Malaysia

Malaysia Medical Device Grouping

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:

Single
Family
System
Set
IVD Test Kit
IVD Cluster

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

Color

Diameter

Flexibility

Gauge

Holding force

Isotope activity level

Length

Memory storage

Print capability

Radiopacity

Shape

Size

Volume

Width

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

Specific Products	Permissible Variants
Antibiotic Test	i) Concentrations
Catheter	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
Condoms	i) Texture ii) Flavor
Contact Lens	i) Diopter ii) UV protection iii) Tinting
Dental Brackets	Material of bracket
Dental Handpieces	i) Rotational speed ii) Material of handpiece
Electrophysiological Catheter	i) Electrode Spacing ii) Number of electrodes
IV Cannula	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
Polymer Products	With or without DEHP
Stent	i) Delivery system, that is over the wire or through the scope
Suture	i) Number of strands ii) Pledgets
Suture Passer	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.