Malaysia Device Registration: Classify Before You Register

By Kandace Nguyen Fu, Senior Vice President of Pacific Bridge Medical

Classifying your product as a medical device in Malaysia is an important first step before registering the device. Malaysia’s regulatory system is relatively new and undergoing many changes, so it is crucial to stay up-to-date in order to properly register your products.

MDA Classification Review Criteria

In 2016, the Malaysia Medical Device Administration (MDA) implemented a new formal review system in order to classify products as a “medical device” or a “non-medical device” (i.e. drug product). The criteria that the MDA will use to determine this classification is the following:

1. The primary intended purpose of the product.
2. The primary mode or principal of action that the product utilizes to achieve the claimed effect. Typically, medical devices achieve their effects through physical or mechanical actions, while drugs achieve their effects through metabolic, chemical, or other related actions.
3. The active ingredients, indications, and pharmaceutical dosage information about this product (if available). This information is typically only provided for pharmaceutical products, and thus would push the product towards classification as a non-medical device.
4. The classification of the product, or of similar products, in the “reference countries”, which are the US, EU, Canada, Australia, and Japan.

Click here to review the step-by-step product classification process

Before submitting the application form, the following information from these four categories must be carefully compiled:

1. Applicant details, including applicant name and name of the Authorized Representative (AR) or distributor/importer in Malaysia
2. Product information, including the classification review criteria highlighted above, and other criteria such as product formulation (if applicable), and status of products in the “reference” countries”
3. Supporting documents, including the product label, product leaflet/brochure, and other relevant documents
4. Applicant declaration

Completing the Formal Review Process is a Valuable Investment

Due to recent changes implemented in Malaysia’s Medical Devices Act, the MDA has accumulated a severe backlog of applications that they must review before they can begin reviewing new medical devices. The backlog consists of devices that are already in the Malaysia market and devices from a “transition list” established in the act. Due to this backlog, it may take several months up to a year for the MDA to review the application for a new medical device. At this time, PBM is not able to advise when the registration of new products will begin. Therefore, PBM highly recommends that you do NOT attempt to classify your product yourself, and subsequently proceed with the registration. The regulatory and document pathways for device submissions and drug submissions vary greatly, so completing the formal classification process is the only way to guarantee that your product is classified correctly. Though this step will initially add time to the process, it will take significantly less time, money, and resources than attempting to register for the incorrect classification, and having to start the process over for the correct classification.

For example, if you believe that your product is classified as a device without confirming this through the product classification process, you would proceed with compiling the dossier and other required documents for device registration in Malaysia, which would take about 3 months to complete. Upon paying for and submitting the application, you would have to wait several months (up to a year) for the MDA to finish reviewing the backlog of applications before your application is reviewed. Then, you would have to wait several more months for the MDA to review your application and inform you that your product was incorrectly classified. You would then have to restart this whole process of registering your product as a drug, which would require you to compile a different dossier and other requirements. Not only would this be expensive, but also a significant waste of time and effort.

While we understand the appeal of skipping the formal product classification step, the MDA is still in an evolving stage, making many processes confusing and difficult to navigate. PBM’s 29 years of experience and intricate knowledge of the MDA’s requirements and regulations will ensure that your registration process will occur as quickly and smoothly as possible.