Preparation of Medical Device Registration Dossier

Vocabulary flashcards created from the lecture notes on medical device registration, focusing on key terms and their definitions.

Health Sciences Authority (HSA)

The national regulatory authority responsible for overseeing the safety and efficacy of health products in Singapore.

GN-17 Guidance Document

A document providing guidelines for the registration of medical devices in Singapore.

GN-18 Guidance Document

A document focused on improving clarity and requirements for medical device submissions in Singapore.

CSDT

Common Submission Dossier Template; a standardized format for preparing medical device registration submissions.

Cybersecurity

Measures and evidence required to ensure the safety and security of connected medical devices.

Device Registration Submission Guides

Guidelines that outline the procedures and requirements for submitting registration applications for medical devices.

Technical Reference Documents

Detailed documents that provide in-depth information about technical requirements for product registration.

Bite-sized information

Concise and easily digestible pieces of information presented in the guidance documents.

Stability studies

Investigations to ensure the long-term safety and performance of medical devices under various conditions.

Instructions for Use (IFU)

Documentation that provides necessary information for the use of a medical device, including its format and medium.

Commercial marketing history

A record of the marketing events and approvals for medical devices across different jurisdictions.

Safety and performance related information

Data required to demonstrate the safety and effectiveness of medical devices.

Input request queries

Requests for additional information or clarification during the device registration review process.

Legend and pictorial representation

Visuals such as diagrams, photographs, or drawings used to illustrate the characteristics of medical devices.