Draft Medical Device Consultant Certification Scheme from LSSSDC, for public comments
Who is LSSSDC?
The Life Sciences Sector Skill Development Council (LSSSDC) is a premier, not-for-profit skilling body operational under the aegis of the Ministry of Skill Development and Entrepreneurship (MSDE), Government of India. It is anchored by the National Skill Development Corporation (NSDC) and promoted by leading industry bodies like the Confederation of Indian Industry (CII) in partnership with the pharmaceutical, biotechnology, and medical device industries. LSSSDC’s primary mandate is to map the skill gaps across India’s life sciences landscape and develop high-quality, certified, and globally competitive human resources to support sector growth.
Medical Device Consultant Certification Scheme (MDCCS)
1. Purpose & Core Objective
As India’s medical technology footprint rapidly expands, navigating complex domestic and international regulatory compliance, quality control, and testing environments has become critical. To match this growth, the industry requires highly skilled advisory professionals.
The primary purpose of the Medical Device Consultant Certification Scheme (MDCCS) is to establish a rigorous, uniform, and globally recognized benchmark for certifying individual Medical Device Consultants in India. By aligning this scheme with ISO/IEC 17024:2012 (the international standard for bodies operating certification of persons), LSSSDC aims to build an objective ecosystem that fosters stakeholder confidence and ensures high regulatory compliance across the industry.
2. Overview of Scheme Details
- The Framework: LSSSDC acts as the primary “Scheme Owner.” It defines the blueprint, rules, and operational guidelines that Personnel Certification Bodies (PrCBs) must follow to evaluate candidates.
- Harmonization: The scheme ensures that no matter where or by whom a consultant is evaluated, the baseline requirements remain absolutely identical, removing subjective loopholes from the testing process.
- The Value Addition: For consultants, it provides formal market credibility. For medical device manufacturers and regulatory bodies, it acts as an immediate assurance of a professional’s competence.
3. What the Competence Standard Says
The Competence Standard defines what a professional must know and be capable of doing to successfully practice as a certified consultant. It covers:
- Minimum Competence Thresholds: Explicit benchmarks establishing the standard baseline of technical knowledge and practical experience a professional must have.
- Impartial Assessment: Rules outlining structured testing pathways—ensuring individual capabilities are measured fairly via verified evidence and testing formats.
- Regulatory & Quality Standards: Mastery over regional and international compliance mandates, quality management systems (like ISO 13485), risk assessments, and clinical evaluation pathways.
Official Resource Links
Because these draft policies are currently undergoing a registration-gated review process, you can access the primary documentation portals directly on the official LSSSDC platform:
https://www.lsssdc.in/page/downloadPdf#mdccs-details
Share Your Feedback!
Attention Public, Industry Stakeholders, and Medical Device Professionals!
Your expertise is vital in shaping the future of medical tech regulation and consulting in India. The LSSSDC invites active feedback, critiques, and recommendations on this draft framework before it is finalized into official policy.
You can share your feedback by using the form lister here :
https://docs.google.com/forms/d/e/1FAIpQLSd2fhubNYklhsYNNmnnxcusgRcOR71p8Zq4ISLTqoj2daMw-A/viewform
Consultation Window:
Opens: June 23, 2026
Closes: July 22, 2026
Please take a few moments to review the draft manuals and share your insights to help refine this ecosystem.