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FAQ - Malaysia (MDA) Regulations for Medical Device Registration

Here are answers to some of the Frequently Asked Questions (FAQs) about Malaysia regulations for Medical Device registration.

What is the regulatory authority responsible for medical device registration in Malaysia?

The regulatory authority responsible for medical device registration in Malaysia is the Medical Device Authority (MDA), a federal statutory agency under the Ministry of Health (MoH). The MDA implements and enforces the regulations as per Medical Device Act 2012 (Act 737).

What are the steps involved in the registration process of medical device in Malaysia as per MDA regulations?

The following are the steps involved in the registration process of medical device in Malaysia as per MDA regulations:

  1. Establishment of an Authorized Representative (AR). The AR is a legal entity that is responsible for representing the manufacturer of the medical device in Malaysia. The AR must be registered with the MDA.

  2. Classification of the medical device. The medical device must be classified according to its risk level. There are four classes of medical devices in Malaysia: Class A, Class B, Class C, and Class D.

  3. Obtaining a Conformity Assessment Body (CAB) report. The CAB is a third-party organization that assesses the conformity of the medical device to the Malaysian Medical Device Regulations. The CAB report is required for the registration of the medical device.

  4. Submission of the registration application. The registration application must be submitted to the MDA through the MeDC@St online system. The application must include the following documents:

  • A completed registration form

  • The CAB report

  • The technical documentation of the medical device

  • The declaration of conformity

  1. Payment of the registration fee. The registration fee is RM1,300 for Class A devices, RM1,300 for Class B devices, RM3,000 for Class C devices, and RM6,000 for Class D devices.

  2. Review of the application by the MDA. The MDA will review the application and issue a decision within 6 to 8 weeks for Class A devices, 3 to 6 months for Class B devices, 3 to 6 months for Class C devices, and 3 to 6 months for Class D devices.


If the application is approved, the MDA will issue a registration certificate. The registration certificate is valid for five years.

The following are the estimated timelines for the registration process:

  • Class A devices: 6 to 8 weeks

  • Class B devices: 3 to 6 months

  • Class C devices: 3 to 6 months

  • Class D devices: 3 to 6 months

Please note that these are just estimated timelines and the actual time may vary depending on the complexity of the application.


Are there any specific labeling or packaging requirements for medical devices in Malaysia as per MDA regulations?

Yes, there are specific labeling and packaging requirements for medical devices in Malaysia as per MDA regulations. These requirements are set out in the Medical Device (Labelling and Packaging) Regulations 2012.

  • The labeling of medical devices must include the following information:

  • The name and address of the manufacturer or authorized representative

  • The Malaysian medical device registration number

  • The name and model of the medical device

  • The batch or serial number

  • The date of manufacture and expiry date

  • The intended use of the medical device

  • Any warnings or precautions

  • The instructions for use

The packaging of medical devices must also meet certain requirements. The packaging must be:

  • Durable and protect the medical device from damage

  • Labeled with the same information as the label

  • Child-resistant if the medical device is a controlled substance

The MDA has also published a guidance document on the labeling and packaging of medical devices. This document provides more detailed information on the requirements.

Here are some additional labeling and packaging requirements for medical devices in Malaysia:

  • The label must be in Bahasa Malaysia and English.

  • The label must be legible and permanent.

  • The label must be prominently displayed on the medical device or its packaging.

  • The label must not contain any false or misleading information.

If you are importing or distributing medical devices in Malaysia, it is important to ensure that they meet the labeling and packaging requirements. Failure to comply with these requirements could result in the medical device being seized or prohibited from sale.


Are clinical trials or testing necessary for registration? If so, what are the requirements?

Clinical trials or testing are not generally required for registration of medical devices in Malaysia as per MDA regulations. However, there are some exceptions. For example, clinical trials may be required for Class D medical devices, or for medical devices that are intended for a new indication or use.


If clinical trials are required, the MDA will specify the requirements in the registration application. The requirements may include the following:

  • The design of the clinical trial

  • The number of subjects in the clinical trial

  • The duration of the clinical trial

  • The data that must be collected from the clinical trial

The MDA may also require that the clinical trial be conducted in Malaysia. If the clinical trial is conducted in another country, the MDA will require that the results of the clinical trial be reviewed by a local ethics committee.


If you are unsure whether clinical trials or testing are required for your medical device, you can get in touch with our team.


Here are some additional information about clinical trials and testing for medical devices in Malaysia:

  • Clinical trials must be conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice (GCP) guidelines.

  • The results of the clinical trial must be published in a peer-reviewed journal.

  • The clinical trial must be registered with a clinical trial registry.


What are the fees associated with the registration process?

The fees associated with the registration process of medical devices in Malaysia are as follows:

  • Application fee: RM100 for Class A devices, RM250 for Class B devices, RM500 for Class C devices, and RM750 for Class D devices.

  • Registration fee: RM1,300 for Class A devices, RM1,300 for Class B devices, RM3,000 for Class C devices, and RM6,000 for Class D devices.

  • CAB report fee: Varies depending on the CAB.

Please note that these fees are subject to change. The latest fees can be found on the MDA website.

In addition to the fees, there are also other costs associated with the registration process, such as the cost of technical documentation, the cost of translations, and the cost of shipping.

The total cost of registering a medical device in Malaysia will vary depending on the type of device, the complexity of the application, and the fees charged by the CAB.

Here are some additional information about the fees associated with the registration process of medical devices in Malaysia:

  • The application fee is payable when the registration application is submitted.

  • The registration fee is payable when the registration certificate is issued.

  • The CAB report fee is payable to the CAB that is conducting the conformity assessment.

The MDA may waive the application fee for Class A devices that are intended for use in public health programs.


Is it necessary to have a local authorized representative in Malaysia for Medical Device registration?

Yes, it is necessary to have a local authorized representative (AR) in Malaysia for medical devices registration. The AR is a legal entity that is responsible for representing the manufacturer of the medical device in Malaysia. The AR must be registered with the Medical Device Authority (MDA).

The AR has the following responsibilities:

  • Submitting the registration application to the MDA

  • Communicating with the MDA on behalf of the manufacturer

  • Providing the MDA with any additional information that is requested

  • Ensuring that the medical device complies with Malaysian regulations

  • Handling complaints and recalls

The AR must be located in Malaysia and must have a valid AR license issued by the MDA. The AR must also have a sound understanding of the Malaysian medical device regulations.

If you are a foreign manufacturer of medical devices, you will need to appoint an AR in Malaysia if you want to register your devices in Malaysia. You can appoint a distributor, a trading company, or a specialized AR company to be your AR.

Here are some of the benefits of having a local AR in Malaysia:

  • The AR can help you navigate the Malaysian medical device regulations

  • The AR can represent you in dealings with the MDA

  • The AR can handle complaints and recalls

  • The AR can provide you with local market information

If you are considering registering your medical devices in Malaysia, contract Artixio to discuss your options.


Are there any post-registration obligations or reporting requirements?

Yes, there are post-registration obligations or reporting requirements for medical devices in Malaysia. These requirements are set out in the Medical Device (Duties and Obligations of Establishment) Regulations 2019.

The following are the post-registration obligations or reporting requirements for medical devices in Malaysia:

  • Distribution records: The establishment must maintain records of the distribution of the medical device, including the consignee, the specifications of the device, the place of storage, details about the delivery and receipt, and details about the disposal of the device.

  • Complaint handling: The establishment must have a system for handling complaints about the medical device. The system must include a process for investigating complaints and taking corrective action.

  • Mandatory Problem Reporting (MPR): The establishment must report any incidents relating to the medical device to the MDA. These incidents include:

    • Serious adverse events

    • Death or serious deterioration in health

    • Events that could have led to death or serious deterioration in health

  • Field Corrective Action (FCA): The establishment must take corrective action to address any problems with the medical device. This may include recalling the device, modifying the device, or providing additional information to users.

  • Medical Device Recall: The establishment must recall the medical device if it is determined to be unsafe or ineffective. The recall must be conducted in accordance with the MDA's guidelines.

The establishment must comply with these post-registration obligations or reporting requirements in order to maintain the registration of the medical device in Malaysia. Failure to comply with these requirements could result in the registration of the medical device being revoked.


Are there any exemptions or expedited processes available for certain types of medical devices?

Yes, there are some exemptions or expedited processes available for certain types of medical devices in Malaysia. These exemptions are granted on a case-by-case basis and are subject to the approval of the Medical Device Authority (MDA).

Some of the exemptions or expedited processes that may be available include:

  • Exemption from clinical trials: This exemption may be granted for medical devices that are intended for a new indication or use, but that are essentially the same as a device that is already registered in Malaysia.

  • Expedited registration process: This process may be available for medical devices that are intended for a public health program or that are used in a clinical trial.

  • Exemption from the requirement for a Conformity Assessment Body (CAB) report: This exemption may be granted for medical devices that are manufactured in a country that has a Mutual Recognition Agreement (MRA) with Malaysia.

The MDA may also grant exemptions or expedited processes for other reasons, such as if the medical device is intended for use in a research study or if the medical device is a new technology that has not been previously approved in Malaysia.

If you are interested in applying for an exemption or expedited process for your medical device, you should contact the MDA for more information.

Here are some of the criteria that the MDA may consider when granting an exemption or expedited process:

  • The risk level of the medical device

  • The availability of clinical data

  • The need for the medical device in Malaysia

  • The impact of the exemption or expedited process on public health

The MDA may also require that the applicant provide additional information or documentation to support the application.

If you are granted an exemption or expedited process, you will still need to comply with the relevant Malaysian medical device regulations. This includes the requirements for labeling, packaging, and post-market surveillance.


Are there any unique considerations or requirements for software or digital health applications?

Yes, there are some unique considerations or requirements for software or digital health applications in Malaysia as per MDA regulations. These include:

  • Software as a medical device (SaMD) classification: SaMD is classified as a medical device in Malaysia. This means that SaMD must comply with the same regulations as other medical devices, such as the requirement for a Conformity Assessment Body (CAB) report.

  • Software validation: Software validation is a process of ensuring that the software is fit for its intended purpose. This is an important consideration for SaMD, as the software must be able to safely and effectively deliver the intended medical benefit.

  • Privacy and security: Privacy and security are important considerations for all software applications, but they are especially important for SaMD. This is because SaMD may collect and process sensitive personal health information.

  • Clinical evaluation: Clinical evaluation is the process of assessing the safety and effectiveness of a medical device. This is an important consideration for SaMD, as the software must be shown to be safe and effective for its intended use.

  • Labeling and packaging: The labeling and packaging of SaMD must comply with the Malaysian medical device regulations. This includes the requirement to include certain information on the label, such as the intended use, the risks associated with the use, and the instructions for use.

In addition to these considerations, there are also some specific requirements for SaMD in Malaysia. These requirements are set out in the Medical Device (Software as a Medical Device) Regulations 2019.

If you are developing a SaMD for use in Malaysia, you should carefully consider these requirements and ensure that your software complies with all applicable regulations.


Are there any local standards or additional testing requirements beyond international standards?

Yes, there are some local standards or additional testing requirements in Malaysia for medical devices beyond international standards. These include:

  • The Malaysian Medical Device (Safety and Performance) Regulations 2012: These regulations set out the specific safety and performance requirements for medical devices in Malaysia.

  • The Malaysian Medical Device (Labelling and Packaging) Regulations 2012: These regulations set out the specific labeling and packaging requirements for medical devices in Malaysia.

  • The Malaysian Medical Device (Clinical Evaluation) Regulations 2019: These regulations set out the specific clinical evaluation requirements for medical devices in Malaysia.

  • In addition to these regulations, there are also some specific standards that are recognized by the Malaysian Medical Device Authority (MDA). These standards include:

  • The International Organization for Standardization (ISO) 13485:2016: This standard specifies requirements for a quality management system for the design, development, production, installation, and servicing of medical devices.

  • The International Electrotechnical Commission (IEC) 62366:2007: This standard specifies requirements for the usability of medical devices.

The MDA may also require that medical devices comply with other standards, depending on the specific device and its intended use.


If you are importing or distributing medical devices in Malaysia, you should carefully consider these requirements and ensure that your devices comply with all applicable regulations.

Here are some of the reasons why local standards or additional testing requirements may be imposed in Malaysia:

  • To ensure that medical devices are safe and effective for use in the Malaysian population.

  • To protect the health of Malaysian patients.

  • To ensure that medical devices comply with the latest international standards.


Can I use a foreign clinical study or data for registration purposes?

Yes, you can use a foreign clinical study or data for medical devices registration purposes in Malaysia. However, there are some requirements that must be met in order to use foreign clinical data.


First, the foreign clinical study must have been conducted in accordance with the Good Clinical Practice (GCP) guidelines. The GCP guidelines are international standards for the conduct of clinical trials.


Second, the foreign clinical study must be relevant to the Malaysian population. This means that the study must have been conducted on a population that is similar to the Malaysian population in terms of age, sex, and ethnicity.


Third, the foreign clinical study must be translated into Bahasa Malaysia. This is the national language of Malaysia.


Fourth, the foreign clinical study must be submitted to the Malaysian Medical Device Authority (MDA) for review. The MDA will review the study to ensure that it meets the requirements for registration.


If the foreign clinical study meets all of the requirements, it can be used to support the registration of the medical device in Malaysia.


Here are some of the benefits of using foreign clinical data:

  • It can save time and money.

  • It can help to ensure that the medical device is safe and effective for use in the Malaysian population.

  • It can help to support the registration of the medical device in other countries.

However, there are also some risks associated with using foreign clinical data:

  • The data may not be relevant to the Malaysian population.

  • The data may not be translated into Bahasa Malaysia.

  • The data may not be approved by the MDA.

If you are considering using foreign clinical data to support the registration of your medical device in Malaysia, you should carefully consider the risks and benefits.



 

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