INVIMA Updates Sanitary Requirements for Developing External Orthopedic Devices
Colombia’s Instituta Nacional de Vigilancia de Medicamentos y Alimentos has updated regulations governing the sanitary requirements related to laboratories developing external orthopedic prosthetics and orthotics.
In a Sept. 14 notice posted to INVIMA’s website in November, the regulator informs labs that they must comply with a resolution issued in August that covers good manufacturing practices for these types of devices.
Establishments manufacturing external orthopedic technology and orthotics must register with INVIMA during the last quarter of the year. Facilities must include information, such as the owner’s name and the address of the establishment, legal representation, department codes and the municipality, telephone number and email address.
The resolution also informs that it is incumbent upon the facility to request an authorization inspection from an INVIMA representative, after which it may open and conduct operations.
In the first quarter of 2016, INVIMA will establish a procedure to request an authorization to operate. It will identify the documents to request verification visits and the duration of inspections, among other activities.
Because INVIMA has yet to establish new rates for these inspections, companies are asked to refrain from requesting them until the prices are updated.
The resolution updates a 2010 decree that defined the technical and health requirements that manufacturers must meet. Previously, no such regulations existed. As part of Resolution 1319, providers had to be on an INVIMA list to provide prosthetics and orthotics to patients. However, the government decided to give providers more time to comply.
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