Medical Device Registration Information

Introduction: In accordance with Section 5 (1) of the Medical Device Act 2012 (Act 737), no medical device shall be imported, exported or placed in the market unless the medical device is registered under this Act.

Definition of Medical Device: Medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of:-

• diagnosis, prevention, monitoring, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
• investigation, replacement or modification, or support of the anatomy or of a physiological process;
• support or sustaining life;
• control of conception;
• disinfection of medical device; or
• providing information for medical or diagnostic purpose by means of in vitro examination of specimens derived from the human body, which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means.

1. Related Legislation and Circular Letter   

2. Related Guideline and Guidance Document 

3. Overview of Medical Device Registration Framework 

4. Registration Process Flow for Class A Medical Device

• Class A (New & Re-Registration Application) Requirements via [email protected]+
• Registration Process Flow for Class B, C and D Medical Device
•  Class B, C or D (New & Re-Registration Application) Requirements via [email protected]+

5. How to Create a MeDC@St Account

• User manual - Class A medical device application 
• User manual – Class B, C and D medical device application
• 

6. Rules of Classification

• Rules of Classification for General Medical Device
• Rules of Classification for In Vitro Diagnostic Medical Device

7. Grouping

• Grouping for General Medical Device 
• Grouping for In Vitro Diagnostic Medical Device

8. Conformity Assessment for Medical Device

9. Recognised foreign regulatory authorities and notified bodies and the respective approval types eligible for conformity assessment by way of verification process

10.  Information on Fee Structure for Medical Device Registration

11. New information and announcement:

• ANNOUNCEMENT UPDATE: MDA APPROACH FOR NEW REGISTRATION OF MEDICAL DEVICES WITH EXPIRED EC CERTIFICATES  
•  SUBMISSION OF MEDICAL DEVICE RE-REGISTRATION APPLICATIONS   
• Enhanced Process for Managing Classification Risk Disputes Between Establishment and CAB 

•  Classification and Registration Technical Committee Meeting : 2025 Meeting Schedule Planner

• MDA Approach for New and Re-Registration of Medical Devices With Expired EC Certificates and Self-Declared Class B IVD  - refer to the updated announcement.
• Engagement with IVD Establishments & Survey on In-Vitro Diagnostic Issues 

  - Latest Updates on IVD Registration Requirements

  - Compilation of Questions & Answers related on IVD issues

• [email protected] Project Development Update - License & Registration Modules
•  Establishments are Advised to Submit Medical Device Re-Registration Applications in the [email protected]+ System One year Prior to Certificate Expiration Date.
• Medical Device Re-Registration Application: Implementation of Initial MDA Response Within 14 Working Days
• Statistic Year 2024 
• 2024 Meeting Decision :

•  Pelaksanaan Penggunaan Sijil Pendaftaran Peranti Perubatan Elektronik Sepenuhnya Bermula 1 November 2023
• MDA Approach on Expired EC Certificate for New Registration and Re-registration of Medical Device - refer to the updated announcement. 
• Withdrawal of Medical Device Registration (New and Re-Registration) And Change of Notification Application
•  Statistic Year 2023
• 2023 Meeting Decision : 

• How to check whether a device is registered or not
• 
  

13. Frequently Ask Questions (FAQs) – under revision

14. For any inquiries, kindly contact us for further assistance:

a. Registration Unit email address:

• General email:  [email protected]
• IVD email:  [email protected]
• Officers’ email and contact number: BKPP Staff Directory