India Regulatory ServicesMedical Device Regulatory Consultancy Services for India
- CDSCO
- Medical Devices Rules, 2017
All India regulatory services are delivered by HL Associates.
Our Services
Services We Offer in India
CDSCO manufacturing, import, trade and loan licences, plus audit and compliance support, provided by HL Associates.
All India services are delivered by HL Associates
Choose a service below to see the full details on the HL Associates website.
MD-05 License for Class A & B Devices
Secure CDSCO Form MD-05 manufacturing licenses for low-risk (Class A) and moderate-low-risk (Class B) medical devices in India with end-to-end audit readiness support.
Learn more MD-09 License for Class C & D Devices
Obtain Central CDSCO Form MD-09 manufacturing licenses for high-risk (Class C & Class D) medical devices with expert technical writing and liaison support.
Learn more Manufacturing Registration for Class A Non-Sterile & Non-Measurable Devices
Execute instant online CDSCO SUGAM portal registration for low-risk, non-sterile, and non-measurable Class A medical devices.
Learn more Additional Regulatory Services (MSC, FSC, NCC & NPPA)
Secure Market Standing Certificates (MSC), Free Sale Certificates (FSC), and ensure compliance with NPPA price control regulations.
Learn more MD-15 Import License for Class A, B, C & D Devices
Secure CDSCO Form MD-15 import licenses for foreign medical devices of all classes through an Authorized Agent in India.
Learn more MD-17 Import License for Testing & Training
Acquire CDSCO Form MD-17 licenses to import medical devices in limited quantities for laboratory testing, training, or clinical trials.
Learn more Import Registration for Class A Non-Sterile & Non-Measurable Devices
Register low-risk, non-sterile imported Class A medical devices via the online CDSCO portal for rapid customs clearance.
Learn more MD-42 Medical Device Trade License
Obtain Form MD-42 registration certificates to legally stock, exhibit, sell, or distribute medical devices in India.
Learn more MD-06 Loan License for Class A & B Devices
Manufacture Class A and Class B medical devices on contract utilizing a third-party licensed manufacturing plant.
Learn more MD-10 Loan License for Class C & D Devices
Contract manufacture moderate-high and high-risk Class C & D medical devices at licensed third-party plants.
Learn more ISO 13485 Documentation & Implementation
Achieve world-class Quality Management System (QMS) standard alignment with end-to-end ISO 13485:2016 implementation and mock audit services.
Learn more Gap Assessment & AMC Support
Ongoing compliance monitoring, periodic regulatory gap reviews, and annual maintenance contracts (AMC) to keep your facility audit-ready.
Learn more Plant Design & PMC Services
Turnkey cleanroom layouts, HVAC design, and comprehensive Project Management Consulting (PMC) for compliant medical device factories.
Learn more Why MedReg
Why choose MedReg
Expert consultants, thorough regulatory insight, and a seamless path to compliance, that’s our promise for your medical devices.
Project Strategy & Gap Assessment
Before a single page is drafted, we map your device to the right regulations and find every gap in your files, so your documentation is built once, built right and submission-ready.
Simplifying Complexity
We decode Complex regulatory requirements and define a clear, actionable pathway, to ensure your projects move forward efficiently and compliantly.
Comprehensive Understanding
We dive deep into your requirements, identifying all critical factors to ensure our solutions address every aspect of your regulatory needs.
Documentation You Can Trust
As experts, we provide clear, accurate, and accessible documentation, keeping you informed at every stage of your project.
Consultation
Compliance Made Simple – Start with a Free Consultation
Confidential & Audit-Proof
Request a consultation
Direct confidential advisory with senior CDSCO, CE MDR, and FDA specialists.
