Ana Karen Hidalgo Rodríguez, Emergo Group
Continuing with our updates over the recently released 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia (hereafter: Pharmacopoeia), we discuss the classification rules related to medical devices.
Classification of medical devices based on their level of risk
Appendix II of the Mexican Pharmacopoeia includes the criteria under which medical devices are classified in Mexico based on their risk level.
The established criteria have always been presented as rules, indicating the characteristics of medical devices in relation to their use, activity, contact and permanence with the body. The rules-based system is based on the former Global Harmonization Task Force (GHTF), now the International Medical Device Regulators Forum or IMDRF, and EU Medical Devices Directive MDD 93/42/EEC. In addition, the revised rules appear to consider the EU Medical Devices Regulation 2017/745 (MDR). Understanding and following these rules will help with obtaining a registration for medical devices in Mexico.
There are an additional 12 rules added to the 23 previous rules, 10 of which are related to IVDs, and which will be discussed in another Regulatory Update.
There are now seven classification categories. In this newly published version of the Pharmacopoeia, medical device categories have increased from six to seven, with the seventh exclusive for software as a medical device (SaMD) and its corresponding definition (discussed in our previous update):
- Medical Equipment
- Orthesis and functional aids, IVDs
- Dental Supplies
- Surgical and healing materials
- Hygiene products
The categories may seem immaterial to manufacturers, but are used by COFEPRIS regulators in their organization and review.
Get the full story — including rules for invasive and noninvasive medical devices — at the Emergo Group’s blog.
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