The Standards & Regulation Codex
The rules a condom has to pass, everywhere it is sold
Condoms are a regulated medical device in every major market. This codex documents the standard that governs manufacture, the regulator that enforces it, and how they differ by jurisdiction.
Last verified: August 2026
6 entries planned
0 published
Read this before using anything in this codex
This codex documents public regulatory frameworks for general understanding. It is not legal or regulatory advice. Manufacturers and importers must confirm current requirements directly with the relevant regulatory body before bringing any product to market.
Planned entries
Six standards and regulatory frameworks
ISO 4074The core international manufacturing standardPending
ASTM D3492United States national specificationPending
WHO/UNFPA specificationProcurement and prequalification standardPending
US FDA 21 CFR 884.5300Class II medical device classificationPending
EU MDR 2017/745CE marking and European market accessPending
National regulators worldwideIndia CDSCO/BIS, UK MHRA, Australia TGA, Japan PMDA, China NMPA, Brazil ANVISAPending
Sourcing for this codex
Primary regulatory text only
ISO 4074:2026 — iso.org, ISO/TC 157
US Code of Federal Regulations — 21 CFR 884.5300, via the eCFR and FDA 510(k) database
EU Medical Device Regulation — Regulation (EU) 2017/745, official text
WHO Technical Report Series 1025 — Annexes 9 and 10, who.int
National regulator publications — cited directly from each body's own official site
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