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:-

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 

• Possible ways of registering IVD staining kits
• Possible ways of registering Microbiological Culture Media

11. New information and announcement

1. How to check whether a device is registered or not
2. 
   

•  Office Number: +603 8230 0341 or
•  Handphone Number: +6016 333 7031