The costs and timelines for registering a Class A medical device in Malaysia vary depending on several factors, such as the complexity of the submission, the Medical Device Authority’s (MDA) review process, and additional services like consultancy or testing. Below is an overview of the costs and timelines involved in the process.

1. Costs for Class A Medical Device Registration

A. Establishment License Fees

Before registering a medical device, the Establishment License must be obtained by the manufacturer or Local Authorized Representative (LAR). This fee covers the licensing of entities that manufacture, distribute, or import medical devices.

• Application fee for Establishment License:
  • Approximately RM 1,000 - RM 1,500 (Malaysian Ringgit), depending on the nature of the business (e.g., importer, distributor, or manufacturer).
• Renewal fees:
  • The Establishment License is usually valid for 1 to 3 years, and renewal costs are similar to the initial application fees.

B. Medical Device Registration Fees

The registration fees for a Class A medical device are relatively low compared to higher-risk classes (B, C, and D). The fees vary based on the device’s risk category.

• Registration fee for Class A medical device:
  • Approximately RM 500 - RM 1,000 per device.
  • There may be additional administrative or processing fees associated with the submission.

C. Consultancy Fees (if applicable)

If you engage a regulatory consultant to help with the application process (e.g., preparation of documents, submission), additional consultancy fees may apply.

• Consultancy fees:
  • Range from RM 5,000 to RM 10,000, depending on the complexity and scope of work.

D. Other Costs

Other potential costs include:

• ISO 13485 certification costs (if applicable): These vary based on the certifying body and are usually required for the establishment's Quality Management System.
• Testing and validation costs: If any testing (e.g., sterility, biocompatibility) is required, it will add to the overall costs.

2. Timelines for Class A Medical Device Registration

The total timeline for the Class A medical device registration process depends on several factors, including the completeness of the application, the workload of the MDA, and whether additional clarifications or documentation are needed.

A. Establishment License Timeline

• The process of applying for and receiving an Establishment License typically takes 4 to 6 weeks, assuming all required documents are submitted correctly. Delays may occur if additional information or corrections are requested.

B. Device Registration Timeline

For Class A devices, the review process is relatively faster due to the low-risk nature of the devices.

• Application review: The timeline for device registration is typically 2 to 3 months, provided all documentation is in order.
• Submission to approval: The total process, from submission to receiving the Certificate of Registration, generally takes around 3 to 6 months for Class A devices, depending on:
  • The quality and completeness of the submitted documentation.
  • MDA’s review workload.
  • Whether the MDA requests further information or clarification.

C. Post-Market Obligations

Once the device is registered, the certificate is valid for 5 years. The manufacturer or LAR is required to engage in post-market surveillance to monitor the device's performance and report any adverse events to the MDA during this period.