NOVEMBER 2023 REGULATORY OVERVIEW

BY MEDTECH CONSULTING- A SUBSIDIARY OF UNIVERSAL THERAPEUTICS

MALAYSIA

Updates to Medical Device Advertisement Application Process

8th November 2023

All medical device advertisement applications to the Medical Device Authority (MDA) shall be submitted via email to advertisement@mda.gov.my starting 1st December 2023. Hard copy application forms will no longer be processed after this date.

The application form (Annex A) can be downloaded here.

The original MDA announcement can be accessed here. For further enquiries, please contact us at Mtresponder@medtechconsulting.com.my or utilise our contact form here.

Footnotes:

*Notification of Export Only Medical Device: https://www.mda.gov.my/industry/notification-for-export-only-medical-device.html

**Export Certificate Application Process: https://www.mda.gov.my/industry/export-certificate.html

Approaches to Register IVD Analysers

16th November 2023

The Medical Device Authority (MDA) recently published an infographic that describes several options for registration of IVD Analysers in Malaysia.

Outlined below are the three distinct approaches highlighted by the MDA within the infographic:

1.     IVD analysers that are intended specifically by the manufacturer to be used in in vitro diagnostic procedures are classified as Class A. Reagents and kits are classified in their own right.

Examples:

·       Enzyme immunoassay analysers,

·       PCR thermocycler,

·       Microplate reader,

·       Clinical chemistry analyser,

·       Instrument for automated purification of nucleic acids and automated nucleic acid extractor

2.     For analysers registered in conjunction with reagents, calibrators, controls, buffer/washing solutions, product classification should be guided by the Class of the associated reagent.

Examples:

·       Clinical chemistry analyser + Reagent assay + Diluent,

·       Immunoassay analyser-coagulation + D-dimer reagent + D-dimer control

3.     Analysers with independent measuring function, without the need for additional reagents, is classified according to the intended purpose of the analysis (including instrument controls or instrument quality control).

Example:

·       Cell counting analyser used in haematology,

·       Ion-selective electrodes,

·       Instruments measuring blood gases or glucose via its sensors,

·       Specific gravity measurements in urine analysis,

·       Mass spectrometer for bacteria identification,

·       Erythrocyte sedimentation rate analyser

The original MDA announcement, inclusive of the infographic, is accessible here.

For further enquiries, please contact us at Mtresponder@medtechconsulting.com.my or utilise our contact form here.

SINGAPORE

None for the month of November.