Mexican Regulators Overhaul Medical Device, IVD Classification Rules
EMERGO SUMMARY OF KEY POINTS:
- Mexican regulators have updated classification and related requirements for medical device and IVD registrants.
- COFEPRIS has up-classified most IVD products and clarified definitions pertaining to medical device regulations.
- COFEPRIS first announced these planned changes in early 2017.
Mexico’s medical device and IVD market regulator COFEPRIS has made significant updates to its classification process for devices marketed in the country.
According to Emergo consultants in Mexico City, recent revisions to the Mexico Pharmacopea (link in Spanish) include changes to device classification rules and related definitions first discussed by COFEPRIS and reported on by Emergo in early 2017.
Key COFEPRIS classification changes
Appendix II of the latest version of Mexico Pharmacopea features updated as well as new definitions to clarify which types of devices fall under which categories.
One of the most significant new Mexican classification changes pertains to IVD classification. COFEPRIS, now has a set of rules rather than just one for IVD products; most IVDs are now considered Class II, except:
- Reagents, calibrators and control solutions used for specific tests (now Class I IVDs)
- Contrast media and/or radioactive substances used to diagnose, treat or monitor physiological processes and that can be used as auxiliaries to other procedures administered intravenously (now Class III IVDs)
Appendix II also defines IVDs as devices used on their own or together with other products to provide information for detection, diagnosis and/or monitoring of conditions or diseases.
Other significant changes included under Appendix II of the new Pharmacopea include:
- “Medical Equipment” has been defined as a product requiring calibration, maintenance, repair and training for operation, as well as dismantling. Medical equipment’s purpose is to monitor, diagnose or treat a disease or rehabilitation, and the category no longer includes implantable devices or disposable or single-use devices.
- The “Surgical and Healing Supplies” category now includes substances used together with medical devices for disinfection, decontamination or sanitization purposes.
- The previously nebulous term “a potentially dangerous way” has been clarified, pertaining to the type of technology involved and intended use of the device in question more so than its design; manufacturers should ensure that their designs adequately address risks.
- Class I low-risk devices are now described as having no diagnostic or life support functions, and whose use does not present any risk of physical harm to patients or users.
New definitions and data requirements
Appendix III of the new Pharmacopea expands upon COFEPRIS’s existing definition of “medical device” to include intended uses such as life support, animal and human tissues, in-vitro fertilization and assisted reproduction. Although stand-alone medical software remains unregulated under the new rules, software that goes along with any medical equipment must be registered along with that equipment.
High-risk device manufacturers should also take note that COFEPRIS applications for Class III implantable devices must include preclinical and biocompatibility study data; Class II implantable device applications as well as applications for Class II non-implantable products must include in vitro and in vivo biological reactivity test data, according to Appendix III.
Appendix III also states that COFEPRIS now requires Mexican market registrants to provide technovigilance reports; submission of these reports had previously been optional. However, it is not yet clear whether COFEPRIS will require technovigilance reports for device registrations currently under review, or only for new applications coming in after the new regulatory rules’ publication.