Regulatory Resources
Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools
India — Medical Devices Rules, 2017
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.
Download PDFSouth Korea — Medical Devices Act (Act No. 17007)
The South Korean Medical Devices Act (MFDS) governing approval, manufacturing, import, and post-market surveillance of medical devices. Last major amendment 2020.
Download PDFJapan PMD Act — Pharmaceuticals and Medical Devices Act
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.
Download PDFChina NMPA — Regulations for Supervision and Administration of Medical Devices (Order No. 739)
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).
Download PDFBrazil ANVISA — RDC No. 751/2022 — Medical Device Registration
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.
Download PDFUK Medical Devices Regulations 2002 (SI 2002/618)
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.
Download PDF21 CFR Part 801 — Device Labeling
Covers all labeling requirements for medical devices including labels affixed to the device and all descriptive and informational literature that accompanies it.
Download PDF21 CFR Part 803 — Medical Device Reporting (MDR)
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.
Download PDF21 CFR Part 807 Subpart E — Premarket Notification 510(k)
Requires a 510(k) submission before commercial distribution of a device, demonstrating substantial equivalence to a legally marketed predicate device.
Download PDF21 CFR Part 814 — Premarket Approval (PMA)
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.
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