Project Description

  • international ceritification and licenses

CE Certification and FDA Registration with Passarini

Passarini International Licenses and Certification

Exporting is one of the best ways for companies to grow and achieve sustainability. Passarini Regulatory Affairs, boasts of extensive experience in CE marking services having successfully facilitated one of the first CE certifications of Brazilian medical equipment in the EU.  In addition to effective collaboration with the main global regulatory agencies, our CE certification services involve providing assistance to your company throughout the entire regulatory process.

Which International Agencies does Passarini Work With?

If you are looking to commercializing products in Latin America, the United States, and Europe, we offer custom solutions that meet your specific needs. 

Some of the main global product regulation agencies we work with are:

  • FDA 
  • CE 
  • COFEPRIS 
  • DIGEMID 
  • INVIMA 
  • ARCSA

Check below the best way to start the growth of your company through the regularization of each country:

FDA – United States

For FDA approval, Passarini provides a team of specialists trained in a variety of subjects related to consulting and advisory services with the US Food and Drug Administration body.  In addition to Portuguese-English translation services, we offer the best market rates when it comes to FDA registration services.

To check out a list of companies that are FDA approved through Passarini RA, click here.

CE Marking – Europe

Our CE Marking Services ensure your products are viable in Europe, which is crucial to opening several doors for your company to grow and earn a market presence in the region.

Passarini Regulatory Affairs is able to prepare your Technical File regardless of risk class and with CE certification specialists that boast extensive experience in the European Union’s;

  • clinical validations
  • risk management
  • usability processes 
  • MED.DEV requirements 

With our CE certification services, you get the necessary product testing, training of your team, and assistance in the creation of European representation. Furthermore, we also assist in the selection of qualified, agile, and cost-effective certifiers for your project.

COFEPRIS – Mexico

If your company intends to introduce a new product in Mexico, you must be compliant with the regulatory requirements established by COFEPRIS, an internal division of the Mexican Ministry of Health (Secretaría de Salud), responsible for product supervision. Our specialists are ready to open the doors of Mexico for your business. 

DIGEMID – PERU

Dirección General de Medicamentos, Drogas y Insumos (DIGEMID), is a unit of the Peruvian Ministry of Health responsible for the certification of products in the country. Peru is experiencing significant growth, which is also increasing the demand for imports. It is advisable to consider Peru as one of the exciting markets to which you can export your products.  

INVIMA – Colombia

INVIMA(National Institute of Medicines and Food Surveillance) is Colombia’s regulatory body for the medical devices market. Passarini Regulatory Affairs works with consultants specialized in INVIMA to help you register any product in the country.

ARCSA – Ecuador

ARCSA (National Agency for Regulation, Control, and Sanitary Surveillance) is the regulatory body for the medical devices market in Ecuador. You can count on our experts to help you explore this market by helping you get your products certified.

Bring your project to Passarini Regulatory Affairs and we will help you create the best value proposition to drive your company growth, and introduce your products to not only European and American markets but also to other countries in Latin America.

For information about our services, contact us! 

You may also be interested in: 

> INMETRO Certification

> ANATEL Certification

> ANVISA Notification and Records

> Quality Management Systems

Process validation 

European Representation

> International Licences

> Risk Assessment

> CE Bookmark

> ANVISA PMV

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