Medical Device Registration

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Kayv Consulting Services is a professional consulting firm that offers the best consulting and training service on improving and enhancing the quality systems, project development and business services of a company.

🚀 Planning to Register Your Medical Device in Malaysia?Navigating medical device regulations can be complex, but you don...
24/05/2026

🚀 Planning to Register Your Medical Device in Malaysia?

Navigating medical device regulations can be complex, but you don’t have to do it alone.

At KAYV Consulting Services, we provide professional regulatory consulting and compliance support to help manufacturers, importers, distributors, and brand owners meet Malaysian Medical Device Authority (MDA) requirements.

Our Services:
✅ Medical Device Registration (MDA)
✅ Establishment Licence (EL) Application & Renewal
✅ GDPMD Certification Support
✅ ISO 13485 Compliance & Documentation
✅ CSDT File Preparation & Review
✅ Product Classification & Regulatory Strategy
✅ Authorized Representative (AR) Support
✅ Medical Device Advertising Consultation & Compliance Review
✅ Regulatory Gap Assessment & Consultation

🌟 Trusted Regulatory Partner Since 2014
🌟 More Than 12 Years of Industry Experience
🌟 End-to-End Regulatory Support
🌟 Practical & Professional Solutions

Whether you are launching a new medical device, expanding your product portfolio, or ensuring your promotional materials comply with regulations, KAYV Consulting Services is here to support you every step of the way.

📧 [email protected]

21/10/2025

How do I register a medical device in Malaysia?

Once a company obtains MDA Establishment License, one can begin to register medical devices.

Briefly the process is as follows: classify the device, prepare the CSDT file, undergo CAB assessment (for Class B–D), and submit through MeDC@St.

After review and approval, a registration certificate is issued, valid for 5 years.

21/10/2025

After GDPMD, how to apply for MDA Establishment License?

After receiving certification for GDPMD, apply for establishment license through the MeDC@St portal by submitting company details, GDPMD/ISO certificates, and fees.

Once approved, the license allows legal operation in Malaysia's medical device market.

Beware on the scope of establishment license as only listed activities are allowed for an establishment.

21/10/2025

How to get GDPMD certified?

To get GDPMD certified, a company implements a quality management system, applies to a Certified Assessment Body (CAB), undergoes an audit, fixes any non-compliance, and receives certification if all standards are met.

21/10/2025

What is GDPMD in Malaysia?

GDPMD (Good Distribution Practice for Medical Devices) is a quality standard required by the Medical Device Authority for companies distributing, importing, or representing medical devices in Malaysia.

It ensures safe storage, handling, and traceability throughout the supply chain.

It is issued by a third party assessment body known as Certified Assessment Body (CAB).

27/10/2024

Good Distribution Practice for Medical Devices (GDPMD)

Ensure an establishment's ability to maintain the quality, safety and performance of medical devices

About the Good Distribution Practice for Medical Devices (GDPMD)
The Good Distribution Practice for Medical Devices (GDPMD) applies to all companies carrying out activities, as stated in the Medical Devices Act 2012 (Act 737). The companies involved in the supply chain of medical devices must establish, implement and maintain a quality management system.

The certification ensures an establishment’s ability to maintain the quality, safety and performance of medical devices in its custody. The standard involves parties such as representatives of foreign manufacturers, importers and distributors of medical devices in Malaysia.

Benefits of Good Distribution Practice for Medical Devices (GDPMD)
Medical devices are appropriately managed and controlled throughout the supply chain. Thus, ensuring their safety and performance at the point of use.
Assures stakeholders through certification that the organisation can maintain quality, safety and performance of medical devices while under its custody.
Fulfilment of establishment licensing requirements.

27/09/2024

What is considered a medical device in Malaysia?

The term ‘medical device’ covers any product used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability but excludes drugs. This definition of medical device includes in-vitro diagnostics (IVDs).
Any medical device must comply with Section 2 of Act 737 (refer to guidance document MDA/GD/0006) and shall register under the Act before it can be imported, exported or placed in the market.

Please note: in this webpage we will use the term medical devices to include medical devices as well as in-vitro diagnostics.

Who can register a medical device in Malaysia?Only companies registered locally in Malaysia with the Companies Commissio...
27/09/2024

Who can register a medical device in Malaysia?

Only companies registered locally in Malaysia with the Companies Commission (SSM) (government authority responsible for company registrations) may apply to obtain an establishment license, register a medical device and apply for an export permit.
Once registered with the SSM, a company needs to create just one account on [email protected]+ from where they apply initially for an Establishment License according to their activity:
Manufacturer’s License, Importer’s License, Distributor’s License or Authorized Representative’s License.
Only companies which have an Establishment License can register a medical device in Malaysia.

Medical device registration in MalaysiaMedical device registration in Malaysia is regulated by the Medical Device Author...
27/09/2024

Medical device registration in Malaysia

Medical device registration in Malaysia is regulated by the Medical Device Authority (MDA), a federal statutory agency under the Ministry of Health (MoH). The MDA implements and enforces the Medical Device Act 2012 (Act 737).
All medical devices that are imported, exported or placed on the market in Malaysia whether manufactured domestically or not, must be registered with the Medical Device Authority (MDA) before they can be supplied in Malaysia.
All applications for medical device registration must be done via the online system called Medical Device Centralized Online

Application System ([email protected]+) which is another enhancement to the online application system otherwise known as Medcast.

25/07/2024

MALAYSIA MEDICAL DEVICE CLASSIFICATION

The Malaysian Medical Device Authority (MDA) created a classification system based on Medical Device Regulation 2012 which is closely aligned with the ASEAN MDD.

The risk level is dependent on the intended use, effectiveness of risk management techniques applied during design, manufacture and use, its intended user(s), mode of operation, and technologies used.

Products are classified into one of the following, from lowest to highest risk:

Class A
Class B
Class C
Class D
Combination Devices
The following general principles from section 5 apply (page 4):

The classification of the device is based on the risk associated to it at the point of usage (The risk to patients, users, and other persons)
The risk presented by a particular device depends on:
Its intended purpose
The effectiveness of the risk management techniques applied during design, manufacturing, and use its intended user(s)
Its mode of operation technologies.
Factors from section 6 that may affect medical device classification are the following (page 5):

The duration of contact of the device with the body the degree of, and site of, invasiveness into the body, whether the device deliver medicines or energy to the patient, whether the device is intended to have a biological effect on the body intended action on the human body local versus systemic effects, whether the device comes into contact with injured skin and whether for diagnosis or treatment the ability to be re-used or not, combination of devices


IVD CLASSIFICATION RULES
IVDs are categorized separately from other medical devices and are further subdivided into one of the following, from lowest to highest risk:

Class A
Class B
Class C
Class D

Risk is determined by intended use, the expertise of the intended user, the importance of the resulting information of the diagnostic, and the impact of the test results. For example, a pregnancy test is Class B whereas an HIV Blood Test is Class D.

As the risk increases, more documentation may be required. For more details, contact KayV Consulting.

Address

1103A CASA MILA TOWER
Batu Caves
68100

Telephone

+60125011914

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