Certification of conformity INMETRO
The health legislation in Brazil determines for manufacturers and importers of electromedical devices that wish to register their products in the country, the need to present at the ceremony of the registration request of the compliance certification which ensure that the product meets the technical standards issued by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO).
The Passarini Regulatory Affairs team can assistant your company in the certification with the INMETRO, including paying all the advisement for execution of tests and subsequent approval.
As part of our consulting services of the INMETRO certification, we can assist you as follows:
- Selection of certifying bodies and laboratories;
- We provide the entire advisement working directly with the INMETRO or Certifier (depending on the type of certification);
- We accompany tests, suggesting adjustments in the projects and product documentation (manuals, labelling, packaging, etc.), assembling the required documentation (risk analysis, validations, including the new standards of the family IEC 60601);
- For imported products, we maintain contact with manufacturers and laboratories, lifting up all the necessary documentation and providing all the assistance to solve the doubts;
- Biocompatibility: selection of tests, quote of laboratory and accompaniment of the tests;
- Risk analysis: we assemble the whole process of risk analysis and we train the staff;
- Clinical validation: we assemble the clinic validation process by similarity (literature) and historic (can be used for CE certification);
- Usability: we assemble the whole process of risk analysis and we train the staff;
- Software validation: we assemble the whole process of risk analysis and we train the staff;
- Products adequacy to the electrical safety standards;
- Adequacy of products to the electromagnetic compatibility standards
- INMETRO certification to materials, as for example, mammary prosthesis.
The ANVISA accepts certifications for electrical safety of foreign tests agencies, if performed by certified laboratories by the International Laboratory Accreditation Cooperation (ILAC).
