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For commercialisation of electrical medical products in the Brazilian market, the national health surveillance agency ANVISA requires certification as part of the requirements prior to granting registration. The marking obtained by this process is given by CGCRE – General Coordination for Accreditation of INMETRO (the National Institute of Metrology, Standardization and Industrial Quality) via accredited bodies. The INMETRO seal is mandatory and guarantees the quality, safety and efficacy of marketed products in the country.

Meet Regulatory Requirements For Medical Devices

It is important to know that the reasoning for the certification process is intended primarily to inform and protect consumers, particularly with regard to health, safety and the environment. In addition, the product certification seeks to promote fair competition between the manufacturers and encourage continuous quality improvements in products. Globally, the certification provides adequate control with regards to international trade, while at the same time strengthening Brazil’s internal market.

How Does ANVISA Define Medical Devices?

ANVISA defines medical devices as appliances, materials or accessories whose use or application is related to safeguarding individual or collective health, personal hygiene or cleanliness of surroundings; for diagnostic and analytical purposes; including cosmetic and perfume, as well as dietetic, optical, medical acoustic, odontology, and veterinary products.

Specifically:

  • Diagnostic equipment
  • Therapy equipment
  • Medical-hospital support equipment
  • Disposable materials and devices
  • Implantable materials and devices (certification process not mandatory)
  • Medical-hospital support materials and devices
  • In-vitro diagnostic products (certification process not mandatory)
  • Beauty and aesthetics devices

How Does The Certification Process Works?

Regulatory compliance

Medical devices intended for sale in Brazil must be prior approved by ANVISA and accredited by CGCRE – General Coordination for Accreditation of INMETRO via an approved certification body. ANVISA has developed a set of essential requirements for medical device compliance, similar to those in the EU, which gives two routes to ANVISA approval: i) Cadastre and ii) Registration.

Two routes to approval

i) Cadastre is for lower risk devices, and the simplest and quickest route to approval

ii) Registration is a more complex process

Cadastre and Registration require similar documentation during the approval process.

Approval Process for Cadastre and Registration

The following steps are required to followed:

  • Step 1

    Conduct an ANVISA Good Manufacturing Practice (GMP) audit. The GMP audit is performed directly by ANVISA and must be done before the registration submission, because the GMP certificate issued is a pre-requirement for the registration submission for products class III, IV and some products class I and II (according to the Brazilian regulations). It is necessary to classify the product for registration first to determine if GMP will be required or not.
  • Step 2

    Electromedical devices covered by any standard included in the Normative Instruction No.3 issued by ANVISA must be certified by an CGCRE of INMETRO accredited ‘Organization of Certification of Product’ and display the INMETRO mark.

    This process includes:

    • Initial factory inspection against ISO 13485 plus additional requirements of ORD 350
      Product testing of all INMETRO marked goods conducted by IEC accredited laboratories (accredited by a member of ILAC, IAAC or EA)
    • Product test reports must be no more than two years old for initial certification and repeated at renewal, if the test reports are older than five years
    • Annual surveillance inspections based on ISO 13485 and ORD 350 requirements to ensure standards continue to be met

    Please Note:

    Brazil uses international standards to guide their rules; however, these naturally undergo an adaptation to local requirements. Regarding the transition to the third edition of the series of standards IEC60601-x there is a large commitment from all sectors involved. In 2013 both second edition and third edition test reports of basic electrical medical equipment standard family IEC 60601-X can be applied. It is expected that from 2014 the third edition of the series of standards will be mandatory.
  • Step 3

    Technical documentation is submitted to ANVISA.
  • Step 4

    Approval achieved.

Other Requirements In Addition To The Approval Process

  • Import controls
    Customs agents check medical devices transported to Brazil against the ANVISA database. This is to ensure all medical devices comply with the registration requirements before they are allowed entry into the country.
  • Local representation
    To sell your products in Brazil you must meet the ANVISA approval requirements and have a local representative within Brazil who can act on your behalf in all product-related matters.

Further Information

SGS has more than 70 years experience in the Brazilian market. As an accredited CGCRE – General Coordination for Accreditation of INMETRO certification body, we offer an unrivalled expertise in facilitating market approval for electrical and electronic products classed as medical devices.

Contact the Medical Devices Team today to see how we can help your business. Kindly click on the “Email Us” link on this page.