INNOVAMED obtains GMP certification from ANVISA (BRAZIL)

GMP Certification granted by ANVISA

INNOVAMED has obtained the Good Manufacturing Practices (GMP) certification for medical devices, granted by the Agência Nacional de Vigilância Sanitária (ANVISA) of Brazil.
 

The certification, published in the Diário Oficial da União through Resolução RE nº 3.110 of 18/08/2025, confirms that our facilities in Barberà del Vallès (Barcelona, Spain) comply with international requirements of quality, safety and regulatory compliance for the manufacturing of Class III and IV medical devices.
 

Prior to the granting of this certification, INNOVAMED successfully passed an on-site audit conducted by the Brazilian health authority, validating the robustness of our manufacturing processes and their conformity with the highest quality standards required by ANVISA.
 

This recognition, valid until 18/08/2027, reinforces INNOVAMED’s position as a leading European manufacturer in the medical device sector.

Full manufacturing in ISO-7 cleanroom

At our facilities we carry out the complete manufacturing of medical devices in ISO-7 cleanroom, including plastic injection molding, assembly, blistering, packaging and all process validations required in such a highly regulated and demanding sector as the medtech industry.
 

Our processes are developed under the strictest standards of GMP, ISO 13485 and ISO-7 cleanroom operations, ensuring our clients maximum reliability, traceability and regulatory compliance.

Supporting our clients towards global commercialization

At INNOVAMED we believe that innovation in medical device manufacturing goes beyond the production process. We accompany our clients on their path to the global commercialization of their medical devices, helping them to meet international regulatory requirements and facilitating their access to strategic markets.

Commitment to excellence in Contract Manufacturing Organisation (CMO)

This new milestone reflects our strong commitment to excellence in medical device contract manufacturing services and to the development of solutions that support our clients in their growth and international expansion.