Foxwyn · Healthcare Regulatory Services
CDSCO application support for drugs, cosmetics and medical devices.
Understand the applicable Indian regulatory pathway before you file. Foxwyn supports classification, documentation, SUGAM portal applications and inspection readiness for healthcare products.
What CDSCO regulates
Three product families. One coordinated pathway.
The applicable rules, authority and documentation depend on your product and activity. We help you identify the correct route before you invest in an application.
Medical Devices
Registration and licensing support under the Medical Device Rules 2017. Devices are classified by risk — Class A (low), Class B (low-moderate), Class C (moderate-high) and Class D (high) — and the class determines the licensing authority and documentation depth.
- Risk-class identification (A–D)
- Import and manufacturing licence applications
- Device Master File and Plant Master File preparation
- Notified-body audit coordination where applicable
Drugs & Pharmaceuticals
Application support for drug manufacturing, sale and import licences. Manufacturing licences are issued by state licensing authorities, while certain categories — such as new drugs and clinical trials — involve the central authority.
- State manufacturing and sale licence applications
- Import registration and licence coordination
- New drug and clinical trial application support
- GMP documentation aligned to Schedule M
Cosmetics
Licensing support for cosmetic manufacturing and import under the Drugs and Cosmetics Act and the Cosmetics Rules 2020, including labelling and ingredient-compliance review.
- Manufacturing licence applications
- Import registration for cosmetics
- Labelling and ingredient review
- GMP alignment for cosmetic premises
Typical process
From classification to licence handover.
- 01
Product and activity review — what you make, import or sell, and where
- 02
Classification and pathway identification — risk class, applicable rules and competent authority
- 03
Document checklist — master files, site details, quality documentation
- 04
Application preparation and filing via the SUGAM portal or state system
- 05
Query-response and inspection-readiness support
- 06
Licence handover and renewal planning
Central or state — which authority?
Many drug and cosmetic licences are issued by state licensing authorities, while CDSCO handles categories such as new drugs, clinical trials, and higher-risk medical devices. Class A and B device manufacturing licences are processed through state authorities; Class C and D involve the central authority. We map your product to the correct authority before filing.
Documentation we help you prepare
- Device Master File and Plant Master File
- Site, premises and technical-staff details
- Quality management documentation (ISO 13485 alignment where applicable)
- Test reports and standards-conformance evidence
- Labels, artwork and instructions for use
- Authorised-agent and importer documentation
Licences and registrations are granted by CDSCO, state licensing authorities or notified bodies following their own review. Government fees are separate and payable as prescribed. Foxwyn provides consultancy and application support only — we do not guarantee approvals or timelines. Official information: cdsco.gov.in
Questions
CDSCO FAQs
Selling into the US as well? The pathways are separate — see our FDA / USFDA services
Planning a drug, cosmetic or medical device application?
Share your product, activity and intended market. We'll identify the applicable pathway, authority and documentation before you file.