MHRA vs COFEPRIS: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of MHRA (United Kingdom) vs COFEPRIS (Mexico).
MHRA
Medicines and Healthcare products Regulatory Agency
United Kingdom
Post-Brexit, the MHRA operates an independent regulatory framework for medical devices in the UK. The UK Conformity Assessed (UKCA) marking is replacing CE marking for the UK market. The MHRA is devel…
Class I, IIa, IIb, III
UKCA marking via UK Approved Body
- ▸UKCA marking
- ▸UK device registration
- ▸Yellow Card adverse event reporting
- ▸UK Approved Body oversight
COFEPRIS
Federal Commission for Protection against Health Risks (Mexico)
Mexico
COFEPRIS regulates medical devices in Mexico under the General Health Law. Mexico uses a three-class system (I, II, III). A sanitary registration (registro sanitario) is required for Class II and III …
Class I, II, III
COFEPRIS sanitary registration
- ▸Sanitary registration
- ▸FDA/EU recognition pathway
- ▸GMP compliance
- ▸Import permits
- ▸Vigilance reporting
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