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.<\/p>\n
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\u2019s;\u00a0clinical validations; risk management; usability processes; MED.DEV requirements.<\/p>\n
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.<\/p>\n
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:\u00a0Market Analysis \u2013 Health Regulation in China;\u00a0Product Register in China;\u00a0Audits in conformity with the QMS.<\/p>\n
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.<\/p>\n
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 (Secretar\u00eda de Salud), responsible for product supervision. Our specialists are ready to open the doors of Mexico for your business.<\/p>\n
INVIMA(National Institute of Medicines and Food Surveillance) is Colombia\u2019s 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.<\/p>\n
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.<\/p>\n<\/div>
DIGEMID \u2013 Peru<\/h3>\n
Direcci\u00f3n 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.<\/p>\n
DRPIS \u2013 Costa Rica<\/h3>\n
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.<\/p>\n
ANMAT \u2013 Argentina<\/h3>\n
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 \u2013 ANMAT.<\/p>\n
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.<\/p>\n
ISPCH\u00a0\u2013 Chile<\/h3>\n
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.<\/p>\n
We offer the following services for medical devices in Chilean.<\/p>\n
DNVS \u2013 Paraguay<\/h3>\n
Providing each client with the necessary information for registering products according to their classification before the National Directorate of Health Surveillance (DNVS).<\/p>\n
MSP \u2013 Uruguay<\/h3>\n
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.<\/p>\n
AGEMED \u2013 Bolivia<\/h3>\n
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.<\/p>\n<\/div>
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.<\/p>\n
Contact us for more information about to how obtain your international certifications in LATAM<\/a><\/strong><\/p>\n<\/div>
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