In recent months, due to the global pandemic, there have been several changes in medical devices market and its regulation in Mexico. In this article, we describe the most relevant changes that any regulatory affairs professional in the industry shall consider.
You can also check our first update in this link.
Submissions to COFEPRIS and return of responses
The first regulatory change to mention is regarding the request and response process of priority requests at COFEPRIS. To avoid agglomerations in the main offices of COFEPRIS located in Mexico City (CIS), the commission implemented measures to keep receiving requests by using courier services such as FedEx, DHL, UPS among others. In general terms, any company requesting a procedure with COFEPRIS must send a prepaid shipping guide.
COFEPRIS Confirmed submission list
The process of reception and return of requests as previously described, caused a lack of traceability by users. All companies needed to wait for weeks for a response with the entry number assigned to each request only to confirm that request had been received correctly by COFEPRIS and finally be able to follow-up the response in COFEPRIS website. To solve this issue, COFEPRIS published a list of entry numbers updated periodically. In the above-mentioned list, the users can quickly find their tracking numbers assigned by courier and those numbers are related with its corresponding entry number for each request to follow up the response in the COFEPRIS website.
List of serological tests for detection of SARS CoV-2.
With the aim of protecting the health of the population from rapid tests for SARS CoV-2 clandestinely sold without a sanitary registration, COFEPRIS published a list of all rapid tests that have been authorized for its marketing. COFEPRIS updates this list once a new test has completed the temporary authorization process for this type of medical device.
Government direct purchases
In the last days with focus on guarantee the supply of health products, including medical devices. Legislators have promoted an amendment to a Law that would allow the Mexican Government making direct purchases abroad without requiring authorizations or tenders. If the amendment to this law is approved, the sector would be negatively affected since a large part of the income of several distributors of medical devices comes from sales to the Government.
Companies and professionals in the sector must monitor the changes mentioned above and those that may arise in the coming months.