As the largest country in Latin America, Brazil has the strongest economy and the largest market for medical products. Despite many national and multinational medical device manufacturers, more than 10% of the products are imported. The country especially depends on the import of high-tech medical products. After the USA and ahead of China, Germany is one of the countries from which most medical products are imported.

The classification is carried out according to 18 classification rules, which are laid down in Brazil by RDC 185/2001. These are comparable with the classification rules of the Medical Device Directive 93/42 EEC. However, medical devices in Brazil are classified in Classes I, II, III and IV.

Approval Procedure

To obtain approval for a medical device on the Brazilian market, the following steps must be carried out.

Step 1: Naming the license holder
A designated Brazilian licence holder or distributor is a prerequisite for authorisation in Brazil. This is also the contact person for Anvisa.

Step 2: Product family and approval
A product family requires only one approval and can be supplemented later with further products. Therefore, in order to reduce the effort, it should be analyzed whether several products can be approved as a product family.

Step 3: Accessories and components
In many cases, accessories do not require their own approval and can be approved together with the medical device.

Step 4: Inmetro certificate for medical electrical equipment
ANVISA established by Decision RDC 27/11 that the approval requires proof of the safety of medical electrical devices. In addition to product testing, the manufacturer’s quality management system is also audited by a certification body recognized in Brazil. The Anvisa can be proven by the national Inmetro certificate issued by the certification body that these medical products meet the safety requirements of the IEC 60601 series of standards.

Step 5: BPFC certificate for approvals according to the „registro“ procedure
BPFC means Boas Práticas de Fabricação e Controle – or good manufacturing and control practices. For products with a higher risk class, Anvisa has been conducting international audits of medical device production facilities since 2010. This is intended to ensure that the quality management system also complies with Brazilian legislation RDC 16:2013.
Since 2017 it is also possible to obtain the BPFC certificate by analyzing the MDSAP report or an audit report, which is recognized for approval by an IMDRF member state.

Step 6: Technical documentation and evidence
Depending on the approval procedure, elaborate documentation must be submitted with the application for approval. These, as well as the instructions for use, must be in Portuguese. An economic information report is also required for certain medical products.

Step 7: Application by the licence holder
The forms completed and signed by the licence holder must be submitted to the visa office together with the technical documentation and any necessary documents.

Step 8: Application processing Anvisa
The application for approval will be examined by the relevant department. With a protocol number, the current status of the process can be tracked electronically. If, for example, documents or information are missing, they are requested, and the process is stopped.

Step 9: Public publication of the approval
The authorization or refusal shall be published in the Official Journal of the Government and shall become final only thereafter.

Step 10: Renewal of approval
When the approval is granted, the medical device is approved for a period of ten years. This applies to products that have been approved according to the „registro“ approval procedure. An application for renewal must be submitted about twelve months before the authorization expires.

Approvals according to the „notificação“ and „cadastro“ procedures do not have to be renewed.

Approval Process

The „Notificação“ approval procedure introduced in 2019 is used for medical products of risk class I. The approval is granted automatically 30 days after submission of the application and payment of the approval fee.

The simplified „Cadastro“ approval procedure is used for products of risk class II. Before the approval is granted, the approval application and parts of the technical documentation are analyzed by ANVISA.

For medical devices in higher risk classes, the more complex „Registro“ approval procedure must be carried out. In addition to detailed technical documentation, a BPFC certificate is required. This certificate is issued after a successful audit by ANVISA or after an accredited audit report.

The Asian market offers manufacturers of medical devices a huge sales market and opens great opportunities. For many manufacturers, however, the approval of a medical device in Asia is an almost insurmountable process. Asian approvals cost manufacturers a lot of money, time and an enormous amount of research, as the Asian economic area is only in the early stages of regulation.

NSF International will help you with this difficult procedure.

Since 1 April 2000, the „Regulations for the Supervision and Administration of Medical Devices“ have entered into force. The SAMR (State Administration for Market Regulation) was established as a monitoring body for medical products. The SAMR has high expectations of overseas manufacturers and demands enormous administrative effort for product approval. It is responsible for all imported products of classes I, II and III. An agent in China who works for them is responsible for the approval of their product.
NSF International advises you in all questions concerning the approval of your product in China, including the preparation of a specific clinical evaluation.

Technical Documentation
The Chinese market is one of the most difficult markets for the approval of medical products. On the one hand, language barriers are the reason for the difficult approval, on the other hand, the not yet fully regulated environment with many regulations in the Chinese language.

The monitoring by the SAMR (State Administration for Market Regulation) is very strict and often overstrains the manufacturers of medical products. The technical documentation (STED) of all imported products (Class I, II and III) is controlled by the NMPA (National Medical Products Administration). Depending on the product class, various tests are also carried out in Chinese test laboratories.

The necessary scope of the technical documentation delivered to NMPA is decisive for a smooth process. Furthermore, it enables a timely registration and saves the manufacturer an increase of further cost of translating documents and content into Chinese. In the interests of the manufacturer, not too much product information should be disclosed, but not too little either.

Benefit from our experience in compiling the technical documentation required for registration. NSF International records the regulatory requirements for your products and identifies the Chinese standards to be applied and the differences or similarities with the EU standards you are applying. NSF International then adapts its technical documentation to the specifications of the Chinese authorities and agrees with you on the optimum level of detail.

Product Registration
Manufacturers who decide to export to China are often faced with problems regarding the content and procedures of the registration application. The NMPA (National Medical Products Administration), like other authorities, requires many documents and statements for a complete registration file. The already time-consuming registration process can be unnecessarily prolonged by missing registration documents. In addition, there is the fact that many detailed requirements can lead to problems that are difficult to predict.

NSF International helps you to compile the registration documents and accompanies you on the way to the registration of your product in China.

The market for medical devices in Canada is monitored by Health Canada. It is comparable to the Food and Drug Administration (FDA) in the USA or ANVISA in Brazil. Medical devices are classified into risk classes I, II, III and IV according to CMDR (Canadian Medical Device Regulation). The scope of the regulatory requirements for the manufacturer depends on the product classification.

If your company is not represented in Canada itself, you need a local representative who is available for you as your national contact for Health Canada. Medical devices must also be registered at Health Canada. In addition, you will need various documents for your medical device for successful approval. These include the intended use, the risk management file, the clinical evaluation, the instructions for use and a corresponding declaration of conformity.

Except for some low-risk medical devices, you must obtain a license for your product from Health Canada on the Canadian market. For Class II and higher products, you will also need a quality management system that meets the requirements of ISO 13485.

Certification in accordance with the MDSAP program has been mandatory since January 1, 2019. The preparation for a corresponding audit is time-consuming and cost-intensive and represents a major challenge for companies. NSF International can also actively support you here and provide you with extensive expertise. Further information can be found here, for example.

After successful registration of the products, they will be listed in the „MDALL (Medical Devices Active License Listing)“ database. Here you can also search for already approved products.

NSF International accompanies you on your way to the successful approval of your medical device for the Canadian market. Starting with the product classification and the search for a domestic representative in Canada, through the compilation of technical documentation, the implementation of a quality management system, to the necessary post-market surveillance activities after the successful approval of your medical device, we support and accompany you.