K
Hi All
Doing some research for a client of ours, I saw that the new edition of the Mexican Pharmacopea no explicitly lists 'Devices used in in vitro fertilization and assisted reproduction technologies' as medical devices (i.e. it's part of the definition of MDs).
Since I was going through COFEPRIS lists of registered devices and could not find any devices - such as micromanipulators - that are used for IVF/ICSI I was wondering if up to now these devices where simply not considered to be MDs and thus not regulated.
Can anyone share some insights on this?
Doing some research for a client of ours, I saw that the new edition of the Mexican Pharmacopea no explicitly lists 'Devices used in in vitro fertilization and assisted reproduction technologies' as medical devices (i.e. it's part of the definition of MDs).
Since I was going through COFEPRIS lists of registered devices and could not find any devices - such as micromanipulators - that are used for IVF/ICSI I was wondering if up to now these devices where simply not considered to be MDs and thus not regulated.
Can anyone share some insights on this?