Acheive seamless medical device registration in Malaysia and ASEAN member states with our expert end-to-end assistance. We support manufacturer of medical devices and IVDs to address challenges reguatory issues.
Malaysia presents a thriving and dynamic market for foreign medical device within Southeast Asia. Complying with Section 5(1) of the Medical Device Act 2012 (Act 737), it is mandatory to obtain market authorization in Malaysia by registering the product under the aforementioned Act. This registration process is a prerequisite before importing, exporting, or introducing the medical device whether manufactured domestically or not, must be registered with the Medical Device Authority (MDA) before they can be supplied in Malaysia.
To facilitate this procedure, manufacturers must submit application for the registration of their medical device, adhering to Act 737’s stipulations and complying with the directive outlined in the Medical Device Regulation 2012 issue by the government authority. The registration process is exclusively conducted through the MeDC@st2.0+ (Medical Device Centralized Online Application System), necessitating the involvement of a local Authorized Representative who will undertake the registration on behalf of the manufacturer.
In compliance with Malaysia regulations, the process of obtaining an establishment license, registering a medical device, and applying for an export permit is restricted to companies that are locally registered with the Companies Commission of Malaysia (SSM). Upon successful registration with SSM, a company must create a singular account on MeDC@St2.0+. This platform serves as the gateway for initiating the application for an Establishment License, with each license type tailored to the specific activities conducted by the company, including Manufacturer’s License, Importer’s License, Distributor’s License, or Authorized Representative’s License.
For foreign manufacturers seeking to enter the Malaysian market, there are three (3) possible approaches to register their medical device in Malaysia:
MeDC@St, short for Medical Device Centralised Online Application System, is an advanced online platform established by the Malaysian Medical Device Authority (MDA) to manage diverse applications related to Establishment Licensing, Medical Device Registration, and Export Permit.
Within Malaysia’s medical device industry, including manufacturers, importers, exporters, distributors, and Authorized Representatives, it is compulsory to utilize the MeDC@St system for the streamlined and efficient submission of various applications, particularly for the registration of medical devices with the MDA.
This digital platform enhances regulatory interactions, promotes transparency, accessibility, and organizational efficiency, ultimately contributing to the safety and quality of medical devices available in the Malaysian market.
Since its initial launch in July 2013, MeDC@St has undergone significant upgrades, culminating in MeDC@St 2.0 in January 2019. Building upon this foundation, we are delighted to announce the introduction of MeDC@St 2.0+ effective from 1st February 2022. This latest version represents a substantial enhancement to our online application system, incorporating a range of additional features meticulously designed to enhance user experience and streamline processes. Notably, MeDC@St 2.0+ introduces the Change Notification Module, along with the Device Study sub-module (under Clinical Research module), Clinical Research Use sub-module (under Clinical Research module), Demonstration for Marketing Notification, and Payment module. These new functionalities exemplify our unwavering commitment to continuous quality improvement and further exemplify our dedication to providing exemplary services to our valued users.
The term “medical device” encompasses any product utilized in the healthcare sector for the purpose of diagnosing, preventing, monitoring, or treating illnesses or disabilities, with the exception of drugs. This comprehensive definition includes in-vitro diagnostics (IVDs) as well. It is important to emphasize that any medical device, whether classified as a traditional medical device or an in-vitro diagnostic, must adhere to the regulations outlined in Section 2 of Act 737, as specified in the guidance document MDA/GD/0006. Prior to importation, exportation, or introduction into the market, all medical devices are required to undergo registration in accordance with the Act.
*For the purpose of clarity, this website will refer to medical devices as encompassing both general medical devices and in-vitro diagnostics.
The classification of General Medical Devices is determined by evaluating the level of risk associated with their usage, taking into consideration the potential impact on patients, users, and other individuals. The assessment of risk for a specific device depends on several key factors:
- Its intended purpose
- Effectiveness of Risk Management Techniques
- Its intended user(s)
- Its mode of operation
- Technologies
- Contact duration with the body.
- Level of invasiveness and site within the body.
- Delivery of medicines or energy to the patient.
- Intentional biological effects on the body.
- Intended action on the human body.
- Local or systemic effects.
- Contact with injured skin.
- Diagnostic or treatment purpose.
- Reusability of the device.
- Combination with other devices.
In Malaysia, the registration process for General Medical devices involves classification into four distinct classes: Class A, B, C, and D. Each class corresponds to a specific risk level, and examples of devices falling under each class are provided in the table below:
In the case of In-Vitro Diagnostic (IVD) Medical Devices, the classification process is based on a set of rules that consider several factors:
- Intended use of the device.
- The level of technical, scientific, or medical expertise required of the intended user, whether they are a lay person or a healthcare professional.
- The significance of the information provided by the device for diagnosis, taking into account the natural progression of the disease or disorder, including presenting signs and symptoms that may guide a physician.
- The potential impact of the test result, whether it is true or false, on the individual and/or public health.
IVD Medical Devices registration in Malaysia is categorized into four classes: Class A, B, C, and D. Each class is associated with a specific level of risk, and the table below provides examples of devices falling under each class.
According to the Medical Device Act 2012, any manufacturer or Local Authorized Representative representing a foreign manufacturer must register a medical device before it can be imported, exported, or made available in the Malaysian market.
Medical devices encompass a broad spectrum, ranging from simple to highly complex and sophisticated products.
In the case of general medical devices, their various components may be sold separately, as individual customized packs, or as part of a group, and they are classified into categories known as SINGLE, FAMILY, SYSTEM, and SET. Each of these categories can be included in the application for medical device registration.
Everything that is used in healthcare for the diagnosis, prevention, monitoring, or treatment of illness or disability is referred to as a “medical device,” however pharmaceuticals are not included in this definition. In-vitro diagnostics (IVDs) are covered under this definition of a medical device. Any medical device must adhere to Act 737’s Section 2.
For general medical devices, the classification of the device is based on the risk associated with it at its point of usage (the risk to patients, users, and other individuals). A device’s potential risk is determined by:
- its intended purpose
- The effectiveness of the risk-management techniques used in the design, manufacturing, and usage
- Who are its intended users, and how does it function?
For General Medical devices registration in Malaysia can be classified into 4 classes: Class A, B, C, and D. The corresponding risk level and device examples are given in the table below:
Intended use: The intended user’s technical, scientific, and medical knowledge (layperson or healthcare professional , the significance of the information to the diagnosis (single determinant or one of several), taking into account the presenting signs and symptoms that may help a doctor and the natural history of the disease or disorder;
Medical devices must first go through a conformity assessment by one of the registered Conformity Assessment Bodies (CAB) in order to submit an application for registration in Malaysia. This is a systematic review of the data gathered and actions taken by the manufacturer to confirm that a medical device complies with the MDA’s Essential Principles of Safety and Performance for Medical Devices and is both safe and performs as intended by the manufacturer.
Offer qualified guidance on how to prepare the technical documentation for medical devices
Class B, C, and D medical devices should at least have the approval of their place of origin if they haven’t already received it in one of the recognised countries. The CAB is going to conduct an extensive investigation in this instance; however it will take longer than usual because it will be more thorough.
Class B, C, and D medical devices can use MeDC@St2.0+ to submit their registration applications after they have the CAB approval certificate in hand.
The ISO 13485:2003/2016 standard outlines the specific requirements for implementing a quality management system in the production of medical devices. Its fundamental purpose is to validate an organization’s capability to consistently provide medical devices and related services that meet customer and regulatory requirements relevant to medical devices and related services. By adhering to ISO 13485:2003/2016, the standard seeks to harmonize regulatory prerequisites for quality management systems within the medical device industry.
Additionally, ISO 13485:2003/2016 promotes a more streamlined, transparent, and well-documented management approach for regulatory-mandated tasks, including post-marketing follow-up and surveillance, complaint management, process validation (installation qualification, operational qualification, and performance qualification), handling of field corrective actions or product recalls, vigilance and reporting to competent authorities, and fostering improvements in clinical experiences.
Embracing ISO 13485:2003/2016 allows organizations to enhance their efficiency in meeting regulatory obligations, while also reinforcing their commitment to delivering high-quality medical devices and services to customers.
According to the Medical Devices Act of 2012 (Act 737), all companies involved in activities related to medical devices are required to adhere to the Good Distribution Practice for Medical Devices (GDPMD). This entails the establishment, implementation, and continuous maintenance of a quality management system by businesses operating within the medical device supply chain.
Accreditation serves as confirmation of a facility’s ability to uphold the performance, safety, and quality of medical equipment under its responsibility. The standard applies to various participants, including Malaysian distributors, importers, and representatives of international manufacturers of medical products.
Companies must adhere to ISO 15189, a comprehensive set of guidelines specifically designed for medical laboratories. This certification plays a vital role in assisting medical laboratories in the development of their quality management systems and self-assessment of their competence. Moreover, ISO 15189 certification serves as a valuable tool for validating and acknowledging the proficiency of medical laboratories by regulatory authorities, laboratory customers, and accreditation bodies.
In essence, achieving ISO 15189 certification serves as a testament to a laboratory’s unwavering dedication to delivering precise and dependable results, thereby reinforcing the trust of stakeholders and reinforcing the laboratory’s commitment to excellence.
In compliance with prevailing regulations, most countries mandate foreign manufacturers of medical devices or in-vitro diagnostics (IVDs) to appoint a local authorized representative (LAR) if they opt not to establish a foreign subsidiary within the country.
This designated representative, also referred to as the in-country representative, local agent, or marketing authorization holder, serves as the principal point of contact for all regulatory matters concerning the medical device or IVD. These responsibilities encompass various aspects, including product registrations, import and distribution licenses, change notifications, as well as post-market surveillance, encompassing adverse event reporting and product recall procedures.
The LAR effectively represents and liaises on behalf of the foreign manufacturer with local medical device authorities throughout these interactions.
The appointment of a local authorized representative (LAR) does not absolve the manufacturer of their responsibilities; instead, it necessitates careful selection and close supervision by the manufacturer.
Regulatory guidelines typically lack a comprehensive outline of the LAR’s role and obligations, making it essential for both the foreign manufacturer and the in-country representative to establish a contractual agreement defining the delegated tasks and authority.
The selection of an in-country representative well-versed in the regulatory requirements of the specific country is critical to ensuring that they can effectively act in the best interests of the foreign manufacturer.
As your designated local authorized representative in Malaysia we will:
Serves as your designated point of contact with the local medical device authorities responsible for medical devices and in-vitro diagnostics, encompassing the following key responsibilities:
- Product registration
- Obtaining import licenses
- Obtaining distribution licenses
- Submitting change notifications
- Transferring product licenses
- Ensuring post-market surveillance, including adverse events and product recalls, once your product is authorized and placed in the market.
2. Ensure compliance with the appropriate conformity assessment procedure, if deemed necessary.
3. Verify accurate and compliant labeling of the medical device or IVD, with information provided in the specified national language(s).
4. Act as the primary liaison for all interactions with the local medical device authority, handling inquiries and coordinating necessary inspections of the manufacturer’s facilities, as needed.
5. Maintain a dedicated place of business within the country, equipped with functional telephone and email connections throughout the contractual term.
6. Offer support in managing product-related complaints in accordance with regulatory protocols.
7. Proactively monitor regulatory changes and updates, promptly notifying you of any pertinent revisions or new requirements impacting your product.
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