On March 26, 2025, the Malaysian Medical Device Authority (MDA) issued Circular 1/2025, which outlines the conformity assessment procedure for medical devices approved by recognized foreign regulatory authorities.
The MDA recognizes the approvals for medical devices issued by the following recognized foreign regulatory authorities:
| Competent Authority | Approvals |
| EU / EU NB | For Class B via EC certificates issued according to: - Directive 93/42/EEC Annex II section 3 or Annex V for Class IIa devices; or - MDR Annex IX Chapter I and Chapter III or MDR Annex XI PART A for Class IIa; or - Directive 98/79/EC Annex IV or Annex V with Annex VII for List B and self-testing IVDs; or - IVDR Annex IX Chapter I and Chapter III for Class B IVD For Class C and D via EC certificates issued according to: - Directive 93/42/EEC Annex II section 3 or Annex III with Annex V for Class IIb; or - MDR Annex IX Chapter I and Chapter III, including assessment of technical documentation for implantable, or MDR Annex X coupled with Annex XI PART A for Class IIb; or - Directive 93/42/EEC Annex II section 3 and 4 for Class III; or - MDR Annex IX Chapter I and Chapter III, including assessment of the technical documentation for Class III; or - Directive 90/385/EEC Annex II section 3 and 4 for Active Implantable Medical Devices; or - Directive 98/79/EC Annex IV including sections 4 and 6 for List A IVDs; or - IVDR Annex IX Chapter I and Chapter III, including assessment of technical documentation for Class D IVD - Directive 98/79/EC Annex IV or Annex V with Annex VII for List B and selt-testing IVDs; or - IVDR Annex IX Chapter I and Chapter III, including assessment of technical documentation for companion diagnostics, self-testing & near-patient testing devices, or IVDR Annex X coupled with Annex XI (except section 5) for Class C IVD. |
| Japan / MHLW | - Pre-market certification (Ninsho) from a Japanese registered certification body; or - Pre-market approval (Shonin) from MHLW) |
| AU / TGA | - ARTG Registration Certificate |
| Canada / HC | - Health Canada License |
| US / FDA | - 510(k) clearance ; or - Premarket approval (PMA) |
| UK / MHRA | For Great Britain - UK Conformity Assessed (UKCA); or - EC certificates issued according to recognized approvals as listed in the above EU NB For Northem Ireland - EC Certificates issued according to recognized approvals as listed in the above EU NB; or - UK Northem Island (UKNI) and EC certificates issued according to recognized approvals as listed in the above EU NB |
For medical devices approved by the aforementioned recognized foreign regulatory authorities, a simplified conformity assessment procedure will be followed based on compliance evidence approved by the device manufacturer. However, medical devices that have been granted special approval for market release are not eligible for the simplified conformity assessment procedure for registration purposes.
This circular has been in effect since March 11, 2025.
Please refer to the attached document below.
If you have any questions about medical devices,
please contact us with the below.
ra@jnmglobal.net
info@jnmglobal.net