The Malaysia Medical Device Authority (MDA) provides some guidance on grouping. Grouping allows for a simplification of the application process, which in turn, is more cost effective and time saving for the manufacturer. Grouping in Malaysia is harmonized with the ASEAN MDD and is centered on three basic rules:
1 generic proprietary name;
1 manufacturer; and
1 common intended purpose.
As in other ASEAN MDD harmonized countries, applications can be submitted under one the following grouping categories:
IVD Test Kit
Grouping Definitions and Examples
A Single medical device ranges in package size and/or number of units and complies with the three rules.
A Family consists of products that have a common risk classification, manufacturer, generic proprietary name, intended use, design, and manufacturing process, but may slightly differ from each other. Permissible variants can also apply (see below).
Permissible Variants for Family
Isotope activity level
Viscosity (The change in viscosity is solely due to changes in the concentration of the constituent material)
Type of device mounting (e.g., ceiling mount, wall mount, or standing)
Dimensional design differences due to pediatric versus adult use (the differences due to the different patient population are permissible e.g., volume and length
i) Number of lumens in catheter
ii) Material of catheter: PVC (polyvinylchloride), PU (polyurethane), nylon, and silicone
iii) Curvature (straight or pigtail) Polymer products with or without DEPH stent delivery system that is over the wire or through the scope
ii) UV protection
Material of bracket
i) Rotational speed
ii) Material of handpiece
i) Electrode Spacing
ii) Number of electrodes
i) Presence of injection port
ii) Presence of safety features
IVD Rapid Tests
i) Different assembly format: cassette, midstream, or strip
IVD Urinalysis Strips
i) Different combination of testing configurations
With or without DEHP
i) Delivery system, that is over the wire or through the scope
i) Number of strands
i) Design of jaw, handle, or needle
A System contains accessories that work in combination with the medical device to achieve a common intended purpose and complies with the three rules. The labelling, Instructions for Use (IFU), and other brochures all indicate that the medical devices are meant to be a system as well.
A Set consists of 2 or more medical devices that are imported and sold in the same packaging (different manufacturers are allowed) with the same intended purpose. It must also be sold under the same proprietary set name. Risk classification is dependent on the medical device with the highest risk.
IVD Test Kits contain reagents and/or articles and are labelled as an IVD test kit and are meant to be used in combination for a common intended purpose. The labelling, Instructions for Use (IFU), and other brochures all indicate that the medical devices are meant to be a IVD test kit as well. They also have a common manufacturer and a single proprietary name. These kits do not include analyzers.
And IVD Cluster contain in-vitro reagents and/or articles and have a common manufacturer and test methodology but may have different intended use. These articles must also have risk classification A or B. It may contain two different test kits, reagents, and other articles.
Contact Asia Actual for more information about Malaysia grouping requirements.