Device Regulation Changes in Mexico
The Mexican healthcare product regulatory body, Cofepris, has been working to development and release new requirements and agreement for therapeutic goods in Mexico. The changes are described below:
Reduced Review Time for Manufacturers with Existing Japanese Certification:
Cofepris have signed an equivalency agreement which allows for expedited review of certain medical devices which have obtained a market registration certificate from Japan’s regulatory body, PMDA. The agreement, which is expected to come into force on 24 February 2012, applies to Class II, II and IV medical devices. Class I medical devices must still go through the standard Cofepris registration process. The abridged review process allows manufacturers to obtain certification much quicker however they must still supply some technical/certification documentation to Cofepris as evidence. This documentation includes:
- Operating licence(s)
- Notification of exportation
- A Free Sale Certificate (original copy)
- Letter of Representation (original copy)
- Labels and instructions for use which comply with Cofepris requirements
Post market requirements remain unchanged for these manufacturers, along with quality control procedures.
Reprimand for Unapproved Healthcare Products
Legislation is to be introduced in Mexico which is designed to reduce the rapid growth of unregulated products claiming to be miracle cures. A presidential decree amending the General Healthcare Law (the key healthcare law in Mexico) was passed on 18 January 2012 and provides a mechanism for the ban and removal of these product types within a short 24 hour period. The legislation also introduces fines for the product’s suppliers and advertisers.
For guidance on regulatory requirements in international markets, contact KD&A or visit our Regulatory Strategy Page.