓ Approved needs programme, where applicable ✓ Regulatory Conformity Opinion on the final design ✓ Complete dossier organised and ready for inspection ✓ AFE petition structured and ready for submission, where applicable ✓ CNES registration completed, where applicable ✓ The minimum set of SOPs required for regular operation ✓ Healthcare waste management plan — structure and guidance ✓ Support for formal requirements for 30 days after the inspection |
Facilities we serve
| Type of facility | Main standard | Licensing body |
|---|---|---|
| Medical or dental clinic | RDC 50/2002 | ANVISA + municipal/state health authority |
| Clinical analysis laboratory | RDC 978/2025 | ANVISA + health authority + CFBio/CRF |
| Small hospital or day hospital | RDC 50/2002 + RDC 36/2013 | ANVISA + health authority + CNES/Ministry of Health |
| Compounding pharmacy | RDC 67/2007 + RDC 87/2008 | ANVISA + health authority + CRF |
| Medical device manufacturing plant | RDC 665/2022 (GMP) | ANVISA — manufacturer AFE |
| Molecular diagnostics laboratory | RDC 978/2025 | ANVISA + health authority + CFBio |
| Diagnostic imaging centre | RDC 50/2002 + RDC 611/2022 | ANVISA + health authority + CNEN |
Duration 8–20 weeks, depending on the project · Format technical and regulatory consulting in three modular phases — P1 regulatory feasibility · P2 technical and regulatory design · P3 licensing and commissioning · phases can be contracted separately
ElevenGene Labs designed and built its own molecular diagnostics operation in Botucatu, going through exactly the process we now coordinate for our clients. We do not teach the theory: we apply the method that already worked for us.
