Management Responsibility

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: quality policy establishment, management commitment to QMS, definition of organizational responsibilities, management review frequency and scope, resource allocation requirements, management representative designation, and internal communication procedures. Reference specific Schedule 5 sections.