INMETRO and ANATEL certification: A requirement for authorization in Brazil?

When ANVISA registration is no longer sufficient

As a manufacturer, there are some hurdles you have to overcome before selling your medical device in Brazil. The best known is registration with ANVISA. In addition to this, you may also need INMETRO or ANATEL certification for your device.

Manufacturers should be aware of the cases in which they must present INMETRO or ANTEL certification and fulfill further requirements. Otherwise, there is a risk of unpleasant surprises during the authorization process, which may be delayed and incur unplanned costs.

In this article you will learn,

• under which circumstances, which authorities other than ANVISA will inspect your devices and
• how to schedule the necessary tests.

1. INMETRO and ANATEL certificates as part of the authorization documents

Some devices can only be marketed in Brazil with INMETRO or ANATEL certification. These two authorities are responsible for testing and certification.

Manufacturers may only apply to ANVISA for registration of such medical devices if they can present an INMETRO or ANATEL certificate. These certificates must be submitted to ANVISA along with the device documentation.

2. INMETRO certification

a) Who INMETRO is

INMETRO is the National Institute of Metrology Standardization and Industrial Quality. The authority is not only responsible for medical devices, but also, more generally, for products that contribute towards the safety and – as in the case of medical devices – the health of people. So, in addition to medical devices, it is responsible for products such as domestic appliances, wheels, tires, and lights.

Its inspection ensures that products meet defined minimum standards. Typically, these are national versions of international standards, such as ABNT NBR IEC 60601-1:2010 + Emenda 1:2016 or ABNT NBR IEC 60601-1-2:2017.

The requirements for the INMETRO certification are defined in Resolution 384/2020. However, not every medical device is subject to inspection by INMETRO.

b) Which devices are affected

Medical devices that require an INMETRO certificate include:

• electrical devices
• sterile single-use syringes
• breast implants
• surgical and non-surgical rubber gloves
• condoms

The complete list of products, most of which are not medical devices, can be found here. 

c) How to obtain an INMETRO certificate

Choosing a suitable certification body

The inspection and issuing of the corresponding certificate can be done by INMETRO itself or by a body recognized by INMETRO.

To apply for certification, you need to have a Brazilian company as an authorized representative. This means that if you do not have an office in Brazil, you will need a Brazilian certificate holder. This is where your authorization partner comes in, with whom you are planning the ANVISA registration. This local partner should be able to help you select a suitable certification body.

The certification itself consists of two parts:

1. Device inspection, including a check of the technical documentation
2. Audit of the manufacturer and the Brazilian INMETRO certificate holder

Certification (part 1): Device inspection

For the device inspection, the following documents, among others, have to be submitted:

• risk management file
• usability engineering file
• documentation of applicable QM and manufacturing processes
• test reports (if available)

If your device has already been inspected, it is possible to use existing test reports for the INMETRO certification. You should agree on the exact requirements with your certification body.

Test reports that meet the following conditions are often accepted:  

• The report represents the current technical state of the device.
• It was written by an ILAC-certified body.
• It has been checked against the standards (and versions) recognized by INMETRO and ANVISA.

ILAC is an international association of accreditation bodies that includes, for example, the German DAkkS.

You can find a list of INMETRO accredited bodies on the INMETRO website.

Comment:

The recognized standards (versions) are listed in the normative instructions (Instrução Normativa):

• IN 29/2018
• IN 22/2017
• IN 4/2015

If you do not yet have test reports, your device will be tested for the INMETRO certification. This can extend the certification process, and the certification costs will increase accordingly.

Certification (part 2): Audits

The focus of the audits is on verifying compliance with the INMETRO requirements. These include requirements for the QM system according to ISO 13485 (e.g., design and development, production) and requirements for 100% testing (e.g., leakage current or earthing according to IEC 60601-1).

The Brazilian certificate holder also has to be audited and, similar to the manufacturer audits, the focus is on auditing certain ISO 13485 criteria (including document control, non-conforming devices, corrective actions).

d) How long the INMETRO certification process takes and what it costs

INMETRO certification can take several months. Since December 2020, the certificates issued are valid indefinitely as long as you undergo audits to confirm that it is maintained.

You should budget for costs of between USD 2,500 and USD 5,000 for the maintenance of the certificate. In addition to this, there are the costs of your local certificate holder.

The exact cost of the INMETRO certification depends on the corresponding certification body and the tests to be performed. Brazilian bodies often offer low-cost certification. However, they then work with auditors in the manufacturer’s home country, which means prices can vary from country to country.

3. ANATEL certification

a) Who ANATEL is

ANATEL is the Brazilian national telecommunications authority. It demands that all telecommunications products sold in Brazil have a certificate of conformity. This obligation also applies to corresponding medical devices. As a result, an ANATEL certificate must be submitted to ANVISA for these devices.

As with the INMETRO certificate, whether an ANATEL certificate has to be submitted or not does not depend on the device class: manufacturers also need an ANATEL certificate for certain class I devices.

The general requirements for ANATEL certification are defined in Resolution 715/2019.

b) Which devices are affected

All devices that have a radio module require ANATEL certification. This applies, for example, to devices with a Bluetooth or WiFi interface.

The devices affected have to undergo a conformity assessment procedure. This includes device testing in Brazil and an inspection of the technical documentation.

c) How to obtain an ANATEL certificate

Various stakeholders are involved in the certification process:

• the manufacturer of the medical device
• a local representative (REP) in Brazil
• a test laboratory
• a certification body (OCD)
• ANATEL

As first step, a manufacturer without an office in Brazil has to contract a local representative (REP), as only Brazilian companies can apply for ANATEL certification. 

Together with the manufacturer, the local representative contracts a certification body, known as an OCD (Organismo de Certificação Designado). The OCD is responsible for identifying the standards that have to be complied with and the tests required.

To do this, it receives technical device information from the manufacturer, e.g.,:

• specifications
• drawings
• device labels

You can find a list of OCDs recognized by ANATEL on the ANATEL website.

The local representative then contracts a test laboratory to carry out the necessary device testing.

Once the tests have been completed, the OCD checks the available test reports, issues a certificate of conformity, and forwards the data to ANATEL.

In the last step, ANATEL checks the data sent and issues a certificate of homologation if the requirements have been met. This ANATEL certificate is necessary for device authorization with ANVISA.

d) How long the ANATEL certification process takes and what it costs

The costs and duration of the certification depends largely on the following factors:

• availability of test laboratories
• test effort
• technology to be tested

For example, testing a device that has a Bluetooth 2.0 interface is less time-consuming and costly than testing a device with 4G technology.

Manufacturers should estimate approximately six months for the entire certification process. The process includes the device inspection, which can take up to three months, and the subsequent issuing of the “certificate of homologation.”

This ANATEL certificate of homologation is valid indefinitely. However, the OCD must monitor the certificates it issues. So, an inspection of the documentation by the OCD is required every 24 months in order to maintain the ANATEL certificate and, as a result, the ANVISA device authorization. During this inspection, the OCD checks whether the specifications have remained the same or have changed. When requirements change, the OCD checks whether the certificates it has issued are still valid. In this case, the technical documentation also has to be submitted. A new test may be required if the device has been modified.

4. Conclusion

For some devices, you, as the manufacturer, must meet specific requirements and present an INMETRO and ANATEL certificate. Nevertheless, the hurdles for device approval in Brazil are not insurmountable. For this authorization, you, as a foreign manufacturer, need a local representative. Therefore, their careful selection is the most important prerequisite for a successful authorization.

You can successfully plan and implement your authorization if you also ensure compliance with all applicable requirements and know the certification costs.