Capa

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 CAPA requirements such as: procedures for investigating complaints and nonconformities, root cause analysis methodologies, corrective action implementation timelines, preventive action triggers, documentation requirements for CAPA records, and management review of CAPA effectiveness. Reference specific Schedule 5 sections that address these elements.