Importing Menstrual Cups into Brazil: Anvisa Requirements
BRAZIL IMPORT GUIDE / MENSTRUAL CUPS
Quick answer: what does a buyer need to import menstrual cups into Brazil?
A menstrual cup shipment entering Brazil should be planned around the Brazilian importer’s sanitary responsibilities, not only the exporter’s product documents. Anvisa’s RDC No. 640/2022 specifically includes menstrual cups in its rules for disposable personal hygiene products. The framework requires prior electronic communication/notification rather than a conventional product registration, and the Brazilian company responsible for the product must hold the applicable company authorization and sanitary license for the activities it performs.
In this guide
Our Brazil cooperation / Product classification / Notification / Importer licenses / Safety tests / Microbiology / Portuguese label / Technical dossier / Import responsibilities / Shipment checklist / FAQ / Official sources
For a compliant project, the buyer and manufacturer should align at least these items before shipment:
- The Brazilian responsible company and its Anvisa authorization scope.
- The product’s electronic regularization/notification status.
- Portuguese labeling and instructions for use.
- Material safety and product-finished safety evidence.
- Microbiological test results for the finished product.
- Product-use life and discard-time evidence.
- Import documents and the sanitary import procedure applicable to the shipment.
- A clear division of responsibility between the Brazilian importer, brand owner and overseas manufacturer.
This article is a practical supplier-side checklist, not legal advice. The Brazilian importer, its responsible technical professional and a qualified local regulatory consultant should confirm the current requirements before each commercial launch or product change.
A six-year Brazil cooperation case: what can buyers learn?
In 2020, WQ Silicone began working with a Brazilian business customer on menstrual cup exports. By 2026, the cooperation has continued for more than six years.
The value of this case is not a claim that one supplier can replace the Brazilian importer’s regulatory role. The practical lesson is that long-term export cooperation depends on maintaining consistency across product specifications, safety documents, packaging, instructions and shipment records over time.
For a menstrual cup project, a durable supplier relationship should make it easier to:
- keep the same product identity across production batches;
- update packaging and Portuguese instructions in a controlled way;
- organize safety and microbiological records;
- trace batches and resolve questions after delivery; and
- coordinate product changes with the Brazilian product holder before commercial launch.
The customer’s identity, order quantities, commercial prices and regulatory filing details are not disclosed in this article.
How does Anvisa classify a menstrual cup?
Anvisa defines a menstrual cup as an intravaginal device used to collect menstrual flow. Anvisa also lists “coletor menstrual” among products that are not regularized as medical devices. This means a standard menstrual cup should not automatically be presented as a medical device simply because it is inserted into the body.
The intended use and the claims on the packaging still matter. Medical, therapeutic or disease-treatment claims can change the regulatory analysis. A supplier should therefore avoid unsupported claims such as “treats infection,” “prevents disease” or “medical-grade protection” unless the Brazilian regulatory classification and supporting evidence have been reviewed.
Source: Anvisa product classification list
Is a menstrual cup registered or notified in Brazil?
Under RDC No. 640/2022, products in the covered disposable personal hygiene category are exempt from conventional registration. Commercialization is conditioned on prior communication to Anvisa by the product-holding company, through the electronic notification procedure.
For a menstrual cup project, the Brazilian responsible company should confirm:
- which company will be the product holder in Brazil;
- whether the product notification has been completed in the applicable Anvisa electronic system;
- whether the notification information matches the brand, product name, intended use, material and packaging;
- whether any change to the product, label or responsible company requires an update; and
- whether the notification documents and responsibility term are retained for inspection.
The notification route does not mean that the product is exempt from evidence. RDC No. 640/2022 places responsibility on the product holder to maintain information demonstrating product quality, safety and the accuracy of labeling claims.
Source: Article 3
Does the Brazilian importer need an AFE and sanitary license?
Yes. RDC No. 640/2022 states that companies manufacturing or importing the covered products must have an Anvisa Company Operating Authorization, known as AFE, for the relevant activities and product classes. The company must also have a license from the competent sanitary authority.
The exact scope should be checked against the Brazilian company’s actual role. Importing, storing, distributing and selling may involve different operational responsibilities. The Brazilian importer should verify that its AFE and local sanitary license cover the activities performed at its facilities and that the product category is correctly addressed.
The overseas factory should not assume that its own export license replaces the Brazilian importer’s authorization. The Brazilian company is normally the party responsible for the local regularization and for the product’s commercial operation in Brazil.
Source: Article 8
What safety tests are expected for menstrual cups?
RDC No. 640/2022 specifies finished-product safety evidence for menstrual cups, including:
| Safety area | Requirement to plan for |
|---|---|
| Cytotoxicity | Test according to ISO 10993-5 |
| Vaginal mucosa irritation | Human irritation assessment |
| Dermal sensitization | Sensitization assessment |
| Human evaluations | The irritation and sensitization assessments described in the resolution require at least 30 volunteers when performed in humans |
| Safety conclusion | A technical safety opinion and a summary attesting safe use must be maintained/presented as required |
The buyer and manufacturer should confirm that test reports identify the correct finished product, material, formulation or color variant, sample, test method and responsible laboratory. A generic silicone-material certificate may not by itself demonstrate safety of the finished menstrual cup.
Source: Articles 35-36
What microbiological requirements apply?
For the finished menstrual cup, RDC No. 640/2022 requires absence of the following microorganisms in the specified sample evaluation:
- Escherichia coli;
- Pseudomonas aeruginosa;
- Staphylococcus aureus;
- Clostridium species; and
- Candida albicans.
The resolution also sets maximum limits for aerobic mesophilic microorganisms and for fungi and yeasts. The reported limits are based on a 10-gram sample: aerobic mesophilic microorganisms must not exceed 500 CFU per gram, and fungi and yeasts must not exceed 100 CFU per gram.
Testing should be connected to the finished product and the applicable production controls. Buyers should ask how samples are selected, how batches are identified and how nonconforming results are handled.
Source: Article 37
What must appear on the Portuguese label?
Imported products must contain the required labeling statements in Brazil’s official language, Portuguese. The resolution permits the required information to be added by an over-label or supplementary label when the original label does not contain it, subject to the applicable requirements.
The general labeling checklist includes:
- product name and product type;
- brand;
- the product holder’s AFE information;
- lot or batch identification;
- expiry date, when applicable;
- contents;
- country of origin;
- product holder and CNPJ;
- product holder’s address;
- instructions for use;
- warnings and restrictions;
- specific labeling information;
- composition information as applicable; and
- a consumer communication channel.
For menstrual cups specifically, the label should address:
- Toxic Shock Syndrome (TSS) guidance.
- How to use the product and how often to remove it to empty menstrual flow.
- How to select the appropriate size for the user’s menstrual flow.
- The brand’s sizes and flow-use characteristics.
- The discard time, supported by tests showing that the product maintains its properties under the stated conditions of use.
- Hand hygiene before and after insertion.
- Removal within the manufacturer’s stated time.
- Seeking medical assistance if the product cannot be removed.
- Storage and care instructions.
- Appropriate packaging and storage after use.
- A recommendation that users with uterine prolapse, retroversion or anteflexion consult a physician before use.
The exporter should prepare the technical content, but the Brazilian product holder should approve the Portuguese wording and confirm that the final commercial label matches the notified product.
Source: Articles 11-13, 38 and Annex III
What technical documents should the importer request from the manufacturer?
A practical pre-shipment dossier can include:
| Document group | Examples of records to prepare |
|---|---|
| Product identity | Product name, brand, model, sizes, intended use and product specification |
| Materials | Material specification, colorant information and supplier safety documents |
| Finished-product safety | Cytotoxicity, vaginal mucosa irritation and dermal sensitization evidence |
| Microbiology | Finished-product microbiological test report and batch identification |
| Product life | Stability information and evidence supporting the stated discard time after use begins |
| Manufacturing | Process description, in-process controls, cleaning and quality-control records |
| Packaging and label | Packaging specification, Portuguese label artwork and instructions for use |
| Traceability | Lot coding, production records, inspection records and complaint-handling route |
| Commercial shipment | Commercial invoice, packing list, transport documents and any documents requested for the applicable import filing |
The resolution’s Annex I distinguishes information that should be maintained at the company from summaries or information that may be presented for product regularization. The Brazilian product holder should maintain the complete technical file and be able to present it to the sanitary authority when requested.
Source: Annex I
What is the importer’s role during sanitary importation?
The Brazilian importer should confirm the import route and sanitary import filing applicable to the product and shipment. Products subject to sanitary surveillance may require electronic import procedures through the relevant Brazilian government systems, and the exact filing depends on the product classification, importer status, customs information and current rules.
The exporter should provide consistent documents and avoid changing the product name, material description, label, model or quantity between the technical dossier and the commercial shipment. Inconsistencies can delay customs clearance or create a regulatory question even when the physical product is unchanged.
Before shipment, the two parties should agree on:
- who submits the Brazilian sanitary import request;
- who owns the product notification;
- who approves the Portuguese label;
- who retains the technical and test file;
- who responds to complaints or adverse events;
- who controls product changes; and
- who pays for additional testing or relabeling if the authority requests it.
Brazil menstrual cup import checklist before the first shipment
Use this short checklist with the Brazilian importer and the manufacturer:
- Confirm the intended use and avoid unsupported medical claims.
- Confirm the Brazilian product holder and importer.
- Check the importer’s AFE and local sanitary license scope.
- Complete or verify the applicable Anvisa electronic notification.
- Match the product name, brand, sizes and materials across all records.
- Complete the required finished-product safety assessments.
- Complete microbiological testing and document batch traceability.
- Prepare evidence supporting the stated product-use life and discard time.
- Approve Portuguese label artwork and instructions.
- Confirm TSS, hygiene, removal, storage and medical-consultation warnings.
- Align the sanitary import filing and customs documents.
- Establish change control, complaint handling and record retention.
Frequently asked questions
Do menstrual cups need medical-device registration in Brazil?
Not automatically. Anvisa lists menstrual cups among products not regularized as medical devices, while RDC No. 640/2022 provides the specific personal-hygiene-product framework. The intended use and claims should still be reviewed before commercialization.
Is Anvisa notification the same as product registration?
No. RDC No. 640/2022 describes a prior electronic communication/notification procedure for products covered by the resolution and states that they are exempt from conventional registration. The product holder remains responsible for safety, quality, labeling and compliance evidence.
Can a foreign manufacturer notify the menstrual cup directly with Anvisa?
The Brazilian regulatory workflow should be handled through the Brazilian company responsible for the product. The importer or product holder should confirm the appropriate account, authorization and notification procedure with Anvisa or a local regulatory professional.
Can the product keep an English-only label?
Imported products must contain the required labeling statements in Portuguese. Other languages may appear in parallel, but an English-only label should not be assumed to satisfy the Brazilian requirement.
Does a silicone material certificate prove menstrual cup compliance?
Not by itself. The finished product also needs the safety and microbiological evidence required for the menstrual cup category, along with label, traceability and product-life documentation.
Does a long export relationship replace Brazilian sanitary licensing?
No. A long-term supplier relationship can improve document control and production consistency, but the Brazilian importer and product holder remain responsible for the applicable local authorizations, notification and sanitary obligations.
Regulatory sources
- Anvisa, Resolution RDC No. 640 of March 24, 2022 — Official Gazette of Brazil
- Anvisa, Personal Hygiene Products, Cosmetics and Fragrances — regulatory overview
- Anvisa, Products not regularized as medical devices
- Anvisa, review and consolidation of cosmetics and personal-hygiene regulations
- Anvisa FAQ on Portuguese ingredient labeling and RDC No. 898/2024
Editorial note: Brazilian sanitary requirements can change, and the applicable procedure may depend on the product’s claims, importer role, packaging, shipment and current electronic systems. Confirm the current position with Anvisa, the Brazilian importer’s responsible technical professional and a qualified Brazilian regulatory adviser before placing the product on the market.
