Market Access

ZED Certification

ZED Certification for Medical Devices & IVDs

Enhance Quality. Build Trust. Strengthen Competitiveness.

India’s medical device and IVD (In Vitro Diagnostic) manufacturers are rapidly growing in both domestic and global markets. To support this momentum, the Government of India introduced the ZED (Zero Defect Zero Effect) Certification, encouraging manufacturers—especially MSMEs—to improve quality, adopt green practices, and become globally competitive.

At AQC, we help medical device and IVD manufacturers navigate the ZED Certification process, align with quality benchmarks, and unlock valuable government incentives.

What is ZED Certification?

The ZED Certification Scheme, launched under the Ministry of MSME, promotes the adoption of quality tools and environmental consciousness across the Indian manufacturing sector. For medical device and IVD manufacturers, ZED certification:

  • Demonstrates compliance with national and international quality standards
  • Builds confidence among healthcare providers, regulators, and patients
  • Facilitates smoother CDSCO registration and market access
  • Provides access to financial incentives, subsidies, and preferential procurement

Our ZED Certification Support Services Include:

Eligibility Assessment

  • We evaluate your organization’s current compliance level against ZED maturity models and ISO 13485 requirements for medical devices.

Documentation & Implementation Support

  • We guide you in preparing the required documents, process controls, SOPs, and quality manuals to meet ZED benchmarks and regulatory expectations.

Online Application & Portal Management

  • Our team handles the online application through the ZED portal, ensuring accuracy, speed, and full compliance.

Internal Audit & Gap Analysis

  • We conduct mock audits and gap assessments to ensure you are fully prepared for the official ZED certification audit.

Handholding During Assessment

  • From responding to assessor queries to final certification — we stay with you through every step.

Why ZED for Medical Devices & IVDs?

Medical device and diagnostic companies operate in highly regulated, safety-critical environments. ZED certification helps you:

Contract Manufacturers & Suppliers

Establish a culture of continual improvement and risk management

Medical Device & IVD Manufacturers

Increase readiness for CDSCO audits and ISO 13485:2016 certifications

Distributors & Importers

Gain an edge in public procurement platforms like GeM

EU Authorized Representatives

Enhance your reputation in both domestic and export markets

Key Benefits of ZED Certification:

  • Improved operational efficiency and product quality
  • Incentives & subsidies under various MSME schemes
  • Recognition in government procurement and tenders
  • Support for sustainability and zero-effect (eco-friendly) practices
  • Foundation for global certifications like ISO 13485, WHO-GMP, CE

Eligibility & Documents Required:

  • Valid Udyam Registration as MSME
  • PAN, GST, and Company Profile
  • CDSCO license (if applicable)
  • Quality Certifications (ISO 13485, if available)
  • Process flow documents, SOPs, quality manual
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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