If your Class III or Class IV devices are finished at more than one plant, does Brazil want one ANVISA CBPF (Certificado de Boas Práticas de Fabricação) covering the whole network, or a certificate path for each site? That is the question sponsors keep sending me when the supply chain map has two or three manufacturing addresses on it.
I’m Julio Martinez-Clark, CEO of bioaccess®. We help medical device companies through first-in-human studies and market access across Latin America, and Brazil is one of the markets where manufacturing-site planning decides the registration calendar. This article walks through how ANVISA treats multi-site manufacturing for CBPF, what RDC 687/2022 Art. 3 actually covers, and how I’d brief a US- or China-based medtech manufacturer with two Class III plants.
The short answer
ANVISA issues the CBPF per manufacturing unit (unidade fabril). The gov.br service page for obtaining CBPF of medical devices states that the certificate is issued per unidade fabril and covers the production lines and/or risk classes for which that establishment was inspected. It is not a company-wide umbrella that automatically blankets every plant you own.
For Class III and Class IV devices, RDC 687/2022 Art. 3 sets which manufacturing units are certification objects. If two plants each finish a Class III/IV product (or each meet another Art. 3 trigger), plan on a CBPF path for each of those units — not one certificate for the whole network by default. Sites that only perform excluded steps (design, distribution, sterilization, packaging, labelling, with the sterile-barrier packaging nuance in Art. 3 §1) may fall outside the certification object. That call is regulatory, not commercial convenience.
What “per unidade fabril” means in practice
ANVISA’s public service page, Obter Certificação de Boas Práticas de Fabricação (CBPF) de Dispositivos Médicos, defines the certificate as the document that attests a given establishment complies with good manufacturing practices. The key sentence for multi-site planning is that the certificate is issued per unidade fabril, covering the production lines and/or risk classes inspected at that establishment.
RDC 687/2022 (English PDF available from ANVISA) defines a manufacturing unit as the site where one or more manufacturing stages take place. That site can be the legal manufacturer, a contract manufacturer, or the original product manufacturer. Two physical plants are two unidades fabris. A single legal entity with plants in two cities still has two units for CBPF purposes.
So when a sponsor asks “can we put both plants on one CBPF?”, the grounded answer is: ANVISA certifies the unit that was inspected, for the lines and classes in that inspection scope. Don’t build a Brazil launch plan on one certificate covering every factory by default.
Which sites actually need CBPF under RDC 687/2022 Art. 3
RDC 687/2022 applies to granting and renewal of CBPF for medical devices. Class III and Class IV manufacturing units that meet any of the Art. 3 conditions are subject to CBPF:
- Final-product manufacturer. A unit that produces a final product on its own behalf or for another company.
- Final release plus a production stage. A unit that performs final release of the final product and carries out at least one production stage, excluding design, distribution, sterilization, packaging, and labelling. Sterile-barrier packaging for sterile products is treated as a certifiable production stage under Art. 3 §1. Certain IVD strip steps (impregnation, lamination, or cutting of immunochromatography strips) are also brought in under §2.
- SaMD manufacturing unit. A medical software (Software as a Medical Device) manufacturing unit.
That Art. 3 list is the filter. A design-only site, a warehouse that only distributes, a contract sterilizer, or a packaging/labelling house that does not meet the sterile-barrier exception is not automatically a certification object under the plain text of Art. 3. Say that carefully: “not automatically” is not the same as “never relevant to the registration file.” Your Brazilian registration holder still has to map every manufacturing step to the product dossier. The CBPF question and the registration dossier question are related, but they are not identical.
RDC 687/2022 also sits on top of the Class I/II rule from RDC 497/2021: Class I and Class II manufacturers are not CBPF objects under that framework. Multi-site Class I/II networks raise different Brazil planning issues; don’t copy a Class III/IV CBPF calendar onto them.
Two production lines still mean separate CBPF petitions
Even after ANVISA simplified petition subject codes, the two production lines defined in RDC 497/2021 Art. 19 stay separate for CBPF petitions:
- (I) materials and medical-use equipment
- (II) in vitro diagnostic (IVD) products
On 11 February 2026, ANVISA published a clarification that unifying petition subject codes did not remove the need for separate petitions for those two lines. Petitions that mix materials/equipment CBPF requests with IVD CBPF requests in one filing will draw a requirement to align with Art. 19. See ANVISA’s 11 Feb 2026 note.
For a manufacturer that finishes both electromedical equipment and IVDs, that means separate CBPF petition streams even when the subject-code list looks shorter than it used to. Multi-site planning has to multiply by line as well as by unidade fabril.
How I’d brief a multi-plant sponsor
Take a US- or China-based medtech manufacturer with two Class III plants — one that assembles and releases the finished device, and one that only does secondary packaging and labelling. The briefing I give looks like this:
- Map each address to Art. 3. Plant A finishes and releases the product → expect a CBPF path for that unidade fabril. Plant B only packages and labels, with no sterile-barrier system step → it may not be a certification object under Art. 3 II, but document that reading with counsel and your Brazilian holder before you drop it from the plan.
- Do not assume one certificate covers both. ANVISA’s service page is explicit: the certificate is per unidade fabril for the lines/classes inspected there.
- Split petitions by Art. 19 line. If both plants touch materials/equipment products only, you still need the per-unit CBPF logic. If one plant also finishes IVDs, add a separate IVD petition stream.
- Put the inspection calendar on the critical path. The gov.br service page cites an average around 106 calendar days for the service, with a maximum wait framed by RDC 416/2020. Multi-site means multi-inspection risk. Sequence the units that gate the first Brazil SKUs first.
- Keep INMETRO off this same track. Electromedical equipment still has a separate conformity assessment path under INMETRO (and ANATEL where radio modules apply). That is not CBPF. See our note on Brazil INMETRO and ANATEL certification alongside medical device registration. Don’t fold foreign-lab INMETRO detail into the CBPF workstream; they are parallel tracks.
Where this sits in Brazil market access
CBPF for Class III/IV manufacturing units is one gate inside a broader Brazil plan that also includes Cadastro or Registro of the device, the Brazilian Registration Holder (DDR) arrangement, and import authorization. For the country overview, start at our Brazil ANVISA market-access page and the regional hub at bioaccess® market access. If the open question is third-party import authorization rather than manufacturing-site CBPF, see Brazil ANVISA DDR and third-party import authorization.
The sponsor mistake I see most often is treating “we already have ISO 13485 at corporate HQ” as a substitute for ANVISA’s per-unit CBPF. ISO helps the dossier and the inspection conversation. It does not replace a CBPF issued for the unidade fabril that meets Art. 3.
Operator checklist before you file
- List every manufacturing address that appears on the device’s manufacturing flow, including contract manufacturers.
- For each address, write a one-line Art. 3 I / II / III / out-of-scope call, with the sterile-barrier and IVD-strip exceptions noted where relevant.
- Confirm whether each in-scope unit is materials/equipment, IVD, or both (Art. 19 separate petitions).
- Confirm the Brazilian holder and the Solicita petition subject codes you will use after the Feb 2026 unification — same codes across lines, still separate petitions.
- Park INMETRO/ANATEL on a parallel track for electromedical SKUs; do not wait for CBPF to “absorb” conformity assessment.
- Build the Brazil launch date off the slowest in-scope unidade fabril, not the fastest.
Bottom line
For Class III/IV devices finished at two different plants, plan a CBPF path for each manufacturing unit that meets RDC 687/2022 Art. 3. ANVISA’s own service page says the certificate is issued per unidade fabril. Sites limited to excluded steps may sit outside the certification object — confirm that against Art. 3 with your holder before you cut them from the plan. And keep materials/equipment and IVD petitions separate under RDC 497/2021 Art. 19, even after the 2026 subject-code unification.
If you’re mapping a multi-site Brazil CBPF plan and want a second set of eyes on the Art. 3 calls, bioaccess® can walk the manufacturing flow with your team against the current ANVISA rules before you petition in Solicita.