Indian MDR — Medical Devices Rules, 2017

India's Medical Devices Rules, 2017 (effective 1 January 2018). Covers risk classification, CDSCO/SLA licensing forms (MD-5, MD-9, MD-15, MD-42), Fifth Schedule QMS, labelling, clinical investigation, MvPI vigilance, recalls, IVDs and recent amendments.

Modules

20 modules

Category

Regulatory

Pass mark

80%

Certificate

Free, instant

Audience

Regulatory affairs, quality and clinical teams placing medical devices and IVDs on the Indian market.

• Understand introduction to the Medical Devices Rules, 2017
• Understand regulatory Authorities: CDSCO, CLA, SLA and the DCG(I)
• Understand key Definitions under MDR 2017
• Understand risk Classification (Class A, B, C, D)
• Understand applying the First Schedule Classification Rules
• Understand licensing Pathways at a Glance
• Understand manufacturing Licence for Class A & B Devices (Form MD-5)
• Understand manufacturing Licence for Class C & D Devices (Form MD-9)

• Navigate global regulations

  Decode regional regulatory frameworks and learn what authorities expect from manufacturers.

• Stay audit-ready

  Understand the exact clauses and expectations auditors and regulators check during inspections.

• Boost your career

  A recognised certificate of completion that you can add to your CV and LinkedIn profile.

• Plain-language modules

  Complex requirements broken into bite-sized, easy-to-remember lessons with examples.

• Free assessment & certificate

  Take the timed exam and earn a personalised, verifiable certificate at no cost.

• Regulatory affairs, quality and clinical teams placing medical devices and IVDs on the Indian market

• 20 plain-language modules

  Bite-sized lessons with examples, memory aids and key terms.

• Timed assessment

  Multiple-choice exam with 80% pass mark. Retake anytime.

• Verifiable certificate

  Personalised PDF with a unique verification code — shareable on LinkedIn.

• Downloadable resources

  Reference material and attachments available inside modules.

• Lifetime access

  Learn at your own pace — revisit modules whenever you need to refresh.

• Aligned to standards

  Content mapped to internationally recognised medical device standards and regulations.

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