Medical Devices Rules 2017 Schedule 3 QMS Audit Checklist
This checklist covers compliance requirements under Medical Devices Rules 2017 and applicable Indian regulations for healthcare operations. Non-compliance can result in cancellation of manufacturing licence and penalties up to ₹10 lakh under Section 27 of the Drugs & Cosmetics Act 1940.
- Industry: Healthcare
- Frequency: Quarterly
- Estimated Time: 25-35 minutes
- Role: Quality Director
- Total Items: 20
- Compliance: Medical Devices Rules 2017, CDSCO MD Guidance, IS 13485, MDR 2017 Schedule 3
CDSCO Licence & GMP Registration
Verify Drugs & Cosmetics Act 1940 manufacturing licence and Schedule M GMP registration.
- Is the manufacturing licence (Form 25 or 28) valid and current for all products manufactured?
- Is a qualified Technical Staff person (B.Pharm or equivalent) appointed and approved by the licencing authority?
- Is the manufacturing site registered with CDSCO for export and does it comply with Schedule M GMP requirements?
- Attach photo of manufacturing licence Form 25/28, Technical Staff appointment, and CDSCO registration:
Premises, Equipment & Utilities Compliance
Verify GMP premises qualification, utilities, and equipment calibration per Schedule M.
- Are all premises, equipment, and utilities qualified per Schedule M GMP and validation master plan?
- Is the water system (Purified Water or WFI) tested per pharmacopoeial limits with records maintained?
- Are all analytical instruments calibrated with valid calibration certificates on file?
- Attach photo of cleanroom qualification, water system test results, and calibration certificates:
Batch Records & OOS Investigation
Verify BMR completeness, OOS investigation compliance, and QA release per Schedule M.
- Is the batch manufacturing record (BMR) complete, reviewed by QA, and available for every batch?
- Is the out-of-specification (OOS) procedure followed and all OOS investigations documented?
- Overall cGMP production and QA compliance status:
- Attach photo of batch manufacturing record, OOS investigation file, and QA release stamp:
CAPA, Complaints & Pharmacovigilance
Verify CAPA system effectiveness and ADR/pharmacovigilance compliance per CDSCO requirements.
- Is the CAPA system effectively identifying, investigating, and preventing recurrence of quality issues?
- Are product complaints investigated and Adverse Drug Reactions (ADRs) reported to CDSCO PvPI portal?
- Number of open CAPAs beyond target closure date:
- Quality Director or Head of Quality certification:
Corrective Actions & Inspector Sign-Off
Document all deficiencies and assign corrective actions. POPProbe auto-assigns these to team members, generates a signed PDF report instantly, and tracks compliance status across all locations. -> Start free, no credit card required
- List all deficiencies identified in this inspection:
- Overall compliance status?
- Corrective actions assigned to (name and department):
- Inspector digital signature and date:
Related Health Services Checklists
- New Drugs & Clinical Trial Rules 2019 GCP Compliance Audit Checklist
- ISO 13485:2016 & Medical Devices Rules 2017 India QMS Audit
- New Drugs & Clinical Trials Rules 2019 Clinical Site GCP Inspection
- Drugs & Cosmetics Act Blood Bank Annual Licence Renewal Audit
- BMW Management Rules 2016 Healthcare Biomedical Waste Compliance
- NABH Hospital Accreditation Standards 5th Edition Compliance Audit
- NABH Standards HIC Infection Prevention & Control Audit Checklist
- NABH Standards MM Medication Management Safety Audit Checklist
Related Pharmaceutical Checklists
- New Drugs & Clinical Trial Rules 2019 GCP Compliance Audit Checklist - FREE Download
- ISO 13485:2016 & Medical Devices Rules 2017 India QMS Audit - FREE Download
- New Drugs & Clinical Trials Rules 2019 Clinical Site GCP Inspection - FREE Download
- Drugs & Cosmetics Act Blood Bank Annual Licence Renewal Audit - FREE Download
- Medical Devices Rules 2017 Post-Market Surveillance Plan Audit - FREE Download
- Clinical Establishments Act 2010 Hospital Pharmacy Compliance Audit - FREE Download
- Drugs & Cosmetics Rules Schedule H1 High-Risk Drug Sales Compliance - FREE Download
- AERB & BARC Radiopharmacy Nuclear Medicine Safety Compliance Audit - FREE Download
- CDSCO Combination Products Drug-Device Regulatory Compliance Audit - FREE Download
- CDSCO CTD Module 4 Non-Clinical Study Reports Compliance Audit - FREE Download
Why Use This Medical Devices Rules 2017 Schedule 3 QMS Audit Checklist?
This medical devices rules 2017 schedule 3 qms audit checklist helps healthcare teams maintain compliance and operational excellence. Designed for quality director professionals, this checklist covers 20 critical inspection points across 5 sections. Recommended frequency: quarterly.
Ensures compliance with Medical Devices Rules 2017, CDSCO MD Guidance, IS 13485, MDR 2017 Schedule 3. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Medical Devices Rules 2017 Schedule 3 QMS Audit Checklist cover?
This checklist covers 20 inspection items across 5 sections: CDSCO Licence & GMP Registration, Premises, Equipment & Utilities Compliance, Batch Records & OOS Investigation, CAPA, Complaints & Pharmacovigilance, Corrective Actions & Inspector Sign-Off. It is designed for healthcare operations and compliance.
How often should this checklist be completed?
This checklist should be completed quarterly. Each completion takes approximately 25-35 minutes.
Who should use this Medical Devices Rules 2017 Schedule 3 QMS Audit Checklist?
This checklist is designed for Quality Director professionals in the healthcare industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.