In Malaysia, an annual review is not explicitly required for Class B medical device registration; however, manufacturers are obligated to maintain ongoing compliance with regulatory standards and to conduct regular evaluations of their devices. Here are some key points to consider:

1. Post-Market Surveillance:

• While there is no formal annual review process, manufacturers are required to implement a post-market surveillance system to monitor the safety and performance of their devices once they are on the market. This involves collecting and analyzing data on adverse events, complaints, and user feedback.

2. Quality Management System (QMS):

• Manufacturers must maintain their quality management system (e.g., ISO 13485) and ensure it is regularly reviewed and updated. This may involve conducting internal audits and management reviews, which could occur annually or at other intervals as determined by the organization.

3. Reporting Obligations:

• If there are any changes to the device, its intended use, or the manufacturing process, the manufacturer must notify the Medical Device Authority (MDA) and may need to submit a new application or variation for the registration.

4. Renewal of Registration:

• Class B medical device registrations are typically valid for five years, and manufacturers must submit a renewal application before the expiration date. The renewal process involves a review of post-market data and compliance with updated regulations.

5. Stay Informed:

• Manufacturers should keep abreast of any updates or changes in regulations or guidelines from the MDA, as these may impact their obligations regarding device management and oversight.

In summary, while an annual review is not a formal requirement for Class B medical device registration, ongoing compliance, post-market surveillance, and regular quality system evaluations are essential to ensure the safety and efficacy of the device.