Document Record Controls

This section covers the Schedule 5 requirements applicable to medical device manufacturers in India for this QMS element.

Schedule 5 Part I applies to all manufacturers (Class A–D). Part II applies to Class C and D manufacturers and includes additional requirements aligned with ISO 13485:2016.

Official source: Medical Devices Rules 2017, Schedule 5

Add a section detailing specific requirements such as: document approval and authorization procedures, version control and change tracking, record retention periods by document type, access controls and traceability, document archival procedures, obsolete document handling, and electronic record management requirements. Include specific Schedule 5 references.