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
5. Rules of Classification
6. Grouping
7. Conformity Assessment for Medical Device
9. Information on Fee Structure for Medical Device Registration
10. Classification and Registration Technical Committee Meeting
iv. List of products (medical device or non-medical device)
i. February 2024
11. New information and announcement
- Feb 2024 - Medical Device Re-Registration Application: Implementation of Initial MDA Response Within 14 Working Days
- Oct 2023 - Pelaksanaan Penggunaan Sijil Pendaftaran Peranti Perubatan Elektronik Sepenuhnya Bermula 1 November 2023
- June 2023 - MDA Approach on Expired EC Certificate for New Registration and Re-registration of Medical Device
- March 2023 - Withdrawal of Medical Device Registration (New and Re-Register) And Change of Notification Application
13. Registration Statistic (Year 2023)
14. Frequently Ask Questions (FAQs) – under revision
15. For any inquiries, kindly contact us for further assistance:
ii. Aidahwaty Ariffin @ Aidahwaty M.Olaybal, A.M.N. (BKPP Director):
- Office Number: +603 8230 0341 or
- Handphone Number: +6016 333 7031
Pre-Market Control Division, MDA
Information is updated on 13 February 2024