Latest Medical Device Registration Fee Schedule Published by Argentinean Regulators

Argentina’s medical device market regulator ANMAT has published its latest schedule (link in Spanish) of annual maintenance fees for both new and renewed registrations.

For existing medical device registrations, ANMAT has set the following fees:

• Class I: AR$ 600 (about $70 USD)
• Class II: AR$ 800 (about $100 USD)
• Class III: AR$ 1100 (about $130 USD)
• Class IV: AR$ 1500 (about $180 USD)

For new registrations, slightly higher fees have gone into effect:

• Class I: AR$ 700 (about $85 USD)
• Class II: AR$ 1000 (about $120 USD)
• Class III: AR$ 1300 (about $155 USD)
• Class IV: AR$ 1900 (about $230 USD)

Delayed requirements for medical device distributors

In addition, ANMAT has delayed implementation (link in Spanish) of new requirements for device distributors until early 2015. The Good Storage Practice requirements follow ANMAT Provision 6052-2013, which established regulatory requirements for distributors for the first time in 2013 in Argentina.