Compulsory Certification & Foreign Markets
Products under compulsory certification need a certification body before they reach the market. We handle the interface with those bodies (those accredited by INMETRO, those designated by ANATEL and those of other mandatory certifications) and help build the technical documents.
- Company stage
- Enable
Certification and foreign market fronts.
Several regulations may apply to the same product. The work starts by identifying which ones do.
Regulatory mapping
Identification of the regulations and technical requirements applicable to the product.
- INMETRO regulations
- ANATEL requirements
- Other compulsory certifications
Medical equipment
Equipment under health surveillance requires an INMETRO certificate of conformity, kept valid throughout the ANVISA registration or notification.
- Compulsory INMETRO certification
- Certificate valid during registration
Telecommunications
Certification is carried out by a Designated Certification Body (OCD) and approval (homologation) is granted by ANATEL.
- Certification by the OCD
- ANATEL homologation
Technical documentation
Support in building the technical documents the body requires.
- Technical documents
- Evidence of conformity
Liaison with the body
Follow-up of the process with the body until the certificate is issued.
- Communication with the body
- Handling of open issues
- Certificate issuance
Foreign markets
Technical and regulatory documents for the Brazilian product in other markets and the interface with the certification bodies at the destination.
- Documents for other markets
- Certification bodies at the destination
Other services for this stage.
- Company LicensingEnableAFE and AE at ANVISA, establishment registration with MAPA, and licences from health surveillance authorities, the Federal Police, the Army, environmental agencies and municipalities.
- Product RegistrationEnableClassification, dossier and notification or registration of domestic and imported products at ANVISA and MAPA.
- GMP CertificationsEnableAdaptation to Good Practices and preparation for the certification inspection.
Common questions before you start.
Does medical equipment need INMETRO certification before registration?
Equipment under the health surveillance regime is subject to compulsory certification by a certification body accredited by INMETRO and established in Brazil. The certificate is submitted to ANVISA and must be kept up to date throughout the validity of the registration or notification.
What is an OCP?
A product certification body: an entity accredited by INMETRO that assesses the product’s conformity with the applicable technical standards, performs or coordinates testing and issues the certificate. We handle the interface between the manufacturer and the OCP, from documentation to testing.
Do you support exports to other markets?
Yes. We prepare the technical and regulatory documents a Brazilian product needs for other markets, such as the notification or registration certificate for medical devices, and handle the interface with the certification bodies required at the destination.
Last updated: October 2026.
Does your product require compulsory certification?
We identify the regulations that apply to the product and the path to the certificate.