On 16 November 2021 a new Coordination Agreement (CA) over Health Control, executed between the Federal Ministry of Health and the State of Baja California (“Baja“), was published on the Federation’s Official Gazette. This new CA has a special impact on Baja’s medical devices industry. It greatly improves the regulatory environment.
To be able to see additional first steps, companies should review their Response Plans for Potential Inspections. This includes revising inspection orders to ensure that federal authorities initiated the inspections.
It is important to note that many administrative procedures, previously handled locally, will now be handled federally. This includes, for example, the filing of Notices of Operation.
This, combined with the recent launch of an online platform for electronic submission of Notices of Operation to the federal level, is a significant improvement in the local regulatory environment, especially given the number of local abuses that have been affecting this sector recently.
- These CAs can be used by the Federation for the distribution of the powers of Health Regulation and Control among the States authorities.
- There are three possible scenarios for exercising health powers in these CAs: (i) procedures handled solely by the Federal authority, or (ii) jointly handled procedures at both levels. (iii). Procedures handled entirely by the State authorities.
- Previously, administrative procedures could have been handled jointly. However, the new CA makes it clear that key procedures for medical devices such as Notices of Operation for Manufacturing and Warehousing fall under the exclusive jurisdiction of the Federation.
- When choosing from one of the CAs, you can also define the inspection powers of local authorities. In the case of medical devices, the federal authorities have instructed local authorities to stop conducting inspection visits.
Baker McKenzies Healthcare & Life Sciences team can provide further information and discuss the regulatory and larger implications of this important change.