Programme Introduction
About this programme
💊 Pharmacy Practice
✅ Regulatory & Clinical
📋 Case-Based Learning
Medical devices sold, manufactured or imported in India are regulated under the Medical Devices Rules, 2017, framed under the Drugs and Cosmetics Act, 1940, and administered by the Central Drugs Standard Control Organization (CDSCO). The rules classify devices by risk, set licensing requirements for manufacture and import, and prescribe quality management expectations for the entire product lifecycle.
As India’s medical technology sector grows, pharmacy and regulatory affairs professionals are increasingly expected to interpret device classification correctly, prepare licensing dossiers, and align manufacturing quality systems with CDSCO expectations and comparable global norms such as those of the USFDA and the European Union.
TerraLeap’s programme breaks the Medical Devices Rules, 2017 into practical, workable knowledge — how devices are classified into Class A, B, C and D, what each licence application requires, and how a quality management system is assessed and maintained over a device’s lifecycle.
Learners finish able to identify the correct regulatory pathway for a given device and to recognise the documentation a licensing authority will expect to see.
Clinical and regulatory expertise — built for real pharmacy practice.
Programme Scope
What this programme covers
The course follows a medical device from classification through licensing, quality systems and post-market obligations.
📊
Risk-based classification
How devices are placed into Class A, B, C or D based on intended use and risk.
📄
Licensing requirements
Application routes for manufacturing, import, distribution and sale licences.
🔬
Clinical investigation
Performance evaluation requirements before a higher-risk device reaches market.
✅
Quality management systems
What a QMS must demonstrate to satisfy licensing authorities on an ongoing basis.
🏷️
Labelling & import controls
Requirements for accurate labelling and controlled entry of imported devices.
🌍
Global regulatory alignment
How Indian device rules compare with USFDA and EU regulatory approaches.
Learning Objectives
What you will achieve
The programme is built around the practical questions a regulatory affairs professional faces when a device moves toward the Indian market.
By the end of the course you will be able to:
01
Classify a medical device correctly into its risk-based category under the 2017 rules.
02
Identify the required licence type for manufacturing, import, distribution or sale.
03
Outline clinical investigation requirements for higher-risk device categories.
04
Assess a quality management system against CDSCO expectations across the device lifecycle.
05
Prepare compliant labelling and import documentation for a device consignment.
06
Compare Indian device regulation with USFDA and EU frameworks to spot gaps in a submission.
Target Audience
Who can enroll
This medical device regulations course is intended for pharmacy and regulatory affairs professionals who need to classify devices correctly and navigate CDSCO licensing and quality system requirements.
It is equally valuable for anyone working on the manufacturing, import or quality assurance side of the medical device industry in India.
🎓
Pharmacy graduates moving into regulatory affairs careers.
📋
Regulatory affairs executives managing device licensing applications.
🏭
Medical device manufacturing and quality assurance staff.
📦
Import and distribution teams handling device compliance.
📚
Life-sciences students preparing for careers in medical device regulation.
Programme Certification
Your certificate
Upon successful completion of this programme, you will receive a digital certificate recognising your achievement and the competencies you have acquired throughout the course.
Certificates for TerraLeap programmes are issued and signed by authorised TerraLeap representatives. For programmes delivered in collaboration with universities, institutions, or industry organisations, certificates are jointly issued and co-signed by authorised representatives of both TerraLeap and the respective partner.
Each certificate carries a unique Certificate ID and QR code to enable instant authenticity verification — making it easy to share with employers, licensing bodies, or professional networks as evidence of your learning.
Note on scope. TerraLeap certificates confirm successful completion of the respective programme and recognise your professional development and continuing education. They do not constitute a professional licence or regulatory authorisation unless explicitly stated in the programme description.
TERRALEAP
Certificate ID
TL-2026-AB7K3X9P
Official
Seal
Certificate of Completion
Successfully Completed
Awarded in recognition of academic achievement
This is to certify that
XXXXX
has successfully completed the prescribed course of study, demonstrating commitment, diligence, and proficiency in
Medical Device Regulations in India
and is hereby awarded this certificate by TerraLeap, recognising the candidate's mastery of the syllabus and successful evaluation.