Exporting is one of the best ways for companies to grow and achieve sustainability. Passarini Group, 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, AGEMED, ISPCH, MSP, DRPIS, ANMAT, CFDA, PMDA e DNVS
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 – 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.
CFDA – China
If your company have an interest in commercializing products in China we have the ideal solution. Check below all the services we perform for this market: Market Analysis – Health Regulation in China; Product Register in China; Audits in conformity with the QMS.
PMDA – Japão
Passarini Group with office in Tokyo can provide you with full assistance in preparing the application for the Foreign Manufacturer Certification which is registered with the PMDA by the MAH, and we can submit this application even if you have named Passarini Group as your D-MAH.
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.
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.
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.
DRPIS – Costa Rica
Our office offers the Sanitary Registration service, with a team of specialists who can provide exclusive assistance for your needs in the Costa Rican market, such as: Medicines; Medical Devices; Foods and drinks; Cosmetic and Hygienic Products and Route Changes.
ANMAT – Argentina
Manufacturers of medical products wishing to register their products in Argentina must comply with the requirements of the National Administration of Medicines, Foods and Medical Technology – ANMAT.
Passarini Group is a company that has the best specialists in Regulatory Consultancy of Medical Products, applying the One Stop Shop concept daily in your company with practical solutions.
ISPCH – Chile
The current regulatory model establishes that there are 9 medical devices for which health registration with the ISPCH is required, which will allow their distribution, commercialization and/or use.
We offer the following services for medical devices in Chilean.
DNVS – Paraguay
Providing each client with the necessary information for registering products according to their classification before the National Directorate of Health Surveillance (DNVS).
MSP – Uruguay
Passarini Group, through its technical team in Uruguay, offers the comprehensive advice and support you need to comply with the regulatory framework in all its stages.
AGEMED – Bolivia
In addition to obtaining different international certifications, Customs Clearance, Current Business Certificate, Good Storage Practices Certificates, Regular Inspection Certificates issued by the Regulatory Entity of Bolivia AGEMED (State Agency for Medicines and Health Technology), we have trained and technologically updated personnel using a modern system that facilitates and streamlines our processes.
Bring your project to Passarini Group 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.
Contact us for more information about to how obtain your international certifications in LATAM