The National Institute for Food and Drug Surveillance (Invima), reported on September 1, 2022 that it issued Circular No. 5000-0001-22, through which guidelines on the application of Decree 4725 of 2005 are clarified and updated.
To obtain a health registration for a new medical device, or a renewal of the registration or a modification, both technical and legal requirements must be met; Invima's intention with this circular is to unify the criteria and provide greater clarity to the guidelines.
Some of the guidelines, on which this circular makes clear are:
Procedure for the authorization of the parts, components, accessories or spare parts of biomedical equipment
Apostille and legalization of free sale certificates (CVL)
Some aspects related to the inclusion of references
Required technical documents
There is a risk of an adverse event occurring when parts, components, accessories or spare parts are used that have not been designed and approved by the manufacturer of the biomedical equipment. For this reason, they must be covered by a Sanitary Registry or Marketing Permit.
There are 3 situations in which the parts, components, accessories or spare parts are included in the Sanitary Registry and/or Marketing Permit of a biomedical equipment:
Situation | Comment |
When the inclusion of parts or spare parts is not explicitly filled out in the request | En este caso en el acto administrativo que se expida llevará la observación: "ESTE REGISTRO SANITARIO y/o PERMISO DE COMERCIALIZACIÓN AMPARA LOS ACCESORIOS Y REPUESTOS EXCLUSIVOS DEL EQUIPO" |
When the parts or subsystems of the equipment are completed in the application | Only those parts or subsystems will be included. |
When a list is attached in which the accessories, consumables and exclusive spare parts of the equipment are listed | These will appear in detail within the approval resolution of the Registry, regardless of whether they are manufactured by a third party for the manufacturer of the biomedical equipment. |
It is not necessary that all the parts, accessories or spare parts be explicitly described in the Sanitary Registry and/or Marketing Permit of a biomedical equipment.
The registration holder must report in the application the legal or responsible manufacturers of the equipment that appear on the labels.