Platform

Overview Capabilities and architecture Data domains ADAM · AI applied to master data Reference sources How we implement Security and ISO 27001

Solutions

Supplier qualification Customer onboarding Material standardization (PDM) Service standardization (PDS) PIM · product information Material data cleansing Customer and vendor data cleansing Tax Reform

Industries

Agribusiness Industry and manufacturing Consumer goods (CPG) Retail Healthcare and pharmaceuticals Energy and infrastructure Financial services Technology, services, and logistics

Services

Consulting and diagnostics Master data cleansing Data migration and SAP S/4HANA Data as a Service MDM Engineering

Partnerships

Overview Finder Whitelabel Co-projects SAP migration projects Niche and middle-market ERPs

Resources and company

Amigos do Cadastro Blog and content Demos Events and webinars Success stories MDM Academy About 4MDG
Request a demo

Blog · 11 November 2026 · Paulo Cordeiro

Hospital medical supplies master data cleansing with Brazil's Anvisa

How to cleanse hospital supplies and OPME master data with Anvisa open data in Brazil: risk class, notification vs registration, validity and who decides.

To cleanse hospital medical supplies master data in Brazil, use the product's registration or notification number at Anvisa (Brazil's health regulatory agency) as the matching key. With that key, you can match the whole base against Anvisa's open data and check risk class, holder, manufacturer and validity in bulk. Items that do not match, expired items and the decision to merge codes go to regulatory affairs, pharmacy, nursing and procurement, each for its own part.

In a hospital material master, it is common to find the same catheter under three codes: one by the box, one by the unit, a third with the brand name in the description, and none with the Anvisa number filled in. Pharmacy dispenses by the unit, procurement negotiates by the box, and the warehouse receives whatever the invoice says.

With OPME (orthoses, prostheses and special materials, a Brazilian category for implants and high-cost surgical devices) the same scene carries more weight. An orthopedic fixation system arrives with components in several sizes, the Anvisa registration covers the family, and the master has one generic code for everything. When the hospital needs to trace what was used on which patient, the code does not help.

This guide covers what is specific to healthcare within material master data cleansing: how to use Anvisa regularization to check the base that already exists in the ERP or hospital system. The focus is the data, not the clinical choice of the item, which belongs to the hospital's standardization committee. Medicines follow different logic (drug registration and the DCB, Brazil's official list of common drug names) and are left for another article.

The rules below are Brazilian and apply in Brazil.

What do Brazilian rules say about risk classes, notification and registration?

For Anvisa, a healthcare material is a non-active health product. It falls into one of four classes: I (low risk), II (medium risk), III (high risk) and IV (maximum risk), under 22 rules in Annex I of RDC 751/2022 (an Anvisa resolution). The intended use stated by the manufacturer determines the class, and when a product has functions from different classes, the most critical one applies (Anvisa, classification of materials).

RDC No. 751 of September 15, 2022 organizes regularization as follows:

  • Classes I and II: subject to notification (art. 6). Anvisa's manual for this regime confirms that these materials are exempt from registration and that notification has no prior technical review, although Anvisa may assess the product at any time (Anvisa, notification manual).
  • Classes III and IV: subject to registration (art. 7).
  • Registration validity: 10 years (art. 11), and it may be renewed successively for the same period, according to Anvisa's registration manual for materials.
  • Families, systems and kits: notification or registration may be granted for families, systems and kits (art. 3).

That last point matters for the master. One Anvisa number can cover several models and sizes, so the number alone does not identify the item you buy.

Which Anvisa data can be used to check the base in bulk?

Anvisa publishes the file TA_PRODUTO_SAUDE_SITE.csv on its open data portal. In the file opened on November 11, 2026, the field DT_ATUALIZACAO_DADO (data update date) showed October 11, 2026. Column names are in Portuguese; the ones that matter for the master are:

  • NUMERO_REGISTRO_CADASTRO (registration or notification number) and NUMERO_PROCESSO (process number);
  • NOME_TECNICO (technical name) and NOME_COMERCIAL (trade name);
  • CLASSE_RISCO (risk class);
  • CNPJ_DETENTOR_REGISTRO_CADASTRO (holder's CNPJ, the Brazilian company tax ID) and DETENTOR_REGISTRO_CADASTRO (holder);
  • NOME_FABRICANTE (manufacturer) and NOME_PAIS_FABRIC (country of manufacture);
  • DT_PUB_REGISTRO_CADASTRO (publication date) and VALIDADE_REGISTRO_CADASTRO (validity; the values seen were "VIGENTE", meaning in force, or a date).

The same portal has a file named TA_PRODUTO_SAUDE_MODELO.csv, which by its name deals with models. It is worth opening it to see whether it helps in your case.

Our recommendation: use the file for bulk matching and keep the download date with it. Before any decision about a specific item (block it, merge it, change supplier), confirm it case by case in Anvisa's official product search.

What does the OPME manual recommend having in the master?

The Manual of Good Practices for OPME Management, from Brazil's Ministry of Health (2016), is a good practice guide, not a regulation. Among the basic rules it recommends for purchasing OPME, the manual lists these fields for the OPME master:

  • trade name of the product, family or system;
  • commercial model;
  • serial number or identification of each model or part;
  • Anvisa registration number of the product or family, and registration expiry date;
  • risk classification (rule and class);
  • manufacturer (domestic or foreign) or importer (the company responsible for the Anvisa registration), with CNPJ, legal name, trade name and brand;
  • country of manufacture.

The manual also recommends checking traceability labels at receiving (manufacturer, lot or serial number, expiry and Anvisa registration) and keeping a traceability system, computerized if possible, that links material, lot, registration, date of use, professional, patient, supplier and invoice. That tracing depends on a master that separates family, model and size.

How do you cleanse hospital medical supplies master data step by step?

1. Separate materials from medicines and flag OPME

Materials and medicines follow different rules at Anvisa. Start by separating the groups and flagging OPME items, which need extra attributes (family, model, size, part identification).

2. Fill in the Anvisa number where it is missing

Without the key, there is no matching. Recover the number from the invoice, the label or the supplier's data sheet. Normalize the format (leading zeros, dots, spaces) on both sides before matching against the Anvisa file.

3. Match against the official base and sort the result

Each item lands in one of four queues: found and consistent; found with a discrepancy (class, holder, technical name); found with a past validity date; not found. Only the first queue moves on without someone's decision.

4. Check holder, manufacturer and class

Holder and manufacturer are different fields, and hospitals often have only one of them, sometimes with the distributor's name. Standardize from the holder's CNPJ. A risk class discrepancy is not fixed directly in the master: it goes to regulatory affairs.

5. Separate purchase packaging, presentation and dispensing unit

A box of 50 and a single unit are not two products; they are two ways of moving the same item. We recommend separate fields for purchase packaging, presentation and dispensing unit, with the conversion factor between them. We recommend that pharmacy define the dispensing unit, together with nursing.

6. Handle duplicates by registration, model and size

The same registration does not mean the same item, because of families and systems. A strong duplicate candidate is a pair of codes with the same Anvisa number, the same model and the same size. The general criteria for choosing the surviving code are in the guide on how to identify duplicate materials.

7. Rewrite the description with a PDM and check classification codes

With technical name, model and size separated, the description can follow a PDM (standardized material description template) instead of each person's typing. The approach is in the article on how to write material descriptions. In the same batch, check that NCM and CEST are filled in for materials and NBS for the services the hospital contracts, such as outsourced sterilization or equipment maintenance, plus UNSPSC when the company uses that classification for procurement. NCM (goods classification), CEST (tax substitution code) and NBS (services classification) are Brazilian codes; treat them as attributes to validate with your tax team. The NCM routine is in the NCM review of the material master.

8. Plan a field for the UDI

RDC No. 591/2021 brought UDI, the unique device identification system, into Brazilian rules. The obligations to assign it, place it on the device and submit the information belong to the manufacturer or holder, with deadlines staggered by type of obligation and risk class, and the SIUD database (Anvisa's UDI database) has been in operation since March 1, 2026 (Anvisa, UDI). Our operational reading: it makes sense for the master to include a field for the UDI identifier, without treating it as a replacement for the registration number.

What can be fixed in bulk and what needs a decision?

The decision column is our recommendation, not an Anvisa rule. Adjust it to the structure of your hospital or distributor.

Master attributeWhere to checkWhat to fix in bulkWhat needs a decision (and whose)
Registration or notification numberAnvisa open data (NUMERO_REGISTRO_CADASTRO) and official product searchFormat, spaces and zeros; fill in from invoice, label or supplier data sheetNumber not found: regulatory affairs or responsible technician
ValidityVALIDADE_REGISTRO_CADASTROFlag items with a past date for reviewBlock purchasing or keep: regulatory affairs with procurement
Risk classCLASSE_RISCOFill in where empty; flag discrepanciesFix a divergent class: regulatory affairs
Holder and manufacturerCNPJ_DETENTOR_REGISTRO_CADASTRO, DETENTOR_REGISTRO_CADASTRO, NOME_FABRICANTE, NOME_PAIS_FABRICStandardize legal name from the CNPJ; separate holder from distributorChange of supplier or holder: procurement
Technical name and trade nameNOME_TECNICO and NOME_COMERCIALBasis for the PDM descriptionStandard description text: master data team with pharmacy or nursing
Family, model, size and part (OPME)Label, supplier documentation and fields recommended in the OPME manualSeparate model and size into their own attributesWhat is its own item and what is a component: operating room or sterile processing with procurement
Purchase packaging, presentation and dispensing unitInvoice and supplier data sheetCreate fields and conversion factorDispensing unit: hospital pharmacy with nursing
UDIProduct labelPlan the field; empty is not an errorUse of UDI at receiving: procurement with IT
NCM, CEST, NBS and UNSPSCMaster and tax documentsEmpty fields and formatClassification: tax team
Duplicate codesSame Anvisa number, model and sizeBuild the candidate listMerge and surviving code: master data team with procurement and the area that uses the item

What does this look like in a concrete case? (hypothetical example)

Hypothetical example, created for illustration only. It is not a client case and uses no real registration numbers.

A hospital has three codes for a peripheral intravenous catheter of the same gauge: "IV CATHETER 20G", "PERIPHERAL INTRAVENOUS CATHETER 20G BOX OF 50" and "CATHETER 20 BRAND X". None has the Anvisa number.

  1. The team recovers the number from the invoices. The first two point to registration A. The third points to registration B, from another holder.
  2. In the Anvisa file, A and B show the same technical name and different holders. They are different products in the master, even with similar descriptions.
  3. The two codes under registration A differ only in packaging: one by the unit, the other in a box of 50. Pharmacy confirms it dispenses by the unit. One code remains, with the box as purchase packaging and the unit as dispensing unit. The other goes to the merge queue.
  4. For B, the validity column shows a date that has already passed. The master data team does not block it alone: it goes to regulatory affairs, which checks the official search and decides with procurement.
  5. In the same batch, an orthopedic fixation system registered under one generic code gets model and size attributes, following the fields the OPME manual recommends. The operating room and procurement define which components become their own items.

Where to start

  1. Separate materials, medicines and OPME in the base.
  2. Download TA_PRODUTO_SAUDE_SITE.csv from Anvisa's open data and keep the download date.
  3. Create the missing attributes: Anvisa number, risk class, holder, manufacturer, model, size, purchase packaging, dispensing unit and a field for the UDI.
  4. Fill in the Anvisa number for items without a key, from source documents, and match against the official base.
  5. Set up the decision queues: regulatory affairs for expired items, class discrepancies and items not found; pharmacy and nursing for the dispensing unit; tax team for NCM, CEST and NBS; procurement for merges.
  6. Start with the highest-consumption items and with OPME. The material master data cleansing checklist covers the general fields, and the article on agricultural inputs cleansing with Brazil's MAPA registration shows the same official-key logic in another sector.

Frequently asked questions

Does a notification expire like a registration?

RDC 751/2022 sets, in art. 11, a 10-year validity for registration, which can be renewed. For products under the notification regime, art. 28 of the same RDC states that they are exempt from revalidation. Even so, in the master, use what the official base shows for each item in the VALIDADE_REGISTRO_CADASTRO column and confirm it in Anvisa's search.

Is the Anvisa number enough to identify the item in the master?

No. Notification or registration may be granted for families, systems and kits (RDC 751/2022, art. 3). One number can cover several models and sizes. To identify the item, combine the number with model, size and packaging.

Does the UDI replace the registration number?

In our reading, no: the UDI identifies the device, while registration or notification is the product's regularization at Anvisa. UDI obligations belong to the manufacturer or holder. For the master, the recommendation is to plan a field for the identifier.

Is the open data file enough to block an item?

It serves for bulk matching and for building the queues. Before blocking, merging or changing supplier, confirm the item in Anvisa's official product search and record who decided.

Who approves merging duplicate codes?

Our recommendation is that the master data team builds the candidate list and procurement approves it with the area that uses the item: pharmacy or nursing for consumables, the operating room or sterile processing for OPME. If there is a regulatory question, regulatory affairs comes in first.

Does OPME need more attributes than other materials?

The Ministry of Health's OPME good practice manual recommends that the master include family or system, model, identification of each model or part, registration and its validity, class with rule, holder and country of manufacture. It is a good practice recommendation, not a regulation.

How 4MDG can help

4MDG does MDM for the healthcare sector, with a single master for medicines, hospital items, suppliers and service providers, regulatory attributes and an audit trail. In the healthcare and pharmaceutical vertical, the work runs from assessment to taxonomy with Anvisa regulatory attributes where applicable, cleansing, deduplication and enrichment against official sources, integration with Tasy, MV and other systems, and ongoing governance. It builds on our material master data cleansing service, with descriptions based on a PDM, NCM and UNSPSC classification, normalized units of measure and packaging, and deduplication with scoring and survivorship. To see where your base stands, request the free assessment or reach us through the contact page.

Disclaimer: this article is operational guidance on master data, not regulatory or legal advice. Brazilian rules and official databases may change. Confirm decisions with your company's responsible technician or regulatory affairs team before applying them.

Sources

Have a question or want to talk about this?

Talk to a 4MDG specialist — we reply through the channel you prefer.

The international code is added when you save.

Message on WhatsApp