Regulatory route is the gate
Menstrual cups are notified as Class A medical devices under CDSCO from 2022. Manufacturers need ISO 13485 certification and an MDR (Medical Device Rules) Form MD-5 licence — typical 8–12 month path including biocompatibility testing per ISO 10993-1, -5, -10.
Silicone grade matters
USP Class VI medical-grade platinum-cured silicone is the only acceptable substrate. Tin-cured variants are 20–25% cheaper but leach and discolour — not acceptable for intimate-contact products.
§ KEY TAKEAWAYS
- 01CDSCO Class A licence is 8–12 months — plan launch backwards from MD-5 grant
- 02Only USP Class VI platinum-cured silicone is acceptable
- 03Three-size SKU mix is the consumer norm (S/M/L)
- 04Sterilisation cup and pouch must be co-packed for compliance
§ GLOSSARY
Technical jargon, acronyms and scientific terms used in this file — decoded.
- CDSCO
- Central Drugs Standard Control Organisation — India's medical-device and drug regulator.
- Class A device
- Lowest-risk medical-device category under Indian MDR 2017; includes menstrual cups, gauze and tongue depressors.
- ISO 13485
- Quality management system standard specific to medical-device manufacturing.
- Platinum-cured silicone
- Silicone polymerised with a platinum catalyst — purer than tin-cured, USP Class VI compliant.
- ISO 10993
- Series of standards covering biological evaluation (cytotoxicity, sensitisation, irritation) of medical devices.