Priscila CenraThis inquiry has been consulted. > qa

NAME	Priscila Cenra
EMAIL	geral@priscilacenra.com
TELEPHONE	+351 914761444

Hello,

I have an Aesthetic Medicine clinic in Portugal and would like to know how I can become a distributor of your products in Portugal.

I already use the Elasty filler, which I buy from a vendor in Korea. However, I would like to register your products with Portugal's regulatory agency, Infarmed, so that I can obtain authorization for import and sale in Portugal.

Infarmed requests the following documents:

1. Declaration of Conformity (or EU Declaration of Conformity): This document is issued by the manufacturer and certifies that the product complies with the requirements established in European legislation for medical devices.

2. Certificate of Conformity (if applicable): If the product has been assessed by a Notified Body for certification, the Certificate of Conformity issued by that body is required.

3. Technical documentation: Detailed information about the product, including the PDF of the packaging and the instructions inside the packaging.

Could I obtain the instructions in Portuguese?

On the website I will send below, you can check the products and manufacturers that have already been registered with Infarmed, which may help you understand better what is required.

Thank you for your attention, and I look forward to your response.

Best regards,

Priscila Cenra
Manager
Cenra Institute Unip. Lda.