A comparative study of medical device regulation between countries based on their economies

Figures & data

Table 1. Comparison of medical device regulations in the US & EU, India and Africa.

	US	EU	India	Africa
Regulatory Body	FDA,	European Commission	CDSCO	Various regulatory authorities in each country
Classification	In the US medical devices are classified into three risk classes: I, II and III [61].	For EU- Medical devices are classified according to four risk classes (I, IIa, IIb and III) [61].	GHTF framework (4 categories) Class A-D	Varies with national regulations
Pre-market Approval Methods	510(k), PMA	CE Mark, Conformity Assessment	Registration, MDR Compliance	Varies by nation, limited harmonization
Use of AI in Medical Devices	FDA Action Plan on AI	Regulation and Guidelines, forthcoming AI legislation	Evolving regulations; AI inclusion in MDR	Limited; challenges in some regions
Post-market surveillance	Mandated by FDA	Mandated by MDR	Mandatory for medical device approval	Varied; some countries may have limited oversight
FutureDevelopments	Continual updates and adjustments	Introduction of EUDAMED, AI regulations (forthcoming)	Ongoing updates; Emphasis on harmonization	Initiatives for trustworthy frameworks and benchmarks

This table offers a comparison of the laws governing medical devices in the US, the EU, India, and several African nations.

Figure 1. Comparative Analysis of regulative legislation between US, EU, Africa and India.

Mayer CC, Francesconi M, Grandi C, et al. Regulatory requirements for medical devices and vascular ageing: an overview. Heart Lung Circ. 2021;30:1658–1666. doi: 10.1016/j.hlc.2021.06.517 Cited: in: PMID: 34362673.

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