On November 29th, 2019, the National Administration of Medicines, Food and Medical Technology of Argentina announced provision 9688/2019, which aims to accelerate the obtaining, validation, and modification of national and imported Class I, II, III, and IV registrations for medical products.

The adjustment aligns with Decree 891/17 and is considered essential for developing a systemic and comprehensive strategy. The primary goal is regulatory improvement as an ongoing task of the public sector, open to societal participation. This includes reducing excessive procedures, simplifying processes, and preparing norms that contribute to an efficient and predictable state responsive to citizens' needs.

Applicable Requests

This provision applies to the following requests:

1. Registration in the Registry of Producers and Medical Technology Products of Class I, II, III, and IV medical products, both national and imported.
2. Modifications to the registry of national and imported Class I, II, III, and IV medical products.
3. Valid registration of Class I, II, III, and IV medical products, national and imported.
4. Transfer of registration of Class I, II, III, and IV medical products, national and imported.
5. Cancellation of registration of Class I, II, III, and IV medical products described.

This provision also applies to groups of products without intended medical purposes, whose use in human health is similar to that of a medical product, either directly or indirectly (Annex 1).

Registration Mechanism

The registration for Class III and IV medical products will feature an expedited registration mechanism, requiring the following data:

• Technical name and/or descriptive name
• Presentation forms
• Brand
• Processing plant of the imported product
• Change of sterilization method
• Modification of the information contained in the labels and/or instructions for use (without modifying any other characteristic data)
• Useful life

The Declaration of Conformity signed by the National Institute of Medical Products (INPM) will serve as the record of registration in the RPPTM.

This provision will come into force 60 (SIXTY) business days following its publication in the Official Gazette.

For more information, please contact info@orbiscompliance.com - mailto:info@orbiscompliance.com or (408) 465-7331.

Based on the Official Gazette of the Argentine Republic website.