Views: 0 Author: Site Editor Publish Time: 2026-04-24 Origin: Site
As the largest medical device market in Latin America, Brazil imported US$9.79 billion worth of medical devices in the first quarter of 2024, a year-on-year increase of 20.49%. The Brazilian medical device market is expected to reach US$11.12 billion in revenue by 2025. However, ANVISA registration is often described as “T0 level difficulty” – the complexity of the process and the long lead times deter many Chinese manufacturers. This article provides a practical breakdown, focusing on the Portuguese translation and notarization requirements for GMP certificates, to help exporters avoid common pitfalls.
The market access for medical devices and hygiene products in Brazil is the responsibility of the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária – ANVISA). ANVISA, under the Ministry of Health, is responsible for pre-market approval and post-market control of all medical devices, in vitro diagnostic products, and other health-related products (including drugs, hygiene products, cosmetics, etc.). In Brazil, the manufacturing, import, storage, transportation, and sale of these products require authorization from ANVISA.
Brazil’s medical device regulatory framework has undergone significant reforms in recent years. The following are the currently effective core regulations:
⚠️ Important Regulatory Update
Many companies still refer to outdated regulations such as RDC 16/2013 and RDC 185/2001. Please be aware that these have been formally replaced. Prepare your documents according to the latest regulations:
Regulation |
Status |
Key Content |
RDC 751/2022 |
In force |
Comprehensive medical device regulation, effective March 1, 2023, replacing old RDC 185/2001. Covers definitions, classification rules, labeling requirements, and registration, highly aligned with EU MDR |
RDC 665/2022 |
In force |
GMP requirements, establishing technical requirements for Brazilian Good Manufacturing Practices (BGMP), replacing RDC 16/2013 |
RDC 830/2023 |
In force |
In vitro diagnostic medical device regulation, aligned with EU IVDR |
RDC 497/2021 |
In force |
Administrative procedures for granting GMP certification |
RDC 850/2024 |
In force |
Manufacturers holding MDSAP certificates can extend BGMP certificate validity from two to four years |
RDC 848/2024 |
In force |
Establishes simplified approval mechanism based on international regulatory reliance |
IN 290/2024 |
In force |
Allows reference to assessment results from recognized authorities such as US FDA and EU CE, simplifying duplicate reviews |
ANVISA classifies medical devices into four risk classes, similar to EU MDR:
Class |
Risk Level |
Typical Products |
GMP Requirement |
Class I |
Low risk |
Bandages, masks, gloves, thermometers, medical underpads |
BGMP certification not required, but a quality system must be established |
Class II |
Medium risk |
Blood pressure monitors, glucose meters, syringes, non-sterile hygiene products |
BGMP system required, but no on-site audit |
Class III |
High risk |
Artificial joints, pacemakers, cardiac stents |
BGMP certification required (on-site audit possible) |
Class IV |
Very high risk |
Artificial heart valves, implantable neurostimulators |
BGMP certification required (strict on-site audit) |
Special note: Hygiene product registration requirements
For hygiene products (e.g., adult underpads, diapers, sanitary napkins), classification depends on whether the product is sterile or has antimicrobial properties. Non-sterile ordinary sanitary napkins/pads are typically Class I and require registration. Products containing antibacterial ingredients, gels, or making antimicrobial claims are generally Class II with stricter registration requirements. Sterile medical-grade underpads are usually Class II or above; some may be classified as Class III (e.g., for wound care). It is recommended to conduct a detailed classification assessment of the product or similar registered products to ensure the correct registration pathway is followed.
The BGMP certificate is not only a regulatory requirement but also a key factor determining registration costs. BGMP requirements and costs vary significantly by product class:
Class I (low risk): BGMP certification not required, no GMP audit fees. Registration timeline approximately 3-6 months. Basic fees approximately 6,000-12,000 BRL. Estimated total cost: 10,000-20,000 BRL
Class II (medium risk): BGMP certificate not required, but compliance with BGMP quality system requirements is necessary; no on-site audit. Registration timeline approximately 6-12 months. Registration fees approximately 10,000-18,000 BRL. Estimated total cost: 20,000-30,000 BRL
Class III/IV (high risk): BGMP certification (with on-site audit) is mandatory. “GMP certification fee + registration fee” can reach 50,000-80,000 BRL. The BGMP certificate application fee is 72,809.40 BRL (approximately US$15,000), payable regardless of whether the manufacturer holds MDSAP. Registration timeline typically 12-24 months, but including BGMP audit queuing, Class III/IV BGMP review cycles may take as long as 2 or even 4 years. Estimated total cost: 60,000-100,000 BRL
For manufacturers of underpads and diapers: If the product is exported as a non-sterile hygiene product, it is typically Class I or II, requiring no BGMP on-site audit, with manageable costs and timelines. However, if the product is claimed to be medical-grade, sterile, or has antimicrobial properties, it may be classified as Class II or even III, requiring a medium/high-risk pathway with significantly higher costs and longer timelines. Proper classification is critical to avoid budget miscalculations.
ANVISA accepts the following two methods to obtain a BGMP certificate:
Pathway |
Condition |
Certificate Validity |
Applicability |
Direct application |
Submit application directly to ANVISA; on-site audit decision based on risk analysis |
2 years |
Manufacturers without MDSAP certificate |
MDSAP certificate exemption |
Valid MDSAP (Medical Device Single Audit Program) certificate |
4 years |
Manufacturers that have passed MDSAP audit may be exempt from ANVISA on-site audit |
Holder is the BRH (Brazil Registration Holder). The BGMP certificate must be held by a BRH.
Renewal: Renewal applications must be submitted 180-270 days before expiration.
Audit queuing: Due to limited ANVISA review resources, queuing for direct BGMP applications can take up to 2 years.
Foreign manufacturers must appoint a Brazilian registration holder, responsible for application submission, document filing, and post-market surveillance.
⚠️ Critical Section – The Most Important in Practice
Many Chinese companies fail because their GMP certificate translations and notarizations are non-compliant, leading to rejected applications and months or even years of wasted time. ANVISA requires that all documents, including GMP certificates, be translated into Portuguese and certified by a Brazilian notary office.
The following documents must undergo Portuguese translation and notarization:
GMP Certificate / BGMP Certificate
ISO 13485 Quality System Certificate
Power of Attorney
Free Sales Certificate
Technical documentation (product description, performance test reports, etc.)
Labels and Instructions for Use (must be in Portuguese, including ANVISA required warning symbols)
Risk analysis reports
Clinical evaluation data
Step 1: Prepare originals
Ensure original documents (GMP certificate, ISO certificate, etc.) are accurate and complete as the basis for certified translation.
All non-Portuguese original documents must first be translated into Portuguese by a professional translation company.
Ensure translation consistency with originals, especially for key information such as company name, address, certificate number.
Step 2: Notarization
Submit the translated documents together with the originals to a Brazilian notary office for certified translation.
ANVISA explicitly requires that certified translations be performed by a Brazilian notary office; notarization in other countries is not accepted.
The Brazilian notary office will certify the authenticity of the translated documents.
Step 3: Using notarized documents
Submit the notarized Portuguese versions together with the technical dossier to ANVISA.
Ensure all notarized documents remain valid at the time of ANVISA review. ANVISA may require that the signing date of documents be within 1 year of the registration application submission (check current regulations), otherwise re notarization is required.
✅ Correct approach:
Engage professional translation agencies or consultants with knowledge of Brazilian law or ANVISA registration experience to ensure terminological accuracy.
Have all notarized documents reviewed and validated by a local Brazilian BRH or authorized representative to prevent rejection due to formatting issues.
Plan the translation/notarization timeline in advance: translation → notarization → document preparation in parallel to avoid delays.
Prepare technical documentation strictly in accordance with the formats and content requirements of the latest ANVISA regulations (RDC 665/2022, RDC 751/2022).
If the original document content changes (e.g., certificate renewal, power of attorney extension), re notarization must be performed synchronously.
❌ Common mistakes (to avoid):
Choosing any random agency for Portuguese translation, resulting in terminology non-compliant with ANVISA requirements.
Forgetting to notarize the critical GMP certificate in Brazil – ANVISA will reject the document outright.
Confusing “ordinary translation” with “certified translation” – ANVISA only accepts certified translations from Brazilian notary offices.
Neglecting the translation and notarization of MDSAP certificates or ISO 13485 certificates, leading to incomplete documentation.
Inaccurate document translation is a root cause of registration delays for many Chinese companies.
During the translation and notarization process, companies should also protect sensitive information in documents such as GMP certificates. Recommended confidentiality measures when engaging translation agencies:
Sign a Confidentiality Agreement stipulating that the translation agency shall not disclose business sensitive information (GMP certificates, technical drawings, formulations, etc.) to third parties.
Require the translation agency to destroy all copies of original files after notarization, keeping only one official notarized copy for archiving.
Clearly state in the Power of Attorney that documents are to be used solely for ANVISA registration, not for any other purpose.
If the GMP certificate contains detailed manufacturing process parameters or formulation information, consider redacting non essential critical data or signing a stricter confidentiality agreement with the translation agency.
For Class III and IV medical devices requiring clinical data, approval from an ethics committee is also required. Specific requirements include:
Clinical trials must be conducted at Brazilian healthcare institutions and must be approved by an ANVISA recognized ethics committee.
Documents such as clinical protocols and informed consent forms also require Portuguese translation and notarization. Informed consent translations must ensure that subjects fully understand the content.
The ethics committee’s approval opinion must be submitted as part of the registration dossier. If the approval document is in Portuguese, it also requires notarization.
For hygiene products (e.g., underpads, diapers), unless the product makes special claims (e.g., antimicrobial, medical grade), clinical trial data and ethics approval are typically not required – only product performance test reports are needed.
ANVISA has strict requirements for authorized signatures on documents such as GMP certificates:
The original GMP certificate must be signed by an authorized representative of the manufacturer (typically the quality manager or legal representative) and bear the company seal.
The Portuguese translation must indicate the qualifications of the translation agency and translator, and be stamped by the notary office.
Power of Attorney: The document authorizing a Brazilian BRH to submit GMP certificates and related documents must be notarized/apostilled (depending on whether Brazil is a member of the Hague Apostille Convention). As of 2024, Brazil has acceded to the Hague Convention, so Chinese documents can be simplified via apostille.
The signature style should be consistent with that used by the manufacturer on other formal documents in the South American market to avoid ANVISA questioning the document’s authenticity.
Labels and instructions for use are key focus areas for ANVISA review and must also satisfy the following:
Must be in Portuguese – translation must be accurate and professional.
Labels must include the name of the Brazilian registration holder and the name of the technical responsible.
The ANVISA registration number must be clearly displayed, not adjacent to other marks.
For medical devices, standardized ANVISA warning symbols must be included.
After translation, it is recommended to have the labels and IFU reviewed by a local Brazilian agent or validated for localization to ensure compliance with Brazilian consumer language habits.
The following table summarizes the most frequent problems encountered during the translation and notarization of GMP certificates. Use it as a self checklist:
Issue Category |
Common Mistake |
Recommendation |
Translation language |
Using English instead of Portuguese |
All documents must be translated into Brazilian Portuguese |
Notary office compliance |
Notarization performed in mainland China |
Must be certified by a Brazilian notary office |
Notarization type confusion |
Using ordinary translation instead of certified translation |
ANVISA only accepts certified translations from Brazilian notary offices |
Missing key documents |
Notarizing only the GMP certificate, ignoring ISO 13485, etc. |
Both GMP and ISO 13485 certificates require notarized translation |
Timeliness |
Using documents notarized more than 1 year ago |
Ensure signing dates are within 1 year of submission |
Inconsistent translation |
Inconsistent translation of key information (e.g., manufacturer name, address) |
All notarized documents must have consistent key information |
Technical documentation not translated |
Translating only administrative documents, leaving technical documents in Chinese |
All technical documentation must be translated |
Regulatory version confusion |
Using outdated RDC 16/2013 requirements to prepare notarized documents |
Use Cadastro simplified process for Class I/II; Registro full registration for Class III/IV |
Have all documents (GMP certificate, ISO 13485 certificate, Power of Attorney, Free Sales Certificate, etc.) notarized simultaneously by a Brazilian notary office to avoid piecemeal processing that extends timelines. Meanwhile, Portuguese translation of technical documents and localization validation of labels/IFU can proceed in parallel with GMP certificate notarization, helping to shorten the overall registration cycle by approximately 2-3 months.
Critical timeline note: For Class III/IV products, BGMP audit queuing is inevitable – start immediately after authorization.
If you already hold a MDSAP certificate, you can use it to apply for a 4-year BGMP certificate from ANVISA, with the possibility of exemption from on site audit, significantly reducing queuing time.
If your product already has approvals such as US FDA, EU CE, use the simplified procedures under RDC 848/2024 and IN 290/2024 to shorten review timelines.
Many Chinese companies experience delays due to inaccurate document translation, test reports that do not comply with Brazilian specific standards, or incomplete quality system documentation. It is advisable to incorporate regulatory requirements at the product design stage and start key document translation/notarization early.
Engage an experienced local registration holder to interface with ANVISA; they can better understand reviewers’ concerns and avoid back and forth cycles caused by inadequate responses.
The complexity of ANVISA medical device registration in Brazil should not be underestimated, but with systematic strategy and precise preparation, the process can be significantly accelerated. The Portuguese translation and notarization by a Brazilian notary office of GMP certificates is the most easily overlooked and yet most likely to cause registration failure of all technical documents. Make sure to:
✅ Have all required documents ready (GMP certificate, ISO 13485, Power of Attorney, etc.)
✅ Have all non-Portuguese documents certified by a Brazilian notary office
✅ Ensure translation accuracy and compliance with ANVISA terminology requirements
✅ Ensure all documents remain valid at the time of submission
✅ Engage a local Brazilian registration holder (BRH) to assist with document review
✅ Keep track of regulatory updates and classification changes
Successful ANVISA registration is only the beginning of market entry in Brazil. Post market obligations such as annual reports, change notifications, and vigilance reports are equally important. It is recommended that companies establish a long term compliance management system to not only facilitate initial registration but also lay a solid foundation for future product line expansion, ultimately achieving sustainable growth in Latin America’s largest medical market.
