Guidance on Preparation of a Product Registration Submission for General Medical Devices

These flashcards cover key terms and definitions related to the preparation of a product registration submission for general medical devices.

Adverse Effect

Any debilitating, harmful, toxic or detrimental effect that a medical device may have on human health.

Adverse Event

Any occurrence that reveals a defect in a medical device or that concerns an adverse effect.

Field Safety Corrective Action

Actions taken to reduce risks associated with a medical device, including modifications or return of the device.

Medical Device

A product used for medical purposes as described in the relevant health regulations.

Registrar

A person who applies for and obtains the registration of a health product.

ASEAN CSDT

ASEAN Common Submission Dossier Template, a template for medical device submissions.

Design Verification & Validation

Processes to ensure a medical device meets design specifications and is validated for its intended use.

Clinical Evidence

Data supporting the safety and effectiveness of a medical device, often from clinical studies or literature reviews.

Essential Principles

Key safety and performance criteria that medical devices must conform to.

Risk Analysis

Assessment identifying risks associated with a medical device and measures to mitigate these risks.