RAPath IN
India Medical Device Regulatory Reference
RAPath IN is a plain English reference for medical device regulation in India under the Drugs and Cosmetics Act 1940 (D&C Act) and the Medical Devices Rules 2017 (MDR 2017). It is designed for regulatory affairs professionals, manufacturers, importers, distributors, and consultants who need to find and understand CDSCO requirements quickly.
This site does not replace official CDSCO sources. Every page links back to the authoritative legislative text or official guidance. Think of RAPath IN as a structured, searchable index that helps you find what you need — then points you to the official source to verify it.
Who this site is for
Regulatory affairs professionals and consultants — a well-structured reference for requirements you navigate daily, with every claim linked to its legislative source.
Manufacturers (Indian and overseas) — understand what CDSCO requires of you, and how it relates to frameworks you may already know (EU MDR, TGA, FDA, HSA).
Importers and distributors — understand your import licence, Indian Authorised Representative (IAR) obligations, SUGAM portal workflow, and post-market responsibilities.
Anyone new to India medical device regulation — start with Start Here for a guided introduction to the framework.
How to use this site
The site is structured around the regulatory lifecycle of a medical device in India:
| Section | What it covers |
|---|---|
| Start Here | Definitions, D&C Act, CDSCO vs SLA split, framework overview, device lifecycle |
| Pre-Market | Classification, import registration (MD-14/15), manufacturing licence, technical docs, clinical investigation |
| Post-Market | MDVP vigilance, PMS, recalls, labelling, UDI |
| Quality System (GMP) | Schedule 5 GMP, ICMED, ISO 13485, inspections, PLI scheme |
| Import, Export & SUGAM | Import licence, IAR, SUGAM portal, export certificates |
| Legislation & Regulations | D&C Act, MDR 2017 all chapters & schedules, ND&CT Rules, amendments |
| Guidance Documents | CDSCO guidance, BIS standards, SUGAM forms (MD-1 to MD-48), fee schedule |
| Special Access & Designations | Compassionate use, emergency authorisation, AYUSH borderline devices |
| International & Comparison | IMDRF, India vs FDA/TGA/EU, MRA status, multi-market strategy |
| Enforcement & Compliance | CDSCO inspections, show-cause notices, suspension, appeals |
| Digital Health & SaMD | SaMD, AI/ML devices, telemedicine, NDHM interface |
| What's New | Recent changes, new circulars, draft rules, UDI & PLI tracker |
What this site is not
- Not legal or regulatory advice. Always consult a qualified regulatory professional before making submission or compliance decisions.
- Not affiliated with CDSCO or the Government of India. This site is not produced by or on behalf of the Central Drugs Standard Control Organisation.
- Not a substitute for official sources. Every page links to the relevant CDSCO guidance, MDR 2017 rule, or D&C Act provision — always verify there.
Content currency
This site was last reviewed in May 2026. CDSCO guidance and regulations change frequently. Check What's New for recent updates.
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official CDSCO sources before making regulatory decisio