RDC 978/2025: what Brazil clinical laboratories must change

Anyone opening a laboratory, building a network of collection points, offering rapid tests in a pharmacy or regularising a unit that has been running for years has to start from one regulation. For Brazil clinical laboratories, that regulation is Anvisa’s RDC 978/2025, which sets the technical and sanitary requirements for every service that performs clinical laboratory testing, public or private. The trouble is that plenty of floor plans, design briefs and SOPs still cite rules that are no longer in force. This article sets out what has changed and what it means for anyone designing a facility now.

The timeline: 302, 786 and 978

For almost two decades, a clinical laboratory in Brazil meant RDC 302/2005. It was revoked by RDC 786/2023, which took effect on 1 August 2023. In June 2025, RDC 786 was itself revoked by RDC 978/2025 (art. 193).

Regulation	Status	What to do with it
RDC 302/2005	Revoked by RDC 786/2023	Remove it from designs, manuals and contracts
RDC 786/2023	Revoked by RDC 978/2025	Remove it; check what was kept and what changed
RDC 978/2025	In force	The single reference for services performing clinical laboratory testing

RDC 978 is dated 6 June 2025 and was published in the Official Gazette on 10 June 2025. A common mistake is to say it “comes into force in 90 days”. It does not: art. 194 states that it applies from the date of publication, and art. 191 gives services 90 days from publication to comply. That period ended in September 2025. Anyone still working with documentation based on RDC 302 or RDC 786 has been out of compliance since then.

Service types, and why classification comes before the floor plan

Art. 7 classifies services as Type I, Type II, Type III and Mobile (itinerant) Testing Service. The classification is not a label: it determines what the service may do, what structure it needs and whom it must be linked to. Getting the type wrong at the start usually means redoing the design later.

Type	Who it covers	Main limits
Type I	Pharmacy or stand-alone practice (art. 8)	Only capillary puncture, oral cavity, nasopharyngeal or oropharyngeal samples; every phase on site, including internal and external quality control; no storage or transport of biological material; no in-house methods; no equipment that depends on reagent water produced on site (art. 10)
Type II	Collection point (art. 19); a stand-alone practice may also qualify (art. 20)	A collection point is linked, by ownership or contract, to a single Type III service (art. 5, XXXI)
Type III	Clinical laboratory and anatomical pathology laboratory (art. 33)	The only type allowed to develop in-house methods (art. 157) and to run a mobile service (art. 43)

For a pharmacy that wants to offer rapid tests, the art. 10 requirements are the first screen. If the plan includes venous collection, sending samples elsewhere or an analyser that needs purified water produced on site, Type I no longer fits. For a network of collection points, the link to a single Type III service must be settled before each unit is licensed.

What changes for anyone designing the facility

Physical infrastructure and architectural design

Art. 40 requires Type III infrastructure to comply with RDC 50/2002 and its updates. RDC 50 is the technical regulation for planning, programming, preparing and assessing physical designs for healthcare facilities, and it remains in force, as amended by RDCs 307/2002 and 189/2003. It is where the architect finds the rooms, dimensions and flows.

The sole paragraph of art. 191 explains when RDC 978’s infrastructure items apply: to refurbishments or extensions of existing services, to new builds, and to adapting premises that were not intended for healthcare or whose use has changed in one or more rooms. In practice, anyone refurbishing or moving has to design to the current rule, not to the one in force when the unit was first licensed.

Sanitary licence and technical lead

Every service performing clinical laboratory testing needs an operating licence or equivalent issued by the local health authority, stating the testing activities (art. 73). For Type I, the licence must state both the testing activities and the pharmacy or practice activities (art. 63). Art. 75 requires a legally qualified technical lead (responsável técnico) and, in its sole paragraph, a qualified professional to stand in when the lead is unavailable. It pays to name the deputy from day one.

Distribution Centre

The regulation devotes a chapter to the Distribution Centre, the support facility that stores, packs and transports biological material (arts. 144 to 153). For networks with centralised logistics, the points that affect the design are straightforward:

• its own licence, expressly stating the activities carried out (art. 149);
• a legally qualified technical lead (art. 146);
• minimum structure: a room for receiving, sorting and temporary holding of at least 3.0 m², with a bench and hand basin; changing rooms and toilets; a sluice room; a cleaning store; sharps and waste disposal; an area for equipment and materials; an area for receiving and dispatching transport containers (art. 151);
• temperature and humidity records (art. 151, sole paragraph);
• a ban on opening the primary packaging, on performing analytical and post-analytical phases (art. 148) and on receiving material from a mobile service (art. 145).

External quality assessment and proficiency testing

Every service must take part in external quality assessment programmes, individually, on every piece of equipment in use and for every analyte (arts. 185 to 188). Quality control records must include the external quality assessment performance report issued by the proficiency testing provider at least once a year (art. 176, V). For tests with no programme available, the service must use alternative ways of assessing accuracy described in the scientific literature (art. 189).

Two details matter for networks. Individual participation means each service needs its own enrolment. And a Type III laboratory that outsources tests must assess its reference laboratory every year, checking its sanitary compliance and its proficiency testing results for the contracted tests (art. 38).

In-house methods (LDTs): Type III only, with documented validation

For molecular biology laboratories, this is the chapter that matters most. RDC 978 defines an in-house method (metodologia própria) as an analytical method, reagents or devices developed, produced and validated by a Type III service for use in its own setting (art. 5, XXIX). The core rules:

1. Type III only may develop and use in-house methods (art. 157), and every phase must take place at the service that developed the method (art. 162).
2. Minimum documentation: process steps, traceability of products and inputs, specification and approval of inputs, reagents and equipment, validation of steps and procedures, and determination of sensitivity and specificity (art. 158).
3. RUO, ASR and IUO inputs may form part of the procedure (art. 158, sole paragraph), but their instructions for use cannot be the sole basis for validation (art. 163, § 2).
4. A validation report covering procedures, materials, analytical parameters, acceptance criteria and results, in enough detail to allow the work to be reproduced (art. 164).
5. The test report must state which results were obtained with an in-house method (art. 159).
6. It is forbidden to sell, pass on, donate or supply for use any reagent or product derived from the in-house method (art. 160). The exception is supplying pre-analytical reagents and materials to the linked Type II service. Scientific know-how, on the other hand, may be transferred (art. 161).

Art. 160 is where many business plans run aground. A laboratory that has developed a good in-house assay cannot sell it as a kit to other laboratories. For that, the product must follow the in vitro diagnostic device route, with notification or registration at Anvisa according to the risk class set by RDC 830/2023.

A checklist before you call the architect

In our laboratory and in the projects we support, we often see licensing delays that trace back to decisions made before the first drawing. Before commissioning a design, it is worth having written answers to these questions:

• What type is each unit (I, II, III, mobile), and which tests and collections will it perform?
• Is each collection point linked to a single Type III service?
• Will there be an in-house or contracted Distribution Centre? Does it have a licence and a technical lead?
• Who is the technical lead of each unit, and who is the deputy?
• Will there be in-house methods? Is there a validation plan and a report in the format of art. 164?
• Which tests have a proficiency testing programme available, and what is the alternative for those that do not?
• Was the physical design prepared to RDC 50/2002 and its updates, and to the local health authority’s requirements?

From regulation to licence

RDC 978 is not hard to read, but it is easy to apply halfway: the design is architecturally sound and then runs into classification, the Distribution Centre or the in-house method file. What works is defining the sanitary requirements before the drawing and keeping every qualified professional working from the same list.

That is the role of Healthcare Industrial Setup: we act as a technical and regulatory partner to build, refurbish or regularise healthcare facilities. We define what the design needs in order to be approved, coordinate the qualified professionals and deliver the licensing documents. We are not an architecture practice or a building contractor. If your laboratory also develops in-house methods and needs to close out validation, Method Dev Sprint covers that part. To discuss your case, use our contact page.

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Sources

• Anvisa — RDC 978/2025, full text (Anvisalegis) (Portuguese)
• RDC 978/2025 — LegisWeb (Portuguese)
• Fukuma Advogados — New RDC sets technical and sanitary requirements for clinical laboratory testing (Portuguese)
• Anvisa — RDC 50/2002, physical design of healthcare facilities (Anvisalegis) (Portuguese)