Guidance documents for medical devices

Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in medical devices.

Product Registration

Product Registration Guidelines

Unique Device Identification (UDI) Submission Guidelines

IVD Analysers

Medical Devices Product Classification

Product Specific Regulatory Guidelines

Product Registration Dossier Requirements

Medical Devices Risk Classification

Grouping of Medical Devices

Labelling of Medical Devices

Clinical Evaluation

Declaration of Conformity

Essential Principles for Safety and Performance

Archived Regulatory Guidances