MEDICAL DEVICE REGISTRATION BRANCH
BRIEF INTRODUCTION AND FUNCTIONS

The Registration Branch consists of two (2) units, namely:
i. General and IVD Registration Unit
ii. Product Classification and Combination Products Unit

 

i) GENERAL AND IVD REGISTRATION UNIT
The Medical Device Registration Unit is responsible for implementing the control measures as stipulated under the Medical Device Act 2012 (Act 737). This unit processes applications and approvals for new medical device registrations and re-registrations, as well as notifications of changes to registered device information (Change Notifications).

ii) PRODUCT CLASSIFICATION AND COMBINATION PRODUCTS UNIT
BRIEF INTRODUCTION

The Product Classification and Combination Products Unit carries out the following functions:
i. To review, verify, and determine whether a product is categorized as a medical device or a non-medical device. This verification is conducted through a Product Classification application submitted together with the relevant supporting documents for the product.
ii. To evaluate applications for the issuance of an Endorsement Letter (EL) for supporting components of drug–medical device combination products.

LICENSING BRANCH
ESTABLISHMENT LICENSING UNIT


BRIEF INTRODUCTION AND FUNCTIONS

The Licensing Branch consists of three (3) units, namely:
i. Licensing Unit
ii. Conformity Assessment Body (CAB) Unit
iii. Advertisement Control and Exemption Notification Unit

i) LICENSING UNIT 

The Establishment Licensing Unit is responsible for implementing the control measures as stipulated under the Medical Device Act 2012 (Act 737). This unit processes applications and approvals for the following matters:
i. Establishment licence applications
ii. Renewal of establishment licences
iii. Amendments to establishment licences (major/minor)
iv. Change of Ownership applications
v. Withdrawal of applications
vi. Surrender of licences

ii) CONFORMITY ASSESSMENT BODY REGISTRATION UNIT (CABRU)


BRIEF INTRODUCTION

The Conformity Assessment Body Registration Unit (CABRU) is responsible for managing the registration process of Conformity Assessment Bodies (CABs), technical personnel, and registration scopes under the Medical Device Act 2012 (Act 737) and the Medical Device Regulations 2012 (MDR 2012).


The activities of this unit include application evaluation, compliance inspections, and the organisation of competency training programmes to ensure that CABs operate transparently and remain free from any conflict of interest.

iii) ADVERTISEMENT CONTROL AND EXEMPTION NOTIFICATION UNIT


BRIEF INTRODUCTION

This unit carries out the following functions and responsibilities:

i. To evaluate notification applications in accordance with the requirements under the Medical Device (Exemption) Order 2024. Several categories of exempted devices include:

a) Special Access Medical Devices, which are used by medical practitioners in emergencies or when conventional treatment is deemed unsuitable.

b) Custom-Made Medical Devices, which are specifically designed and manufactured according to a written prescription by a medical practitioner for the exclusive use of a particular patient.

c) Medical Devices for Clinical Investigation and Performance Evaluation, which are used for the purpose of conducting clinical research or evaluating device performance.

ADVERTISEMENT CONTROL UNIT
BRIEF INTRODUCTION
INTRODUCTION

The Advertisement Control Unit, under the Licensing and Conformity Assessment Body (CAB) Registration Branch, has the primary responsibility of ensuring that all advertisements for medical devices comply with the Authority's laws and regulations. This unit plays a crucial role in protecting consumer interests and ensuring that information conveyed to the public regarding medical devices is clear, accurate, and legitimate.

FUNCTIONS OF THE ADVERTISEMENT CONTROL UNIT

The unit is responsible for receiving, evaluating, reviewing, and approving advertisement applications involving registered medical devices before they are published or displayed to the public. This process ensures compliance with the legal requirements stipulated under Section 44 of the Medical Device Act 2012 (Act 737), the Medical Device (Advertising) Regulations 2019, as well as the Code of Advertisement and the Advertisement Guideline issued by the Authority.

During the evaluation process, the information submitted by applicants is carefully examined to prevent any misuse or misleading claims that may confuse consumers, and to ensure that all published advertisements are valid, accurate, and not misleading.

Prepared by: Pre-Market Control Division 

Uploaded by: Corporate Communication Division

Date of upload: 13/11/2025