Brazil and Medical Device Single Audit Program

Brazil is one of the critical countries among Medical Device Single Audit Program (MDSAP) besides US, Canada, Japan and Australian. We want to introduce the complex product registration of medical device below.

1.Knowing 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 percent 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 regulations 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, Medical Device Registration
RDC 211/2018, GMP for manufacturers of Medical Devices Resolution
RDC 665/2022, GMP Requirements for Medical Devices and IVDs
RDC 40/2015, Cadastro Registration Requirements of Medical Devices
RDC 687/2022, 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

2.Chose a 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 your deadline to have sales in Brazil, an excellent option is the hosting of registration with help of BRH. With Hosting Service, your company could submit your product dossier benefiting sound experience of regulatory affairs service, without the need to stablish a subsidiary in Brazil and get all licenses required by ANVISA, reducing time and cost, without binding often only economic oriented distributors as BRH.

With hosting service, your registration will be issued on behalf of a third consulting party that has no sales activity, only hosts registration and provide an import authorization for any distributor designated by the manufacturer.

With hosting, the manufacturer has full control over the record, so host is just a third contracted part because the rights are contractually limited to manufacturer.

The host will be responsible for maintaining the registration during its lifetime, and the manufacturer and its appointed distributors will have exclusive use of this record and service.

3.Product classification

In accordance with RDC 751/2022 chapter II there are four classes of medical device in Brazil: I, II, III and IV. Very similar to MDR Annex VIII Classification rules in Europe there are 22 classification rules pursuant to RDC 751/2022 in Brazil. Brazilian class I and IV medical device can be equivalently 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.

Notification (class I and II) means abbreviated registration. It applied to class I and II medical device. From class I to IV there is a risk-based rising complex registration process called Registro (class III and IV) with demanding documents, GMP CERTIFICATION and often extra certifications.

4.Start Registration

Based on product classification the following registration process is illustrated:

Define product classification
Regulatory strategy (matching of prerequisite and gap analysis of existing documents depending on type of registration)
Prepare GMP Certification(for class III and IV medical device)
Undertake testing for INMETRO and ANATEL certificate, if applicable
Document compilation and submission
Technical review by ANVISA
Reply upon deficiency request
Successful product approval

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 applied. 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 of legal manufacturers upon authority’s deficiency request. With organised and strategic product registration there is no wonder of successful product approval at the end.

Anvisa Certification

This is typical product registration where authority proves the technical documentation. The reference is annex II of RDC 751/2022 with 6 chapters which are aligning the table of content at IMDRF.

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

Estimated time for ANVISA review (After submission):

Class I: 15 days

Class II: About 2 months

Class III and IV: From 4 to 5 months

On demand reply by deficiency request: 120 working days

GMP Certification

GMP certification is one additional and typical 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 751/2022 whose precursor RDC 16/2013 and RDC 59/2000 were 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.

INMETRO certification

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.

The workflow of INMETRO certification:

1. Select a certification body accredited by INMETRO (It must not be in Brazil!)

2. Document analysis by certification body, actual testing report in focus

3. Factory inspection by certification body, QM-documents and testing report of approved product (less than 2 years old) in focus

4. Issue of INMETO mark

5. Placing INMETRO mark as an essential label on device

6. Annual maintenance post-inspection by certification body

ANATEl certificattion

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 sent to Brazil for testing.

Medical Device Single Audit Program (MDSAP)

MDSAP is a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

The program includes these authorities:

Australian Therapeutic Goods Administration (TGA)
Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
Health Canada
Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW/PMDA)
U.S. Food and Drug Administration (FDA)

The cycle of inspection is 3 years with initial-, surveillance and re-certification audit.

In this process underscored audit there are main processes to be inspected

Management
Device marketing authorization and facility registration
Measurement analysis and improvement
Medical devices adverse events and advisory Notice Reporting
Design and development
Production and servicing controls
Purchasing

Please pay attention that MDSAP certification doesn’t exempt additional quality management inspection in Japan and Brazil. However with MDSAP it leverages the inspection in both markets.