Importation of medical devices for fixing or repairing receives new guidelines from Anvisa.May 16, 2023
Anvisa released information to the regulated sector that the subject code 90370, which deals with the consent to import used medical products to fix or repair by a legal entity, was deactivated.
After this measure, importation for this purpose must take place through the subject codes for commercial and industrial purposes, since only the national manufacturer, which holds the regularization, is allowed to import in these cases.
Check below some excerpts from the rule that regulates the subject and find out how to file these processes:
The RDC 81/2008 details some situations of import consent for fixing purposes:
1) Chapter XXXIV deals with the consent for the return of goods or products exported to provide services or fix or repairs outside the country.
- a) This consent refers to a previously nationalized medical device that has been exported to provide service or fix, repair, or restoration outside the country.
- b) The subject code that must be used is “90358 – Import consent for return of goods after fixing, repairs or restoration, submitted for temporary export”.
- This subject of the petition also includes the return of medical devices temporarily exported for exhibition at events and fairs.
- c) For the correct procedural instruction of the import process, the documents are necessary:
- Purchase invoice or declaration of ownership of the good or product, in which its technical specifications are described, such as trade name, brand, model, and manufacturer, signed by the person in charge, natural or legal person, in the latter case, by its legal representative; and
- Export declaration or equivalent customs document proving the exit of the good or product.
2) Chapter XXXII, on the other hand, covers the consent to import goods or exported products, produced in the national territory and returned.
- a) This approval involves, for medical devices, products manufactured in the country that were exported, but had to return to the country of origin for different reasons, such as rejection (destruction or return of the product) or fixing, for example.
- b) The subject code that must be used in this case of rejection is “90449 – Import approval for the return of a health product produced in the national territory and rejected abroad”.
- c) If the return is for product fixing, the subject code must be for industrial purposes, as the product will be obligatorily imported by the domestic manufacturer, in a used condition, for fixing, including reconditioning, as the case may be.
- d) The procedural instruction documents for subject 90449 are:
- The importer will have to submit to the health authority the information regarding the return and destination of the good or product, in addition to the Analytical Report of Quality Control carried out abroad; It is
- Procedural Instruction Documents of Procedure 4 or 5.5. (depending on the class of the medical device), of Chapter XXXIX of the Annex to RDC 81/2008.
- e) For the return of a used medical device to fix by the national manufacturer, the procedural instruction will be indicated in procedure 4 or 5.5. (depending on the class of medical device) of Chapter XXXIX of the Annex to RDC 81/2008.