About INVIMA

INVIMA (National Institute for Food and Drug Surveillance) is Colombia’s regulatory agency. It was create by the Colombian Ministry of Health to supervise and supervise the production and commercialization of health products in the country. The agency is a leader in the region and has the level four of the World Health Organization (WHO). INVIMA regulates the medical device market in Colombia. To market your medical device in Colombia, you must obtain a sanitary registration (also known as a marketing authorization or sanitary registry) from INVIMA.

INVIMA requires that your medical device be approved in a founding member country of GHTF (i.e. Australia, Canada, European Union, Japan and the United States of America) or in a country that has an existing mutual recognition regulatory agreement with Colombia. Foreign manufacturers have the option of having the INVIMA registration certificate issued in the name of their company and maintaining control over their registrations in the Colombian medical device market, as long as they have a duly established company headquarters in Colombia. before the Chamber of Commerce and comply with Resolution 4002 of 2007; have CCAA capacity and storage certification issued by INVIMA, in case of not having a local office, Elysian Fields Colombia is able to find the best medical device distribution company that meets all the requirements and certifications required by INVIMA for import and sales medical devices and equipment. Preserving the ownership of the registration for the manufacturing company if so desired.

Accordingly, the Elysian Fields Regulatory Business Unit in Colombia provides the following services.

Invima health registration, our service includes:

• Creation of the Dossier (Request + required documents)
• Application filing
• Response to INVIMA requirements
• Respond to subsequent requirements that INVIMA may request

CCAA capacity and storage certification, Our service includes

• Quality system documents
• Verification of storage areas
• Training for the technical direction of the company
• Training and advice to the storage area during the documentation process.

Sanitary conditions certification – Manufacturers, our service includes

• Quality system documents
• Verification of manufacturing and storage areas
• Training for technical management
• Training and advice to the areas of processes, manufacturing and storage, during the document development.