In Malaysia, the Class A medical device is defined as a device that poses the lowest risk to patients and users. These devices typically have minimal invasive properties, are non-sterile, and are not intended to be used in life-threatening situations. Examples of Class A devices may include items like bandages, thermometers, or non-invasive stethoscopes.

The Medical Device Authority (MDA), which operates under the Ministry of Health, regulates the registration and monitoring of medical devices in Malaysia to ensure their safety and effectiveness.

Steps to apply for Class A Medical Device Registration in Malaysia:

1. Establish a Local Authorized Representative:

   • If the manufacturer is based outside Malaysia, they need to appoint a local authorized representative (LAR) in Malaysia who will handle the regulatory processes.

2. Prepare the Necessary Documents:

   • Certificate of Free Sale from the country of origin, indicating that the device is legally marketed there.
   • Labeling and Instructions for Use that meet MDA’s standards.
   • Risk Classification documentation that confirms the device qualifies as Class A.
   • Declaration of Conformity to show the device complies with Malaysian regulations and standards.

3. Online Registration:

   • Go to the MDA's Medical Device Centralized Application System (MDCAS) or MDA e-RIS portal.
   • Create an account for your company if you don’t already have one.
   • Submit the required documents and product information via the system.

4. Pay the Registration Fee:

   • A non-refundable fee is applicable for the registration of Class A medical devices. The fee structure is available on the MDA website.

5. Evaluation and Approval:

   • Once the application is submitted, MDA will review the documents. For Class A devices, the process is typically faster than for higher-risk categories, but it may still take a few weeks.

6. Obtain Registration Certificate:

   • After successful evaluation, MDA will issue a Medical Device Registration Certificate for the Class A device, authorizing it for sale in Malaysia.

Important Notes:

• MDA Inspection: Though Class A devices generally do not require an audit or inspection before approval, MDA may still perform inspections to ensure compliance.
• Post-Market Surveillance: After registration, manufacturers and authorized representatives are expected to monitor the device's safety and effectiveness in the market.

It is crucial to ensure that all regulatory requirements are met to prevent any delays or rejections in the registration process.

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