MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Chile.
The medical device classification in Chile is based on 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 Chile medical device classification.
Companies without presence in Chile must appoint an in-country Legal Representative. The conformity assessment is carried out by so called Authorized Bodies. We will help you find a reliable Legal Representative and an Authorized Body in Chile.
The applicant must submit the regulatory documentation to an Authorized Body and later to ISP to register their product. MDRC will prepare your documentation in accordance with ISP regulatory requirements. We will also advise you on device labeling requirements and IFU in accordance with regulations of Chile.
If you do not have QMS certificates acknowledged by the authorities of Chile, we will advise you on what modifications must be made to your existing quality system to achieve regulatory compliance in Chile.
While your registration is being finalized, our distribution specialists can help you find and evaluate distributors in Chile. This will increase the chances of finding a partner who is qualified and able to effectively market your products.
| Validity | Does not expire |
| Language | Documents and Labeling must be in Spanish |
| Postmarket Surveillance | N/A |
| Expected Time | Official review time is 60 work days. |
MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Chile.
The medical device classification in Chile is based on 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 Chile medical device classification.
Companies without presence in Chile must appoint an in-country Legal Representative. The conformity assessment is carried out by so called Authorized Bodies. We will help you find a reliable Legal Representative and an Authorized Body in Chile.
The applicant must submit the regulatory documentation to an Authorized Body and later to ISP to register their product. MDRC will prepare your documentation in accordance with ISP regulatory requirements. We will also advise you on device labeling requirements and IFU in accordance with regulations of Chile.
If you do not have QMS certificates acknowledged by the authorities of Chile, we will advise you on what modifications must be made to your existing quality system to achieve regulatory compliance in Chile.
While your registration is being finalized, our distribution specialists can help you find and evaluate distributors in Chile. This will increase the chances of finding a partner who is qualified and able to effectively market your products.
