Purchasing 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: supplier qualification and evaluation criteria, purchase order specifications and acceptance criteria, supplier audit requirements, certificate of analysis requirements, incoming inspection procedures, material traceability documentation, and supplier agreement provisions. Reference Schedule 5 sections.