The cost and time required to obtain Class D medical device registration with the Medical Device Authority (MDA) in Malaysia can vary based on several factors, including the specific device, the completeness of the application, and whether any additional information is required during the review process. Here are some general guidelines:

Cost:

1. Registration Fees: The registration fees for Class D devices can range from a few thousand Malaysian Ringgit (MYR) to higher amounts, depending on the complexity of the device and the type of application. As of the last updates, fees typically fall within the range of MYR 3,000 to MYR 10,000 or more.

2. Additional Costs: Other costs may include:

   • Consulting fees (if you engage regulatory consultants for assistance)
   • Costs associated with clinical studies (if required)
   • Document preparation and translation fees (if applicable)

Timeframe:

1. Application Processing Time: The processing time for Class D medical device registration usually ranges from 6 to 12 months. This period can vary based on:

   • The completeness of the submitted documentation
   • The complexity of the device
   • Any additional information or clarification requested by the MDA during the review process

2. Pre-Submission Preparation: It's essential to factor in additional time for preparing the necessary documentation and conducting any required clinical evaluations before submission, which can take several months depending on the device.

Summary:

• Estimated Cost: MYR 3,000 to MYR 10,000 or more (varying by device complexity).
• Estimated Time: 6 to 12 months for processing, with additional time for document preparation.

For the most accurate and up-to-date information, it’s advisable to consult the MDA’s official website or contact them directly.