Mandatory MDSAP for international manufacturers operating in Brazil: what Anvisa is preparing and why you should not wait for the rule
Anvisa is studying whether to make MDSAP mandatory for international manufacturers operating in Brazil. The proposal is not yet a rule, and the public consultation is expected by the end of 2026.
Picture the scene. It is Monday morning, the coffee is still hot, and an email arrives from your manufacturing partner abroad with a direct question: "We heard Brazil is going to require MDSAP. Is that true? Are we at risk?"
You know that the product registration depends on the Good Manufacturing Practice Certificate. You also know that losing that certificate means stopping imports, stopping sales and, in the worst case, seeing years of work stalled by a regulatory detail. The answer has to be precise. "I think so" or "I don't think so" will not do.
If that question has already reached you, or you suspect it soon will, this article is for you. We will walk through what Anvisa has already decided, what is still under discussion and what makes sense to do now, based on official sources and without alarmism.
The short answer: MDSAP may become mandatory for international manufacturers that sell medical devices in Brazil, but it is not mandatory yet. Anvisa is halfway there, and the next step, the public consultation, is expected by the end of 2026.
Now, the full answer.
One programme, five countries, a single audit
Before looking at what may change, it is worth understanding what MDSAP is and why it has gained so much ground.
MDSAP, the Medical Device Single Audit Program, was born from a simple idea: if five major regulatory authorities assess practically the same quality requirements, why should a manufacturer go through five different audits?
With MDSAP, the manufacturer hires an auditing organisation recognised by the programme and undergoes a single audit of its quality management system. The result is accepted by the five authorities that make up the programme:
- Brazil, through Anvisa;
- United States, through the FDA;
- Canada, through Health Canada;
- Australia, through the TGA;
- Japan, through the MHLW and the PMDA.
The audit is based on ISO 13485, plus the specific requirements of each country. In practice, that means less factory time spent hosting auditors, less duplicated effort and a common language across markets that, together, account for a large share of global medical device trade.
MDSAP already plays a leading role in Brazil
Here is a point many people overlook: MDSAP is no longer a supporting actor in Brazil. It is already the main route.
To register medical devices in risk classes III and IV, Anvisa requires the manufacturing site to hold a Good Manufacturing Practice Certificate (CBPF). The criteria for granting and renewing this certificate are set out in RDC No. 687/2022.
Today, under Article 8 of that regulation, an international manufacturer can obtain the certificate through three routes:
- An MDSAP audit report, reviewed by Anvisa together with the company's documentation;
- A documentary review with risk assessment, without an on-site inspection;
- An Anvisa inspection at the factory, when the risk assessment calls for it or when there is no audit report.
The MDSAP route already dominates: according to an analysis by the consultancy Emergo by UL, 65% of the Good Manufacturing Practice certificates published by Anvisa are based on MDSAP certificates.
Anvisa has also sent a clear signal of preference. Since 2024, under RDC No. 850/2024, a CBPF granted on the basis of MDSAP has been valid for four years instead of two, provided the MDSAP certification is maintained throughout the period.
In other words, companies in MDSAP already gain time, predictability and fewer renewals. The current discussion is whether this route, today the preferred one, will become the only one.
The timeline: how we got here
The proposal under review is to amend RDC No. 687/2022 to make MDSAP a mandatory requirement for granting and renewing the CBPF of international manufacturers of medical devices, that is, companies with manufacturing sites outside Brazil that register, or want to register, their products here. Factories located in Brazil are not in scope: at the Board meeting that addressed the topic, the rapporteur director clarified that, for national companies, joining MDSAP remains optional.
Here is how the story unfolded.
10 December 2025: the proposal reaches the Collegiate Board
At the 20th Ordinary Public Meeting of the Collegiate Board, rapporteur director Rômison Mota presented the proposal to amend RDC No. 687/2022 and take it straight to public consultation. The central argument, reinforced by Anvisa's president Leandro Safatle, was regulatory equity: Brazilian factories of high-risk products undergo inspection, while foreign manufacturers can obtain the certificate through a documentary review. The idea is that no high-risk medical device should be certified without a level of verification consistent with its potential for harm.
The outcome of the meeting was this: the Board unanimously approved opening the regulatory process and decided, by majority, that a Regulatory Impact Analysis (AIR) must be carried out before the public consultation. The rapporteur and director Daniel Pereira, who argued for going straight to consultation, were outvoted. Among the points the AIR is to assess are the profile of class III and IV products currently certified without inspection, the capacity of auditing organisations to meet demand and the risk of shortages if certification through documentary review ceases to exist. In practice, Anvisa decided to study the matter in depth before proposing a text.
January 2026: the topic enters the Regulatory Agenda
Anvisa's 2026-2027 Regulatory Agenda, approved by Ordinance No. 1,484/2025 and in force since 1 January 2026, includes under item 5.6 the topic "mandatory participation in MDSAP for the certification of international medical device manufacturers". The agenda is the list of topics the agency commits to addressing during the period.
June 2026: the subject reaches Kyoto
At the MDSAP Forum 2026, held in Kyoto, Japan, Anvisa presented updates on the programme in Brazil. According to ABIMED, which attended the event, the agency reported that the Regulatory Impact Analysis is under way and that the public consultation is expected in the last quarter of 2026.
To avoid any doubt: what is already fact and what is not yet
On regulatory matters, a badly told rumour can be costly. That is why we clearly separate the two.
| Point | Status |
|---|---|
| Regulatory process | Open. Approved by the Collegiate Board on 10 December 2025 |
| 2026-2027 Regulatory Agenda | Included, item 5.6 |
| Who is affected | International manufacturers only. Factories in Brazil are not in scope |
| Regulatory Impact Analysis | Under way |
| Public consultation | Not yet open. As of the date of this publication, no act has been published in Brazil's Official Gazette |
| Obligation in force | None. Today, MDSAP remains one route to the CBPF, not the only one |
| Transition period | Not defined. It will only exist after the public consultation, the Collegiate Board's decision and the publication of the revised regulation |
If anyone tells you that "MDSAP is already mandatory in Brazil", that information is wrong. If they say "this will never happen", that is wrong too.
Who should pay attention now
This discussion is not only relevant to manufacturers. It runs through the entire chain.
- International manufacturers of class III and IV medical devices that sell, or plan to sell, in Brazil. They are directly affected, and they are the only target of the proposal.
- Registration holders and importers that represent these manufacturers in the country. The registration is in their name, but it depends on the manufacturer's CBPF. If the certificate falls, the problem reaches them.
- Manufacturers already in MDSAP. For them, the key word is maintenance: the four-year validity of the CBPF only applies while the MDSAP certification remains active.
Why waiting for the regulation is the worst strategy
There is a natural temptation to wait. "When the rule comes out, we will deal with it." The problem is that MDSAP cannot be sorted out in a few weeks.
Joining the programme involves choosing a recognised auditing organisation, adapting the quality management system to the requirements of the five countries, going through the initial audit and addressing any nonconformities. It is a project, not a formality.
Now picture the scenario in which the requirement is approved. Many manufacturers will seek the same service at the same time. Auditing organisations' schedules tighten, qualified professionals are in high demand, and those who left it for later find themselves racing against the clock, with their product registrations at stake.
Those who start early enter this phase calmly, with a diagnosis in hand and decisions already made.
Four steps to start today
- Map your exposure. List the manufacturers and manufacturing sites in your portfolio that depend on a CBPF. Which already have MDSAP? Which do not? When does each certificate expire?
- Run a readiness assessment. Compare your current quality management system with MDSAP requirements and identify the gaps before an auditor does.
- Prepare your team. Professionals who understand the logic of the MDSAP audit reduce rework, nonconformities and certification time.
- Follow the public consultation. When it opens, that will be the time to read the proposed text carefully and, where it makes sense, submit contributions to Anvisa. It is the sector's chance to shape the rule before it is defined.
HSC Global walks with you through this transition
HSC Global Group closely follows medical device regulation in Brazil and worldwide, and works with MDSAP every day. We support manufacturers, importers and registration holders with MDSAP consulting, readiness assessments and MDSAP auditor training.
If your manufacturing partner has already asked that Monday-morning question, or if you want to be ready before it arrives, talk to our team. Together we will understand where your company stands today and what it still needs to reach the day the rule changes with confidence.
This article will be updated as soon as Anvisa opens the public consultation.
Sources
- AnvisaMinutes of the 20th Ordinary Public Meeting of the Collegiate Board
- AnvisaVote No. 215/2025/SEI/DIRE5, Process No. 25351.944190/2025-86
- AnvisaOrdinance No. 1,484/2025, 2026-2027 Regulatory Agenda (Annex I, item 5.6)
- AnvisaRDC No. 687/2022: criteria for granting and renewing the CBPF for medical devices
- AnvisaAnvisa takes part in the MDSAP 2026 Forum
- ABIMEDABIMED reforça protagonismo internacional no Fórum MDSAP 2026, em Kyoto
- Emergo by ULBrazil ANVISA Announces Priorities for the 2026-2027 Year
- Emergo by ULMDSAP Updates and Possible Requirement in Brazil
- Emergo by ULBrazil GMP extension for medical device companies under MDSAP (RDC No. 850/2024)
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