Regulations

Issued under the Drugs and Cosmetics Act 1940, the Medical Devices Rules 2017 brought all device classes under CDSCO regulation in phases. Class A/B since October 2021; Class C/D since October 2022.

The South Korean Medical Devices Act (MFDS) governing approval, manufacturing, import, and post-market surveillance of medical devices. Last major amendment 2020.

The Japanese law governing quality, efficacy and safety of pharmaceuticals and medical devices. Regulated by MHLW and PMDA. Major revisions in 2014, 2019, and 2022.

State Council Order No. 739 (2021), the top-tier Chinese regulation for medical devices. Effective June 1, 2021, replacing Order No. 650. Enforced by the National Medical Products Administration (NMPA).

ANVISA RDC 751/2022, effective March 2023, governs medical device registration in Brazil with a risk classification aligned to EU MDR classes I–III. Replaced RDC 185/2001.

The core UK medical device legislation as amended post-Brexit. Governs placing devices on the Great Britain market under MHRA oversight. New UK MDR framework under development.

Covers all labeling requirements for medical devices including labels affixed to the device and all descriptive and informational literature that accompanies it.

Mandatory reporting for incidents where a device may have caused or contributed to death or serious injury. Applies to manufacturers, importers, and device user facilities.

Requires a 510(k) submission before commercial distribution of a device, demonstrating substantial equivalence to a legally marketed predicate device.

Governs the most stringent FDA device pathway, required for Class III high-risk devices. Requires valid scientific evidence of safety and effectiveness, including clinical data.

Allows investigational devices to be used in clinical studies to collect safety and effectiveness data in support of a PMA or 510(k) submission.

Governs methods, facilities and controls used in design, manufacture, packaging, labelling and servicing of finished devices. Effective February 2026, incorporates ISO 13485:2016 by reference.

The foundational US law authorizing FDA to regulate medical devices. Sections 513–520 govern device classification, premarket review, postmarket requirements, and enforcement.

Requires domestic and foreign manufacturers to register with FDA and list their devices annually. Foreign manufacturers must designate a US Agent.

The EU AI Act (Regulation 2024/1689) establishes a harmonised legal framework for artificial intelligence in the EU, with key implications for AI-enabled medical devices under MDR and IVDR.