INVIMA extends suspension of legal terms and reestablishes a few services

INVIMA issued Resolution No. 2022500005/2022 by which it modifies former resolutions and suspends legal terms until March 17, 2022. The institution reestablished some services in Foodstuff and beverage department, Pharmaceutical department, Cosmetics, cleaning, pesticides and domestic hygiene department, sanitary operations and medical device and IVD department.

Regarding Medical Device and IVD department, following are the processes that can be filed:

i) New applications for medical devices and IVD Class I

ii) New applications for IVD Class II

iii) Authorization for the importation of used biomedicals Class I and IIa and refurbished biomedical equipment Class I, IIa, IIb and III

iv) Free Sales certificate applications for automatic devices.

v) Product exhaustion due to expiry date of medical device registrations.

vi) Application for RUO IVD.

vii) Manufacturer´s medical devices and IVD´s not available registration.

viii) Exhaustion of labels of vital not available products

ix) Recording human resource for the maintenance of biomedical devices Class IIb and III

x) Requires not health registrations.

xi) CCAA visits.

xii) Visits to tissue banks and anatomical components

xiii) Recertification visits.

xiv) Verification of requirements to certification and recertification visits.

xv) Negotiation to mitigate shortage of Medical Devices and IVDs