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 particular impact over the medical devices industry operating in Baja, improving greatly the regulatory environment.
What it means for you?
Companies need to review their Response Plans for Potential Inspections, to foresee additional first steps, such as revising inspection orders to make sure that federal authorities originated the inspections.
In addition, it must be noted that many administrative procedures previously handled locally would now be handled federally, including for example, filing of Notices of Operation.
Combined with the recent launch of a new online platform for electronic submission of Notices of Operation at the federal level, this is an important improvement of the local regulatory environment, especially considering that local abuses had been affecting the sector lately.
In more detail
Noteworthy, the CAs are crucial because:
- These CAs are used by the Federation to distribute the powers of Health Regulation and Control with the States authorities.
- In these CAs, there are three scenarios for exercising health powers: (i) procedures handled exclusively by the Federal authority, (ii) procedures handled jointly at both levels, and (iii) procedures handled in full by the State authorities.
- Previously, many administrative procedures could be dealt jointly. However, under the new CA, key procedures for medical devices, such as Notices of Operation for Manufacturing and Warehousing, now fall under the exclusive power of the Federation.
- Furthermore, the inspecting powers of local authorities are also defined when choosing one of the aforementioned scenarios in the CAs. Thus in the case of medical devices, local authorities can no longer conduct inspection visits, unless instructed by the federal authorities.
For further information and to discuss the regulatory and wider implications of this important amendment, please get in touch with Baker McKenzie’s Healthcare & Life Sciences team.