Colombia Blog Posts

Colombian Regulators Speed Up Medical Device, IVD Review Timeframes

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.
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Colombia Allows Faster Renewals for Lower-risk Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Colombian regulator INVIMA is speeding up registration renewals for Class I and IIa medical devices.
  • Registrants must still submit applications for renewal to INVIMA, but now will be granted those renewals within three days.
  • The new INVIMA policy went into effect October 3, 2016.
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Colombian Regulators Now Consider Medical Displays Medical Devices

INVIMA, the Colombian medical device market regulator, has announced that medical displays are now considered Class IIa medical devices subject to registration requirements in the country.

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The medical devices market in Latin America

Most people don’t realize it, but taken together, the major Latin American countries—Brazil, Mexico, Colombia, Chile, and Argentina—represent the third largest economy in the world, with a healthcare expenditure comparable to China and India. Their combined GDP exceeds $4.25 trillion and the medical device industry has grown into a significant combined market. It’s no surprise that medical device companies have their eye on Latin America.

Starting points: Mexico & Brazil

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