AUTHORIZED REPRESENTATIVE (MEDICAL DEVICES MALAY)

REGULATING MEDICAL DEVICES

To place medical devices on the market in Malaysia, non-local companies must comply with regulatory requirements established by the Medical Device Authority (MDA) and the Medical Device Act 2012 (Act 737).

COUNTRY AUTHORIZED REPRESENTATIVE RESPONSIBILITIES

Non-local companies are required to appoint a Malaysia Authorised Holder (MAH) based in Malaysia.

The authorized holder acts as a liaison between the non-local company and the MDA.

They assist with regulatory submissions and communication with Malaysian authorities.

Medical Device registration applications must be registered on the MEDCAST system by the Malaysia Authorized Holder (MAH).

Here is a summarized overview of the key compliance requirements with an emphasis on the role of the authorized representative:

1. Product Registration:

• Non-local companies must register their medical devices with the MDA before they can legally market and sell them in Malaysia.
• Registration includes submitting comprehensive documentation on the device's safety, quality, and effectiveness.

2. Authorized Representative:

3. Conformity Assessment:

• Depending on the risk classification, medical devices may need to undergo conformity assessment procedures, such as conformity assessment bodies (CABs) or self-declaration for lower-risk devices.

4. Quality Management System (QMS):

• Medical device companies must establish and maintain a QMS compliant with ISO 13485 or other relevant standards.
• The MDA may audit the QMS to ensure compliance.

5. Labeling and Packaging:

• Medical device labeling and packaging must comply with Malaysian regulations, including language requirements and specific labeling content.
• The authorized representative may assist in ensuring proper labeling and packaging.

6. Clinical Data and Testing:

• Depending on device classification, clinical data and testing may be required to demonstrate safety and efficacy.
• Non-local companies must provide this data as part of the registration process.

7. Post-Market Surveillance:

• Companies must establish a system for monitoring and reporting adverse events or product defects to the MDA.
• The authorized representative may help with reporting obligations.

8. Fees and Payments:

• Non-local companies are typically required to pay registration fees and annual renewal fees.
• The authorized representative can assist in handling these financial transactions.

9. Compliance with Malaysian Laws:

• Non-local companies must adhere to all Malaysian laws and regulations concerning medical devices.
• The authorized representative plays a role in ensuring ongoing compliance.

10. Notification of Changes:

• Any changes to the medical device or its manufacturing process must be reported to the MDA through the authorized representative.

11. Periodic Inspections:

• The MDA may conduct periodic inspections of the manufacturing facilities, storage facilities, and records of non-local companies through the authorized representative.

In summary, non-local companies seeking to place medical devices on the market in Malaysia must comply with a range of regulatory requirements. The authorized representative, if required, plays a crucial role in facilitating compliance, regulatory submissions, and communication with Malaysian authorities.

Effective collaboration with the authorized representative is essential for successfully navigating the regulatory landscape in Malaysia.