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Medical device registration in Brazil

Medical Device Registration at ANVISA in Brazil

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Regulation of Medical Device in Brazil

Brazil is a biggest Latin American country with population of over 200 Mio. residents. The medical device market has an attractive potential, however with complex regulatory requirements. Brazil's current medical device market worth is approximately $10.5 billion and imported medical devices account for 80 percen t of the market ( Meddeviceonline ).

The authority of medical device is Agência Nacional de Vigilância Sanitária (ANVISA) . Besides monitoring medical device , ANVISA is also responsible for Pesticides, Food, Cosmetics, Pharmacies and Drugstores, Pharmaceutical supplies, Medicines, Ports, Airports and Borders, Sanitarians, Blood, Tissues and Organs, Tabaco.

The main task of ANVISA is to promote the protection of the population’s health by executing sanitary control of the production, marketing and use of products and services subject to health regulation, including related environments, processes, ingredients and technologies, as well as the control in ports, airports and borders.

Actually ANVISA keeps the Brazilian regulatory framework up-to-date at international level. In 2012 it co-founded the International Medical Device Regulators Forum (IMDRF) .

The most important legislatives are listed below:

•Law No. 6360/1976
•Decree No. 8077/2013, DECRETO - Health Surveillance
•Decree No. 79.094/1977, Classification and Registration Requirements for Medical Products
•RDC 751/2022 (replacing RDC 185/2021), Medical Device Registration
•RDC 211/2018, GMP for manufacturers of Medical Devices Resolution
•RDC 665/2022 (Replacing RDC RDC 16/2013), GMP Requirements for Medical Devices and IVDs
•RDC 40/2015, Cadastro Registration Requirements of Medical Devices
•RDC 687/2022 (replacing RDC 183/2017), Administrative processes applicable for granting GMP Certification for manufacturers of Medical Devices (Risk Classes III and IV)
•RDC 56/2001, Safety and Efficacy Requirements
•RDC 67/2009 and Resolution RDC 23/11, Post market surveillance

Prerequiste of Product Registration at ANVISA

The home country approval is not needed for medical device registration at ANVISA. However, the approval in EU, US, Japan, Australia and Canada can leverage the review process by Brazilian authority.

You need a Brazilian agent who has a business licence in Brazil and communicates with ANVISA in Portuguese.

Then you have to achieve Brazil Good Manufacturing Practice (GMP Certification) in prior to product registration of class III and IV medical device. Please be aware that the MDSAP certificate acts as only a good reference to accelerate GMP CERTIFICATION approval, however it doesn’t replace it.

Brazilian agent

It is also called Brazilian Registration Holder (BRH). The role is very similar to US agent and Chinese agent of medical device and IVD.

To simplify sales activities of medical device in Brazil, an excellent solution is the hosting of registration with help of BRH. With Hosting Service, your company could submit product dossier benefiting sound regulatory affairs experience, without establishing a subsidiary in Brazil and get all licenses required by ANVISA. It also reduces time and cost without binding often to economic oriented distributors as BRH.

With hosting service, product registration will be issued on behalf of a third consulting party that has no sales activity, but only hosts registration and provides an import authorization for any distributors designated by manufacturers.

With hosting service, the manufacturers will have full control over product technical documents, so host is just a third contracted part because the rights are contractually limited to manufacturer.

The Brazilian Registration Holder will be responsible for maintaining the registration during its life time, and the manufacturers and its appointed distributors will have exclusive use of this record and service.

Product classification

In accordance with RDC 751/2022 chapter II there are there are four classes of medical device in Brazil, I, II, III and IV (see Table 1). Very similar to Annex VIII Classification rules at MDR in Europe there are 22 classification rules pursuant to RDC 751/2022 in Brazil. Brazilian class I and IV medical device can be equivalently respectively seen as European class I and III under rough comparison. And Brazilian class II and III medical device corresponds to European class IIa and IIb.

If medical device manufacturers are unsure about classification, a system to apply for determination of classification of medical device can be used at ANVISA.

Notificação means abbreviated registration. It applied to class I and II medical device. From class III to IV there is a more complex registration process called Registro with more documents, GMP certification and often other certifications.

Medical device classification	Type of registration
I	Notificação (Notification)
II	Notificação (Notification)
III	Registro (Registration)
IV	Registro (Registration)

Table 1: Classification and type of registration of medical device in Brazil

The product certificate of class I and II medical device doesn’t expire. The product certificate of class III and IV medical device is 10 years valid in Brazil.

Registration process of Medical Device in Brazil

Based on product classification the following registration process is illustrated:

Registration process of medical device in Brasil

At the beginning in accordance to classification rules, the product class should be defined, followed by a gap analysis fulfilling prerequisite of registration and checking existing documents depending on type of registration. For class III and IV medical device a GMP certification must be applicatd. If necessary, testing of INMETRO and ANATEL should be planned in time. After compilation of documents, the dossier in Portuguese will be submitted. The submission of documents to ANVISA must be made in electronic format through ANVISA‘s Electronic Petitioning System.

The second obstacle after documents and testing preparation is efficient reply by legal manufacturers in written upon authority’s deficiency request. With organised and strategic product registration there is no wonder of successful product approval at the end.

Cost and time

ANVISA fees for Medical Devices:

Class I and II (Low risk): About USD 190,00
Class III and IV (High Risk): About USD 890,00
GMP Certification: About USD 25.890,00

Time of ANVISA review (After submission)and testing:

Class I: 15 days
Class II: About 2 months
Class III and IV: 4 - 5 months
GMP Certification: About 8 months.
On demand reply by deficiency request: 120 working days
INMETRO certificate: 4 - 6 months
ANATEL certificate: 4 - 6 months

Document at a glance

GMP Certification:

Manufacturing site: Total area, Area of the productive sector, Total number of employees, Number of employees in the production area and in the quality area;
Quality Manual;
List of all products manufactured on site;
Production flowchart
Audit report

INMETRO Certification:

Quality Manual
Risk management
Usability test report
List of critical components
Customer Complaints
Packaging and labelling info
Validation of software
Electric schematics, diagram of isolation regarding electronic medical device

What about the requirements of technicial dokumentation (RDC 751/2022)?

Technical dokumentation of medical device in Brasil

Some additional certifications

1. GMP Certification

GMP certification is one additional pre-step among registration process of medical device in Brazil. It applies only class III and IV medical device.

Requirements of GMP certification are very similar to 21 CFR 820 at FDA in US according to RDC 16/2013 whose precursor RDC 59/2000 was more or less pure translation of 21 CFR 820.

The GMP certification is 2 years valid. After the first 2 years GMP Certification, overseas manufacturer should provide a self-inspection. After an assessment based on documental analysis (audit report within the scope of ISO 13485 and MDSAP), ANVISA would grant a GMP certification instead of a re-inspection on site of overseas manufacturers.

If the overseas manufacturers have MDSAP certifiate, it can facilitate obtaining of GMP Certification. It doesn’t mean that with MDSAP certificate it automatically complies with requirements of GMP Certification in Brazil!

2. INMETRO certificate

INMETRO certification is not only required for electro medical devices subject to IEC 60601, but also in scope of norms below with which medical device has to conform:

ISO 6875:1998: Dental patient chair
ISO 7785-1:1999: Dental handpieces – Part 1: High-speed air turbine handpieces
ISO 7785-2:2004: Dental handpieces – Part 2: Straight and geared angle handpieces
ISO 9680:2001: Dentistry - Operating lights
ISO 9919:1997: Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
ISO 11195:2000: Gas mixers for medical use – Stand-alone gas mixers
ISO 8835-2:2010: Inhalational anaesthesia systems – Part 2: Anaesthetic breathing systems
IEC 61689:1998: Ultrasonics – Physiotherapy systems – Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz.

The National Institute of Metrology, Standardization and Industrial Quality mandates accredited Certification Bodies (OCP/CB) to conduct certification.

Testing for electro-medical products performed outside Brazil is usually accepted. This option totally saves the cost and time instead of sending medical device to Brazil. After product approval by ANVISA, the medical device must bear an INMETRO mark as a label. The Inmetro certificate is 5 years valid.

NEW! Under Ordinance No. 384/2020 the inmetro certificate will NOT expire.

The workflow of INMETRO certification:

Inmetro Process of medical device in Brasil

3. ANATEl certificate

The Agência Nacional de Telecomunicações (ANATEL) certificate applies medical device with telecommunication using use radio frequency (RF) spectrum or wireless communication, e.g. Bluetooth, Wi-Fi, etc.

For this certification it is like Chinese Type Testing at which the device has to be send to Brazil for testing.

Summary

The medical device registration in Brazil is not preconditioned with home country approval. It is ideally that legal manufacturer has a certificated QM system (ISO 13485 or 21 QSR 820) for register III/IV medical device.

Compared to other country`s official fee to register medical device, ANVISA fee remains quite attractive also under consideration that product certificate is 10 years valid.

For some electric medical devices or medical device with radio frequency (RF) spectrum or wireless communication it is of course indispensable to receive INMETRO and ANATEL certification.

Fortunately the submission dossier to ANNISA is mainly based on EU or US technical file which legal manufacturers don`t need to re-generate additionally, but only translate it in Portuguese.

With calculable review time of technical file by ANVISA and structured maintenance inspection of above mentioned certifications, Brazil is still an absolute worthy medical device market to enter.

Então vamos!

Contact us to network elite of international regulatory affairs. We can support you as well in term of project in your team.

Registration of medical device in Taiwan

Taiwan is not huge in term of geography however one of the important market in Asia for most manufacturer. The market size was 2.7 billion $ in 2021 with 3% grow rate. Overseas manufacturer should not ignore Taiwan market with moderate registration demand, awareness of heath and an increased aging population.

There is predicate cost and time at site of authority. The language of submission dossier is in English. Taiwan registration has some Asian characters in term of structure of authority, legislative, however from the art of classification of products and quality management they are very western. For example for some of notified body in EU, Taiwan is a critical part at MDSAP inspection. So better to have a compliant Taiwanese QM and prepare technical documentation for product registration with same emphasis.

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International registration of medical device

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It makes headache for manufacturer of medical device, to go from MDR to FDA in US, ANVISA in Brazil or NMPA in China or conversely. Depending on ease of changing regulation, every market can be primary important, only if you understand the technical documentation as basis and country specific requirements.

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