SEMINAR BY THE MEDICAL DEVICE AUTHORITY ON REGULATORY UPDATES

SEMINAR BY THE MEDICAL DEVICE AUTHORITY ON REGULATORY UPDATES

OCTOBER 12, 2022

FIRST ANNOUNCEMENT

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OVERVIEW

This will be the third seminar of the year 2022 organized by the Medical Device Authority (MDA). This seminar provides a platform for medical device establishments, medical device industry representatives, conformity assessment bodies, and stakeholders to discuss and share knowledge on medical devices’ key regulatory updates, as well as inspire networking between the industry players with the same interest in the medical device. This seminar will provide information on the regulatory updates, the re-registration process of medical devices and also introduce the newly launched system by MDA's Post-Market and Enforcement Division, Medical Device Centralized Reporting System (MeDCReSt), to facilitate the reports from the industry and the public.

Medical Device Authority - Centre of Regulatory Excellence (MDA-CoRE) extends an invitation to participate in this upcoming seminar. It is hoped that this seminar will bring a higher understanding of the regulatory topics presented and encourage healthy interaction between the participants, speakers, and the Authority.

We are pleased to announce the commencement of the one-day seminar entitled “Seminar by The Medical Device Authority on Regulatory Updates” on the 12th of October 2022 in Putrajaya (venue to be announced).

 

OBJECTIVES

The objectives of this seminar are:

  • To provide updates on medical device regulations, acts, and guidelines in Malaysia.
  • To disseminate information on the latest development on ASEAN Medical Device Committee (AMDC) and Global Harmonization Working Parties (GHWP).
  • To share information on regulatory requirements for medical device re-registration in compliance with Act 737.
  • To assist and ease the industry to raise any issues relating to the medical device by making Mandatory Problem Reporting (MPR), Field Corrective Action (FCA), and Recall using the new Medical Device Centralized Reporting System (MeDCReSt).

 

TARGET AUDIENCE

This seminar will benefit all relevant stakeholders who are involved with the medical device including:

  • Manufacturers, authorized representatives, importers, and distributors;
  • Conformity Assessment Bodies (CABs);
  • Medical device associations;
  • Medical device industry representatives;
  • Healthcare institutions or universities;
  • Healthcare professionals (HCPs);
  • Designated persons; and
  • Interested individuals.

 

SEMINAR TIME, DATE & LOCATION

The seminar will be held at 4 locations throughout peninsular Malaysia to provide accessibility to the industry players. This includes Penang (Northern Region), Cyberjaya (Central Region), Putrajaya (Central Region), and Johor (Southern Region). This seminar is intended to be held in 1 day from 8.45 a.m. to 5.00 p.m. The details for the seminar series are as follows.

 

Series

Date

Location

Registration Form

1

31 March 2022

Cyberview Resort & Spa, Cyberjaya

Closed

2

5 July 2022

Bayview Georgetown Hotel, Penang

Closed

3

12 October 2022

Putrajaya

(TBA)

Registration Open Now!

CLICK HERE

4

3 November 2022

Johor

(TBA)

Registration open on

1st of October 2022

 

AGENDA/TENTATIVE

 

Time

Topic

8.30 – 8.55 am

Participant Registration

8.55 – 9.00 am

Program Briefing

9.00 – 9.10 am

Opening Speech by Chief Executive of MDA

9.10 – 10.10 am

“How Does the International Medical Device Organization Influences Our National Policies? What Is MDA Up To?”

Local policies, regulations, and international medical device regulatory initiatives towards harmonization and convergence

(Global Harmonization Working Party (GHWP), ASEAN Medical Device Committee (AMDC))

10.10 – 10.30 am

Short break

10.30 – 12.00 pm

“My Medical Device Registration Certificates are Expiring! What Do I Do Now?”

Re-registration process of medical device

12.00 – 1.00 pm

Q&A Session 1

1.00 – 2.00 pm

Lunch Break

2.00 – 4.00 pm

“My Product Caused an Emergency, Where Do I Go?”

Newly launched reporting system (MeDCReSt), safety and performance issues on medical devices

4.00 - 4.20 pm

Short break

4.20 – 5.00 pm

Q&A Session 2

5.00 pm

Adjournment

** topics are subject to change according to current updates

 

REGISTRATION

Training fee per participant: RM 1,500

Kindly complete the provided Registration Form. Upon acceptance of the Registration Form, an invoice (for payment purposes) together with details of the payment method will be issued accordingly. The closing date for registration & payment is OCTOBER 3, 2022.

To register, please click HERE

Limited to 135 participants.

Registration of participants will be on a first-come-first-served basis. Upon payment confirmation, MDA will provide the confirmation email & Google Form for the test results of the seminar.

 

CONTACT

For questions regarding the seminar please contact:

Training Secretariat: events@mda.gov.my or 03-8230 0240 / 0343/ 0355 / 0211 / 0395.

 

Updated: 8th September 2022

Print

  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Last Modified: 03 October 2022.
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