To apply for the registration of a Class A medical device with the Medical Device Authority (MDA) in Malaysia, the following conditions must be met:

1. Device Classification

• The device must be classified as Class A according to MDA's classification system. Class A devices are generally considered low-risk, non-invasive medical devices that are not intended to be sterile or for long-term use.
  • Examples of Class A devices include bandages, thermometers, or non-sterile gloves.

2. Manufacturer or Authorized Representative

• Local Manufacturers: If you are the manufacturer based in Malaysia, you can apply directly for the registration.
• Foreign Manufacturers: If the device is manufactured outside Malaysia, you must appoint a Local Authorized Representative (LAR) who is based in Malaysia to handle the registration process. The LAR will be responsible for liaising with MDA on behalf of the manufacturer.

3. Compliance with MDA's Regulatory Requirements

• The manufacturer (or LAR) must ensure that the medical device complies with the Medical Device Act 2012 and the Medical Device Regulations 2012 in Malaysia.
  • The device should meet the safety and performance requirements outlined by MDA.
  • The device should also conform to international standards such as ISO 13485 (Quality Management Systems for Medical Devices) and, where applicable, ISO 14971 (Risk Management for Medical Devices).

4. Certification and Documentation

• Certificate of Free Sale (CFS): If the manufacturer is located outside Malaysia, they must provide a valid CFS issued by the relevant authority in the country of origin, which confirms that the device is freely sold in that country.
• Declaration of Conformity: The manufacturer must provide a Declaration of Conformity stating that the device complies with the applicable safety and performance standards.
• Good Manufacturing Practice (GMP) or ISO Certification: If the manufacturer is foreign, they must show evidence of compliance with GMP or have an ISO 13485 certification for medical device manufacturing.

5. Labeling Requirements

• The device must have appropriate labeling that meets MDA requirements. This includes the device name, intended use, manufacturer details, and, if applicable, instructions for use (IFU) in Bahasa Malaysia and/or English. The label must also contain safety information, such as warnings and contraindications.
• The labeling must comply with international standards (e.g., ISO 15223-1 for symbols) and MDA’s specific requirements for medical devices sold in Malaysia.

6. Risk Management and Classification

• The manufacturer or authorized representative must ensure that the device is correctly classified as Class A based on its risk profile. Class A devices are low-risk and typically non-invasive, but proper documentation must be submitted to demonstrate that the device meets the criteria.
• A risk assessment may be required, although it is typically less detailed for Class A devices compared to higher-risk devices.

7. Registration Fees

• The manufacturer or LAR must be prepared to pay the registration fee via the MDCAS portal. The fees vary depending on the type of device and whether the manufacturer is local or foreign. For Class A devices, the registration fees typically range from RM 500 to RM 1,000 for local manufacturers and RM 1,000 to RM 1,500 for foreign manufacturers.
  • The fee is non-refundable, so all information must be accurate and complete before submission.

8. Post-Market Surveillance and Adverse Event Reporting

• Once the device is registered, the manufacturer (or LAR) must comply with the post-market surveillance requirements to monitor the safety and performance of the device in the Malaysian market.
• Adverse events and device-related incidents must be reported to MDA as part of the post-market monitoring process.

9. Documentation for Local Authorized Representative (for Foreign Manufacturers)

• Appointment Letter: If the manufacturer is based outside Malaysia, the Local Authorized Representative must submit an appointment letter from the manufacturer, granting them the authority to submit the application and handle all communications with MDA on their behalf.
• The LAR must be a registered entity with the MDA, and their contact details must be provided in the registration application.

10. Regulatory Compliance with International Standards

• In addition to MDA's local requirements, the medical device must meet international standards, including:
  • ISO 13485 (Quality Management System).
  • Relevant IEC standards (e.g., IEC 60601 for electrical medical devices).
  • ISO 14971 (Risk management for medical devices).

Summary of Conditions for Class A Registration:

1. The device must be Class A, low-risk, and non-invasive.
2. If the manufacturer is foreign, appoint a Local Authorized Representative (LAR).
3. The device must comply with the Medical Device Act 2012 and Regulations 2012.
4. Submit a Certificate of Free Sale (CFS), Declaration of Conformity, and GMP/ISO certification if applicable.
5. Ensure appropriate labeling and instructions for use.
6. Pay the registration fee.
7. Comply with post-market surveillance and adverse event reporting requirements.
8. For foreign manufacturers, submit an appointment letter for the LAR.

By meeting these conditions, you can apply for the registration of a Class A medical device with MDA in Malaysia. Ensure that all documentation is accurate and complete to facilitate a smooth approval process.

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