To apply for Class A medical device MDA registration in Malaysia, you must follow the procedure outlined by the Medical Device Authority (MDA) under the Medical Device Act 2012. Below is a step-by-step guide on how to apply:

1. Create an Account on the Medical Device Registration System (MDRS)

• Visit the MDRS Portal: Go to the official MDA Medical Device Registration System (MDRS) website.
• Create an Account: If you do not already have an account, you need to create one. Both local and foreign manufacturers can register an account. You will need to provide company details, including a valid email address and password.
• Login: Once your account is created, you can log in to the system and start the registration process.

2. Designate an Authorized Representative (for Foreign Manufacturers)

• If you are a foreign manufacturer, you are required to designate a local Authorized Representative (AR) in Malaysia. This person or entity will be responsible for handling the registration process and ensuring compliance with the regulatory requirements.
• Register the Authorized Representative: Ensure that the AR is registered in the MDRS and is linked to the registration of your device.

3. Prepare the Required Documentation

To apply for registration, you will need to gather and prepare several documents related to the device. These typically include:

• Device Description: A detailed description of the device, including its intended use, technical characteristics, and classification.
• Risk Management File: Document outlining the risk assessment of the device according to ISO 14971 (Risk Management for Medical Devices).
• Quality Management System (QMS): If applicable, evidence of ISO 13485 certification for the manufacturer, demonstrating that the device is manufactured under a quality management system.
• Labeling and Instructions for Use (IFU): Ensure that the labeling complies with MDA requirements, including proper instructions for use, warnings, and other regulatory information.
• Declaration of Conformity: A statement from the manufacturer confirming that the device complies with the relevant regulations.
• Test Reports: Performance and safety testing reports (if applicable), demonstrating that the device meets relevant safety standards.
• Certificate of Free Sale (if applicable): If the device is already sold in other markets, provide a certificate of free sale, showing it is authorized for sale in another country.
• Other Documents: Any additional documents required by the MDA based on the device type.

4. Complete the Registration Form

• Device Registration Form: Log in to your MDRS account and complete the Class A medical device registration form. You will need to provide detailed information about the device, such as:
  • Manufacturer’s name and address
  • Intended use and classification of the device
  • Device description and risk classification
  • Importer/Authorized Representative details (if applicable)

5. Pay the Registration Fee

• Registration Fee: Pay the applicable registration fee. The fees for Class A devices are generally lower compared to higher-risk devices, but the exact amount can be confirmed on the MDRS portal.
  • Payment is usually made online through the MDA’s portal using a credit card or bank transfer.

6. Submit the Application

• Once all documents are uploaded and the form is completed, submit your application through the MDRS.
• After submission, the MDA will review the documents for completeness and compliance.

7. MDA Evaluation and Review

The MDA will evaluate your application to ensure that the device complies with Malaysian regulations. The review process includes:

• Verifying the completeness of the documentation.
• Ensuring the device complies with safety, performance, and quality standards.
• Checking the risk management documentation and labeling.
• If necessary, the MDA may request additional information or clarification.

8. Issuance of Registration Certificate

• Once the MDA is satisfied with the application, they will issue a Medical Device Registration Certificate, which allows you to market and distribute the device in Malaysia.
  • The registration certificate is typically valid for 5 years from the date of issuance.

9. Post-Registration Compliance

After obtaining the registration, you are required to:

• Maintain Post-Market Surveillance: Monitor the device’s safety and performance in the market and report any adverse events to the MDA.
• Renew the Registration: At the end of the 5-year validity period, you must renew the registration to continue marketing the device in Malaysia.

Summary of Steps to Apply:

1. Create an account on the MDRS portal.
2. Designate an Authorized Representative (if applicable).
3. Prepare required documentation (technical file, labeling, quality system certificates).
4. Complete the online registration form.
5. Pay the registration fee.
6. Submit the application for MDA review.
7. MDA review and approval (typically takes 8 to 12 weeks).
8. Receive the Registration Certificate.
9. Maintain post-registration obligations.

By following these steps, you can successfully apply for and obtain Class A medical device registration with the MDA in Malaysia.

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