Simplifying Medical Device Compliance
Nuotech Medical offers expert guidance to help medical device manufacturers and distributors meet regulatory standards. We streamline the compliance process, so you can focus on innovation while we handle the complexities of regulatory requirements.
About Us
At Nuotech Medical, we are committed to simplifying the regulatory landscape for medical device manufacturers and distributors. Navigating Malaysia's complex regulatory framework can be challenging, but with our expert guidance, you can focus on innovation while we take care of compliance.
Who We Are
Nuotech Medical, is a leading consultancy specializing in regulatory affairs for medical devices in Malaysia. With a team of experienced professionals, we provide personalized support to ensure that your medical devices meet all required standards and regulations. Our deep understanding of the Medical Device Authority (MDA) requirements and international regulatory standards makes us a trusted partner in bringing medical devices to market efficiently and compliantly.
Why Choose Us
Expertise
Our in-depth knowledge of Malaysian and global medical device regulations ensures that your product meets all necessary requirements.
Efficiency
We streamline the regulatory process, helping you save time and resources.
Tailored Solutions
We offer customized solutions that align with your business needs, no matter the size or complexity of your product portfolio.
Malaysia Medical Device Regulation
Malaysia's medical device market is primarily composed of imports, in particular high-end products. All medical devices are expected to be registered. The registration process could be complicated or extended to as long as a few years. The regulatory consultants at Nuotech Medical can work with you to register your medical devices as efficiently as possible and obtain approval under Malaysia's new regulatory system. We will ensure that your products are compliant with the Malaysian device regulations
The Malaysian Medical Device Authority (MDA) is in charge of enforcing medical device regulations and medical device registration.
Yes, medical devices do require registration before they can be sold in Malaysia. Starting on July 1, 2016, Malaysia’s Medical Device Act has made it mandatory for all foreign manufacturers to register their medical device with the MDA. Additionally, all foreign manufacturers must now obtain Conformity Assessment Body (CAB) certification in order to receive MDA approval for their product registration application.
- Class A: Minimal risk (blood pressure cuffs, scissors, etc.)
- Class B: Low to moderate risk
- Class C: Moderate to high risk (moderate to high risk)
- Class D: Highest risk (implantable devices/devices that significantly affect the physiology of the human body)
To register a medical device product in Malaysia, first, the applicant should confirm a classification of the product based on the Medical Device Authority (MDA) classification. They are classified into 4 classes: A, B, C, and D in Malaysia. The registration routes vary based on the classification of the device.
For Class A devices (low-risk devices), the applicant submits the application directly to MDA. The MDA review process takes about 2-3 months. The MDA fee is about $25 (USD) per application.
For Class B devices or above (higher-risk devices), the application needs to submit an application to a local, accredited conformity assessment body (CAB), before proceeding with the submission to MDA. The CAB conducts technical assessment, which is a prerequisite for successful registration with MDA. The CAB assessment would take about 3-4 months to complete. The CAB fee is about $300 (USD) per application.
Then, the applicant will proceed with the MDA submission (attaching the CAB assessment report to the application). The MDA review process takes about 3-6 months, after the CAB stage. The MDA fee is about $270 – $1,200 (USD) per application, depending on the classification of the product.
In June 2022, the MDA released the inaugural version of the guideline outlining the re-registration procedure for registered medical devices. The process consists of two stages. In Stage 1, the applicant submits the conformity assessment application, which is evaluated by the conformity assessment body (CAB). Following this, in Stage 2, the applicant proceeds with the re-registration application through the MeDC@St application system.
Each medical device is initially registered for a period of 5 years and must undergo re-registration before it can be reintroduced to the market.
The guideline encompasses all medical device classes, with varying application and registration fees for each class.
The medical device registration form requires the following components:
- General information on the medical device
- Information on manufacturer of medical device
- Grouping of medical device
- Common Submission Dossier Template (CSDT)
- Post-market vigilance history
- Declaration of conformity
- Attestation for medical device registration
No, local testing is not required for medical device registration in Malaysia.
No, local clinical studies are generally not required for registration in Malaysia.
No, Malaysia does not currently require approval in the Country of Origin for the registration of medical devices.
Our Services
We offer a comprehensive range of services tailored to meet your regulatory needs
Medical Device Registration
We assist in the registration process with the Malaysian Medical Device Authority (MDA) to ensure your product is approved for distribution in Malaysia.
Regulatory Strategy Consultation
We provide customized strategies to help you navigate regulatory hurdles and ensure compliance with local and international standards.
Product Classification
Determining the appropriate classification for your medical device is crucial. We assist in accurately classifying your product according to Malaysian regulations.
Good Distribution Practice for Medical Devices (GDPMD) Implementation
We help you establish and maintain a QMS that complies with GDPMD and other relevant standards, ensuring your product's quality and safety.
