EMERGO SUMMARY OF KEY POINTS:

• Colombia’s INVIMA is attempting to reduce review timeframes for medical device and IVD registrations.
• Modification applications for devices and IVDs will be granted automatically by INVIMA, but still go through full review.

Medical device and in vitro diagnostic (IVD) market regulators in Colombia have pushed through changes to registration and modification processes with immediate effect.

INVIMA, Colombia’s medical device and IVD regulatory agency, issued Decree No. 582/17 pertaining to medical devices and Decree No. 581/17 for IVDs (links in Spanish) in early April 2017. Some of the changes included in these decrees are substantial, such as automatic renewals of some product registrations.

Changes to INVIMA’s medical device review process

According to Emergo sources in Bogota, key changes to Colombian medical device regulations under Decree 582/17 include review timeframes and automatic modification acceptance by INVIMA.

First, for Class IIb and III moderate- to high-risk devices, INVIMA will review registration applications within 90 working days following submission. Although official review timelines are already 90 working days, actual timelines can last as long as six months; Decree 582/17 now obligates INVIMA to conduct more efficient application reviews within 90-day timeframes.

Faster device modification application reviews, too

Regarding changes to device registrations, applications for modifications to existing registrations will be automatically granted by INVIMA within two working days after submission. This allowance will allow Colombia medical device registrants to avoid disruptions to supplying their products on the market while modifications are being evaluated.

INVIMA must still approve modification applications, however, even after automatically granting them upon receipt from Colombia market registrants. The regulator will approve such modifications provided that applicants can demonstrate that changes do not affect their devices’ safety and effectiveness.

Approval of such applications entails submission review and requests for additional information from registrants; applicants will have 90 working days to respond to INVIMA requests for additional information.

Previously, INVIMA’s official timeframes to review modification applications was 30 working days, but such reviews could sometimes take up to three months.

Allowances for lapsed registrations

Finally, Decree No. 582/17 establishes a process whereby Colombia market registrants can submit applications for exhaustion for devices whose INVIMA registrations have lapsed and will not be renewed. This means that once a device’s registration expires, a company may continue selling batches of that product that they’ve already imported into Colombia but not yet sold, provided that the firm applies for an exhaustion of product certificate from INVIMA.

Changes to how INVIMA regulates IVDs

Colombian regulators have implemented similar changes to IVD regulation under Decree No. 581/17.

First, INVIMA has made it mandatory to obtain approval from specialized review boards in Colombia for Class III IVD registrations, unless a device meets the following requirements:

• The IVD is already commercialized in a country of reference (the United States, Europe, Canada, Japan and/or Australia)
• The IVD’s Certificate of Free Sale (CFS) shows the specific names of the product’s reagent and models
• The IVD’s CFS was issued within one year prior to submission of the registration application to INVIMA

Registration renewals for Class I and II low- to moderate-risk IVDs will now be automatic, according to INVIMA. The regulator may still request additional information on a product at any time, however, and will allow registrants 30 working days to reply to such requests.

New modification review policies for IVDs resemble those mentioned previously for medical devices. Modification applications will be automatically granted by INVIMA, and resolutions will be granted within two business days following application submissions.

Also as with the case of medical devices, modification applications will still be reviewed to determine impacts on IVDs’ safety and effectiveness; if INVIMA requests additional information regarding an IVD modification application, a registrant will have 30 working days to respond.

Overall, these new decrees should ease Colombian market access for medical device and IVD registrants, as well as reduce regulatory burdens for companies making changes to devices already commercialized in the country.

Colombian market services and resources:

• Colombia registration support for medical device companies
• Certificate of Free Sale (CFS) procurement service for companies importing to Colombia
• INVIMA medical device regulatory process chart