Regulatory Support for In Vitro Diagnostic Devices
IVD Medical Device Registration
In Vitro Diagnostic (IVD) medical devices have specific classification, documentation and registration requirements under Malaysia’s medical device regulatory framework.
T T Medical provides specialised IVD medical device registration services in Malaysia, helping manufacturers prepare and manage their applications with the Medical Device Authority (MDA).
Expert Support for IVD Registration
IVD Registration Support in Malaysia
IVD medical devices are regulated under the Medical Device Act 2012 (Act 737) and must follow the applicable MDA registration requirements before being placed on the Malaysian market. The regulatory pathway can vary depending on the device’s intended purpose, risk classification and supporting technical documentation. Our regulatory specialists help manufacturers identify the appropriate pathway and navigate the IVD registration process with greater clarity.
Our IVD Registration Support
IVD Classification
Review the intended purpose and characteristics of the IVD device to determine the appropriate regulatory classification.
Product Grouping
Assess the appropriate grouping of IVD products for the registration application based on current regulatory requirements.
Technical Documentation
Review and prepare applicable technical, performance and supporting documentation for the registration process.
MDA Submission Support
Support the preparation, submission and management of the IVD medical device registration application with the MDA.
A Clear Path from Review to Registration
Our IVD Registration Process
01
IVD Regulatory Review
We review the product, intended purpose, manufacturer information and available regulatory documentation.
02
Classification & Grouping
Our team identifies the appropriate IVD classification and registration grouping.
03
Documentation Preparation
We review and organise the required regulatory and technical documentation for submission.
04
Registration & Follow-Up
We support the application process and assist with regulatory queries until the registration process is completed.
Expert Regulatory Guidance
Need Regulatory Support in Malaysia?
Speak with our experienced regulatory team to identify the right registration or representation service for your medical device and receive practical guidance throughout the Malaysian regulatory process.
