Malaysia MDA Announcement

Malaysia MDA Announcement Updated: 25th August 2020

MDA Changes	Details
Advertisement	All advertisements that promote the medical device to general public needs to attain approval from MDA through email. LOA need to be provided by AR/Manufacturer as part of application. ·        For any non-compliance , AR/Manufacturer may be held liable hence there is a need to check the advertisement if it complies to the requirements. ·        Guidance document for advertisement will be released soon ·        Transition period is provided by MDA tentatively till 31 December 2021.
Mandatory Problem Reporting	New guidance document released. Adverse events occurring overseas do not need to be submitted to MDA if report has been submitted to the Health authority of the country of the incident AND FCA in that country has been executed. In the future, reporting would be done via online.
Distribution Records	New guidance document released. Change on the retention period. More details on what content to include in the Distribution record for General Medical Device and Implants.
Complaint Handling	New guidance document released. More details in the procedure and new complaint template from MDA (Annex B). Contents of what to include in the Complaint form & Retention period for complaints. MDA mentioned during the webinar that Establishment/users who lodged medical device complaints to Manufacturer/Establishment should be copied to MDA via email or online portal. However, this is not stated in guidance document.
FCA/FCN/Recall	New guidance document released. Release of FCA form 2020 template from MDA. Release of Recall form 2020 template from MDA
Other future changes	Upcoming Regulations: Medical Device (General Duties) Regulations 202X – Control of testing, commissioning, maintenance & disposal Designation Medical Device Permit Regulations Compounding offences Regulations   New Policy: Exemption of Conformity Assessment Body Re-Registration of Medical Device Medical Device Novel Technology Medical Gas System   MDA will conduct the conformity assessment instead of CAB under the 3 new policies – Guidance will be provided on the detailed procedures and timeline soon.

Updated: 28th July 2020

Dear Sir/Madam

This Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.

This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following;
a) Medical Device Act 2012 (Act 737); and
b) Medical Device Regulations 2012

c) The Medical Device (Duties and Obligations of Establishments) Regulations 2019

Updated: 22nd July 2020

Ref.no: (35) MDA.600-2/1/4  

MDARIS#63

 

TRAINING BY THE AUTHORITY COMPULSORY COMPETENCY MODULE: INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL (BTP)
 

TRAINING BY THE AUTHORITY

COMPULSORY COMPETENCY MODULE:

INTRODUCTION TO REGULATORY REQUIREMENTS FOR BIOMEDICAL TECHNICAL PERSONNEL (BTP)

INTRODUCTION

This regulatory module is designed to provide participants with the knowledge of medical device regulatory requirements in Malaysia. Biomedical technical personnel, supervisors, and managers who responsible for maintenance, testing & commissioning and disposal of medical device in healthcare institutions and related facilities will highly benefit from this course.

OBJECTIVES

   ·  To provide an overview of the Medical Devices Act 737, and Medical Device Regulation 2012

   ·  To provide the medical device regulatory requirements in a healthcare institute

 TARGET AUDIENCE

  ·    Biomedical Service Provider
  ·    Biomedical Engineering Trainers
  ·    Biomedical, Mechanical, Mechatronics, Electrical, Electronics Engineering graduates
  ·    Technical and Vocational Education and Training (TVET)
  ·    BEM and FEM Managers
  ·    Biomedical Technical Personnel

PROGRAMME OUTLINE

REGISTRATION AND TRAINING FEE

Training fee for per participant: RM 750

·         Inclusive of breakfast, lunch and refreshments (12 August 2020)

·         No meal will be provided on the examination day (13 August 2020)

·         Training fee does not include accommodation & travelling

Kindly complete the provided Registration Form and submit to trainingpackage@mda.gov.my. Upon acceptance of the Registration Form, An invoice (for payment purpose) together with details of payment method will be issued accordingly. The closing date for registration is on 3rd August 2020.

To register, please click HERE

The above new announcement was added to the Medical Device Authority (MDA) webpage. Previous announcements can be found on the Medical Device Authority (MDA) webpage.

Updated: 20th July 2020

Medical Device Authority (MDA) is pleased to announce a one-day webinar in August 17, 2020, entitled “Medical Device Webinar 2020: New Medical Device Regulations under Act 737: Advertisement and Post Market Requirements”  will organize by MDA. The primary objective of the webinar is to enhance the understanding to Medical Device New Regulations by highlighting The Medical Device (Duties and Obligations of Establishments) Regulations 2019 and The Medical Device (Advertising) Regulations 2019.

For more info, please click the link;

https://portal.mda.gov.my/announcement/561-medical-device-webinar-2020-new-medical-device-regulations-under-act-737-advertisement-and-post-market-requirements-august-17,-2020.html

If you have not already signed up for this webinar, now is the time! If you do have colleagues or know of anyone interested in attending this webinar, please share this email with them. Attached herewith is the program flyers for your reference.

We look forward to your participation in this online webinar.

Note;

For any inquiries, please call +603-8230 0211 or +603-8230 0300 (General Line) or email (trainingpackage@mda.gov.my). 

Contact us here for more information of Malaysia MDA announcement