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:-

  1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
  2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
  3. investigation, replacement or modification, or support of the anatomy or of a physiological process;
  4. support or sustaining life;
  5. control of conception;
  6. disinfection of medical device; or
  7. 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.

5. Rules of Classification

    1. Rules of Classification for General Medical Device
    2. Rules of Classification for In Vitro Diagnostic Medical Device

6. Grouping

    1. Grouping for General Medical Device 
    2. Grouping for In Vitro Diagnostic Medical Device

7. Conformity Assessment for Medical Device

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

9. Information on Fee Structure for Medical Device Registration

10. Classification and Registration Technical Committee Meeting 

b. 2023 Meeting Decision 
c. 2024 Meeting Decision
         i. February 2024 

11. New information and announcement

12. Check status of registration

13. Registration Statistic (Year 2023)

14. Frequently Ask Questions (FAQs) – under revision

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

a. Registration Unit email address:
i. General email:  [email protected]
ii. IVD email:  [email protected]
iii. Officers’ email and contact number: BKPP Staff Directory
b. Registration Unit telephone number: 
i. Extension line: +603 8230 0376 
ii. Puan Aidahwaty Ariffin @ Aidahwaty M.Olaybal, A.M.N. (BKPP Director):
        •  Office Number: +603 8230 0341 or
        •  HP Number (Whatsapp only) : +6016 333 7031
c.  For assistance related to [email protected]+ system technical issues, kindly submit ticket via [email protected]+ Helpdesk
Medical Device Registration Unit (MEDRU)
Pre-Market Control Division, MDA
Information is updated on 17 May 2024