In Malaysia, the classification of medical devices is defined by the Medical Device Authority (MDA) under the Medical Device Act 2012 (Act 737) and the associated regulations. D-class medical devices represent the highest risk category within this classification system.

What is a D-Class Medical Device?

D-class (High-Risk) Medical Devices:

• High Risk: These devices are considered to present the highest risk to patients and users due to their intended use, potential risks, or the complexity of their operation. They often include life-supporting or life-sustaining devices, high-risk implantable devices, or devices that are critical to maintaining patient health.
• Examples: Examples of D-class devices might include heart pacemakers, deep brain stimulators, and some high-risk surgical implants.

Registration Process

The registration process for D-class medical devices in Malaysia involves several key steps, due to the high-risk nature of these devices. Here’s an overview:

1. Compliance with Regulations: Manufacturers must comply with the Medical Device Act 2012 and Medical Device Regulations 2012. This involves adhering to stringent safety, effectiveness, and quality standards.

2. Quality Management System (QMS): Manufacturers need to implement and maintain a QMS compliant with ISO 13485. This certification demonstrates adherence to international standards for medical device manufacturing.

3. Technical Documentation: Detailed technical documentation must be prepared, including device specifications, risk management reports, clinical evaluations, and performance testing results.

4. Conformity Assessment: A Conformity Assessment Body (CAB), accredited by the MDA, must review and assess the device's conformity to Malaysian regulations. This includes reviewing the technical documentation and performing necessary audits.

5. Submission of Application: The application for registration must be submitted through the MeDC@St online system. This includes providing all required documents and paying the applicable fees.

6. MDA Review: The MDA reviews the submitted application, technical documentation, and the CAB’s assessment report. Additional information may be requested if needed.

7. Issuance of Certificate: Upon successful review, the MDA issues a Certificate of Registration, allowing the device to be marketed and sold in Malaysia.

8. Post-Market Requirements: Manufacturers must implement Post-Market Surveillance (PMS) to monitor the device's performance, manage adverse events, and take corrective actions if necessary. Regular renewal of registration and updates may also be required.

Significance of Registration

• Regulatory Compliance: Registration ensures that the medical device complies with Malaysian safety and efficacy standards.
• Market Access: It authorizes the manufacturer to market and distribute the device in Malaysia.
• Consumer Safety: It provides assurance to healthcare professionals and patients about the safety and effectiveness of high-risk devices.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn