Panama medical device registration process

Panama medical device registration process

Panama medical device registration process

MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Panama.

Device classification in Panama

The medical device classification in Panama is based on the GHTF/IMDRF rules. Determining the classification for your medical device might be challenging and is critical to ensure a smooth registration process. We have many years' experience with Panama medical device classification.

Finding Authorized Representative in Panama

Companies without presence in Panama must appoint an in-country Authorized Representative. We will help you find a reliable Authorized Representative in Panama.

Registration documentation

The applicant must submit the regulatory documentation to register their product. All the documents must be kept up to date and available for inspections for the entire period of registration validity. MDRC will prepare your documentation in accordance with DNDM / MINSA regulatory requirements. We will also advise you on device labeling requirements and IFU in accordance with regulations of Panama.

Panama quality system requirements

If you do not have QMS certificates acknowledged by authorities of Panama, we will advise you on what modifications must be made to your existing quality system to achieve regulatory compliance in Panama.

Medical distributor qualification in Panama

While your registration is being finalized, our distribution specialists can help you find and evaluate distributors in Panama. This will increase the chances of finding a partner who is qualified and able to effectively market your products.

Additional information

Validity 10 years
Language Documents and Labeling must be in Spanish
Postmarket Surveillance N/A
Expected Time Official review time is 60 work days. If DNDM requests additional information the timeline will be extended over another 60 days.
Panama medical device registration process

MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Panama.

Device classification in Panama

The medical device classification in Panama is based on the GHTF/IMDRF rules. Determining the classification for your medical device might be challenging and is critical to ensure a smooth registration process. We have many years' experience with Panama medical device classification.

Finding Authorized Representative in Panama

Companies without presence in Panama must appoint an in-country Authorized Representative. We will help you find a reliable Authorized Representative in Panama.

Registration documentation

The applicant must submit the regulatory documentation to register their product. All the documents must be kept up to date and available for inspections for the entire period of registration validity. MDRC will prepare your documentation in accordance with DNDM / MINSA regulatory requirements. We will also advise you on device labeling requirements and IFU in accordance with regulations of Panama.

Panama quality system requirements

If you do not have QMS certificates acknowledged by authorities of Panama, we will advise you on what modifications must be made to your existing quality system to achieve regulatory compliance in Panama.

Medical distributor qualification in Panama

While your registration is being finalized, our distribution specialists can help you find and evaluate distributors in Panama. This will increase the chances of finding a partner who is qualified and able to effectively market your products.

Interested in Panama market?

Contact us!