Are you planning to expand your business into Malaysia?
Are the numerous regulatory requirements leaving you confused?
Which products must undergo CAB certification? Is the certification process long and complicated?

This article provides a clear overview of Conformity Assessment Bodies (CABs) in Malaysia and their role in the medical device regulatory framework.

What is a CAB?

Within Malaysia’s medical device regulatory framework administered by the Medical Device Authority (MDA), a Conformity Assessment Body (CAB) serves as a critical bridge between manufacturers and market access.

A CAB is an independent third-party organization registered and recognized by the Medical Device Authority (MDA) under the Medical Device Act 2012 (Act 737). These organizations play the role of technical gatekeepers, ensuring that medical devices meet required safety, performance, and quality standards before entering the Malaysian market.

CABs conduct conformity assessments to verify that medical devices comply with applicable standards, regulatory requirements, and technical specifications. Their assessments may cover multiple areas, including:

• Product safety
• Device performance
• Quality management systems

The ultimate objective is to ensure that medical devices placed on the market are safe and perform as intended by the manufacturer, in accordance with the Essential Principles of Safety and Performance for medical devices.

Which Products Require Conformity Assessment?

According to the Medical Device Act 2012 and its associated regulations, the requirements vary by device classification.

Class A Devices

Class A devices generally do not require CAB assessment. Manufacturers may submit their registration application directly to the MDA through the MeDC@St 2.0+ system.

Class B, C, and D Devices

For Class B, C, and D devices, conformity assessment by a CAB is mandatory prior to registration.

If the device has already obtained approval from recognized regulatory authorities (such as US FDA, EU Notified Bodies, Japan, Thailand, Singapore, Australia, or the UK), CABs may adopt a Verification route, which simplifies the assessment process.

If no such approval exists, the device must undergo a full conformity assessment.

Recognized Regulatory Authorities

Malaysia recognizes approvals issued by several major international regulatory authorities or notified bodies, including:

European Union / EU Notified Bodies

Certificates issued under the following regulations may be accepted:

• Directive 93/42/EEC (MDD) Annex II Section 3 or Annex V (Class IIa devices)
• Regulation (EU) 2017/745 (MDR) Annex IX Chapters I & III or Annex XI Part A
• Directive 98/79/EC (IVDD) Annex IV or Annex V & VII (IVD devices)
• Regulation (EU) 2017/746 (IVDR) Annex IX Chapters I & III

Japan – MHLW

• Pre-market certification (Ninsho)
• Pre-market approval (Shonin)

Australia – TGA

• ARTG registration certificate

Canada – Health Canada

• Medical device license

United States – FDA

• 510(k) clearance
• Premarket Approval (PMA)

United Kingdom – MHRA

• UK Conformity Assessed (UKCA) marking

Singapore – Health Sciences Authority (HSA)

• Registration in the Singapore Medical Device Register (SMDR)

Thailand – Thai FDA

• Notification Medical Device Certificate (Class II–III)
• Medical Device License (Class IV)

Conformity Assessment Routes

There are three primary assessment pathways.

1. Full Conformity Assessment

Applicable when the device has not received approval from any recognized regulatory authority or notified body.

The CAB conducts a comprehensive review covering the device’s technical documentation, quality system, and regulatory compliance.

2. Verification Route – Initial Certification

Applicable when:

• The device has been approved by at least one recognized regulatory authority, and
• The design and intended use are identical to the approved device.

Additional requirements include:

• No reported deaths associated with the device
• No cases of serious deterioration in health
• No open safety corrective actions (including recalls)
• All incident reports and CAPA actions have been closed
• The device has not been rejected or withdrawn by any recognized authority

3. Verification Route – Re-Certification

Applicable when:

• The device has already undergone a conformity assessment and has been registered with the MDA
• The registration certificate remains valid
• No changes have been made to the design, specifications, characteristics, or registration information unless notified to MDA
• The registration has not been rejected or revoked by the MDA

If approval from a recognized regulatory authority becomes invalid or withdrawn, the device must undergo full conformity assessment.

Situations Where the Verification Route Is Not Applicable

The verification route cannot be used if the device was approved under special access or emergency authorization schemes, such as:

These programs allow temporary access to unapproved devices, typically in emergency or compassionate situations.

Conformity Assessment Process

The conformity assessment process typically includes the following stages:

1. Establishing engagement with the CAB
2. Application submission
3. Contract review
4. Pre-assessment document preparation
5. Technical documentation submission
6. Document review and evaluation
7. Certification decision
8. Notification of certification results
9. Certificate issuance after fee payment

Assessment Timeline

The typical turnaround time (TAT) for CAB conformity assessment is summarized below.
(Response preparation time from the applicant is not included.)

Estimated total timeline: approximately 1.5 months.

If you have further questions regarding medical device registration in Malaysia, feel free to contact GRZAN for professional regulatory consulting and registration support.