MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Paraguay.
The medical device classification in Paraguay is based on rules. Determining the classification for your medical device might be challenging and is critical to ensure a smooth registration process. We will help you determine the classification of your products.
Companies without presence in Paraguay must appoint an in-country Legal Representative. We will help you find a reliable Legal Representative in Paraguay.
The applicant must submit the regulatory documentation to DINAVISA to register their product. MDRC will prepare your documentation in accordance with the DINAVISA regulatory requirements. We will also advise you on device labeling requirements and IFU in accordance with regulations of Paraguay.
If you do not have QMS certificates acknowledged by the authorities of Paraguay, we will advise you on what modifications must be made to your existing quality system to achieve regulatory compliance in Paraguay.
Our distribution specialists can help you find and evaluate distributors in Paraguay. This will increase the chances of finding a partner who is qualified and able to effectively market your products.
| Validity | 5 years |
| Language | Documents and Labeling must be in Spanish |
| Postmarket Surveillance | N/A |
| Expected Time | No official review timeline |
MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Paraguay.
The medical device classification in Paraguay is based on rules. Determining the classification for your medical device might be challenging and is critical to ensure a smooth registration process. We will help you determine the classification of your products.
Companies without presence in Paraguay must appoint an in-country Legal Representative. We will help you find a reliable Legal Representative in Paraguay.
The applicant must submit the regulatory documentation to DINAVISA to register their product. MDRC will prepare your documentation in accordance with the DINAVISA regulatory requirements. We will also advise you on device labeling requirements and IFU in accordance with regulations of Paraguay.
If you do not have QMS certificates acknowledged by the authorities of Paraguay, we will advise you on what modifications must be made to your existing quality system to achieve regulatory compliance in Paraguay.
Our distribution specialists can help you find and evaluate distributors in Paraguay. This will increase the chances of finding a partner who is qualified and able to effectively market your products.
