MEDICAL DEVICE MARKET ACCESS CONSULTING

ENFISA S.A.S. has the resources and experience to serve as your legal representative in Colombia and help you bring your medical or pharmaceutical device to the Colombian market. Our company can offer the hosting service for generics, new molecules and medical products of Class I, II and III in Colombia. With more than 75 years of combine experience in the market, ENFISA S.A.S. can help with modifications, processing of import license, renewals and extensions of sanitary records and more. It must maintain its established relations with INVIMA and DIAN while marketing its products in Colombia. ENFISA S.A.S. has the power to help its clients with the management of these important relations in the country.

Because we work in so many different markets, we fully understand complex national regulations and where they overlap. We apply this knowledge for your benefit in a way that could not be achieved by working with separate consultancies or affiliates with limited local expertise. We will develop customized regulatory strategies that leverage your existing registrations. Whether you have one product or hundreds, we can help you expand your market in Colombia

Enfisa’s quality management consultants bring lots of experience with medical device QMS development, implementation, and audits for all device risk levels. We can help you establish and maintain a quality management system that meets QMS requirements wherever your product is sold.
We also assist with gap analyses, due diligence, and internal, supplier, and preassessment audits. Our consultants guide you through every step of the process, including writing quality management system procedures, conducting and monitoring the implementation, and training your employees. We also assist in on-going compliance and maintenance of your QMS following implementation and certification (where applicable).

• How are medical devices classified in Colombia?
• What is the medical device registration process in Colombia?
• How long does it take to obtain INVIMA approval for medical devices?
Marketing your medical device in Colombia requires registration with the National Food and Drug Surveillance Institute (INVIMA), the country’s medical device regulator.
The first step towards INVIMA regulatory approval is to determine the correct classification of your medical device. Device classification in Colombia follows a four-tiered risk model (Class I, Class IIa, Class IIb and Class III) that is similar to the classification scheme used in Europe.
STEPS TO DEVICE REGISTRATION IN COLOMBIA
Once you determine the correct classification of your medical device, you must complete the following steps to bring your device to market in Colombia.
1. Appoint an in-country representative, such as a Legal Representative, if you have no local presence in Colombia.
2. Obtain a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) from your home country or an INVIMA recognized market.
3. Provide a quality system certificate, such as ISO 13485.
4. Provide product information and the commercial history of the product; test reports will be required for Class IIa, IIb and III devices, and clinical data will be required for Class IIb and Class III devices.
5. Submit these materials to INVIMA in Spanish and pay required application fee.
6. Once approved, INVIMA will issue a registration certificate.

INVIMA allows immediate acceptance of Class I and IIa device submissions. The full technical file must still be submitted for review by INVIMA, but certificate issuance is immediate and manufacturers can begin importing right away. Once the formal review begins, the manufacturer must respond to INVIMA’s requests in order to maintain the registration. This allowance was implemented to help address the long review times and large backlog experienced within the Ministry of Health.
Class IIb and III devices are not eligible for this process and must wait until formal review and approval are complete, generally within six months, to begin selling.

Enfisa has extensive experience helping medical device manufacturers register their products in various South American markets. Here’s how we can help:
• If selected as your Legal Representative, we will prepare registration materials for submission, communicate with INVIMA on your behalf, and assist with incident reporting, if requested.
• Our consultants stay up to date on the latest Colombian regulatory and quality assurance issues to ensure that you experience a smooth and efficient registration.
• We can assist you in selecting Colombian distributors based on your sales and marketing requirements.
• We can assist with registering your trademark in Colombia to protect the trademark from infringement by third parties.
From our offices in Medellin, we can fully support your Colombian market registration effort.

Is home country approval required?
Before beginning your Colombia medical device registration process, you must secure home country approval. If you don’t have approval in your home market, you can provide a CFS/CFG from one of the following markets: Australia, Canada, Japan, Europe, or the United States.
When am I required to renew my registration in Colombia?
Registrations are valid for 10 years. Application renewals are due to INVIMA three (3) months before the expiration of your registration certificate.
What if we do not have ISO 13485 certification?
The regulation states proof of a QMS (such as ISO 13485) is required. However, you can meet this requirement another way (e.g., providing an ISO 9001 certificate or an FDA Establishment Report).