Registration Process

Manufacturers need to obtain ANVISA (​ Agência Nacional de Vigilância Sanitária ) approval prior to selling their products in Brazil. Brazil has four classes of IVDs with ascending risk, and two registration pathways: Cadastro and Registro . The Cadastro registration route is for lower risk IVDs, has a simplified application, and typically takes less time than Registro reviews. Download the chart in PDF, or read below for the explanation of the process.

Russia is a promising market for medical devices, but the regulatory process can be challenging. The Russian regulatory authority, Rozsdravnadzor, prioritizes device testing and clinical data to verify device safety and efficacy. In this video, we provide a high level overview of the steps in the Russia medical device registration process, including: Key players in the Russia regulatory system Technical file documentation and language requirements Testing and clinical data requirements Phases of the regulatory review process Final steps before importing your device You'll learn all this and...

If you are thinking about entering the Chinese market for the first time, trying to understand the CFDA regulatory requirements can be overwhelming. Information about medical device regulation on the CFDA website can be confusing and does not tell the full story about how the registration process really works, or what is required of you as a manufacturer. Free information packet makes it easier to understand the process in China To aid medical device manufacturers who want to export to medical devices to China, we have assembled a packet of information for you that includes the basic...

If you are thinking about entering the Australian market for the first time, understanding the Therapeutic Goods Association (TGA) regulatory requirements can be overwhelming. Information about medical device regulations on the TGA website can be confusing and does not tell the full story about how the registration process really works, or what is required of you as a manufacturer. Free information packet makes it easier to understand the process in Australia To help medical device manufacturers who want to export medical devices to Australia, we assembled a packet that includes the basic...

If you are thinking about entering the South Korean market for the first time, understanding Korea's Ministry of Food and Drug Safety (MFDS) regulatory requirements can be overwhelming. Information about medical device regulations on the MFDS website can be confusing and does not tell the full story about how the registration process really works, or what is required of you as a manufacturer. Free information packet makes it easier to understand the process in South Korea To help medical device manufacturers who want to export medical devices to South Korea, we assembled a packet that...

If you are thinking about entering the Singaporean market for the first time, understanding the Health Science Authority (HSA) regulatory requirements can be overwhelming. Information about medical device regulations on the HSA website can be confusing and does not tell the full story about how the registration process really works, or what is required of you as a manufacturer. Free information packet makes it easier to understand the process in Singapore To help medical device manufacturers who want to export medical devices to Singapore, we assembled a packet that includes the basic...

If you are thinking about entering the Mexican market for the first time, understanding COFEPRIS’s regulatory requirements can be overwhelming. Information about medical device regulations on the COFEPRIS website can be confusing and does not tell the full story about how the registration process really works, or what is required of you as a manufacturer. Free information packet makes it easier to understand the process in Mexico To help medical device manufacturers who want to export medical devices to Mexico, we assembled a packet that includes the basic information you need before deciding...

If you are thinking about entering the Canadian market for the first time, understanding Health Canada’s regulatory requirements can be overwhelming. Information about medical device regulations on the Health Canada website can be confusing and does not tell the full story about how the registration process really works, or what is required of you as a manufacturer. Free information packet makes it easier to understand the process in Canada To help medical device manufacturers who want to export medical devices to Canada, we assembled a packet that includes the basic information you need...

If you are thinking about entering the Japanese market for the first time, understanding the PMDA’s regulatory requirements can be overwhelming. Information about medical device regulations on the PMDA website can be confusing and does not tell the full story about how the registration process really works, or what is required of you as a manufacturer. Free information packet makes it easier to understand the process in Japan To help medical device manufacturers who want to export medical devices to Japan, we assembled a packet that includes the basic information you need before deciding to...

If you are thinking about entering the Brazilian market for the first time, understanding ANVISA’s regulatory requirements can be overwhelming. Information about medical device regulations on the ANVISA website can be confusing and does not tell the full story about how the registration process really works, or what is required of you as a manufacturer. Free information packet makes it easier to understand the process in Brazil To help medical device manufacturers who want to export medical devices to Brazil, we assembled a packet that includes the basic information you need before deciding...