OVERVIEW

This will be the second seminar of the year 2022 organized by the Medical Device Authority (MDA). This seminar will provide 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.

Medical Device Authority - Centre of Regulatory Excellence (MDA-CoRE) sincerely extends your invitation to participate in the 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 5th of July 2022 in Pulau Pinang (venue to be announced).

OBJECTIVES

The objectives of this seminar are:

  • To share information on regulatory requirements on medical device regulations.
  • To guide how to comply with the medical device (Duties and Obligation of Establishment) Regulation 2019 and medical device (Advertising) Regulations 2019.
  • To provide updates on medical device regulations.
  • To disseminate information on the latest development on ASEAN Medical Device Committee (AMDC) and Global Harmonization Working Parties (GHWP).
  • To assist the compliance of the regulatory requirement to the Act and regulations under it.

 

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 three locations throughout peninsular Malaysia to provide accessibility to the industry players. This includes Penang (Northern Region), Klang Valley (Central Region) & Johor (Southern Region). This seminar is intended to be held from 8.30 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

Pulau Pinang

(TBA)

Open Now!

 CLICK HERE

3

6 October 2022

KLCC

(According to minimum satisfactory response)

Registration open on

1st of August 2022

4

3 November 2022

Johor

(According to minimum satisfactory response)

Registration open on

1st of September 2022

 

AGENDA/TENTATIVE

 

Time

Topic

8.30 – 8.55 am

Participant Registration

8.55 – 9.00 am

Program Briefing

9:00 – 9:15 am

Opening Speech by Chief Executive of MDA

9.15 – 10.15 am

What’s new in the Medical Device Premarket Requirements?

10.15 – 10.45 am

Short break

10.45 – 12.00 pm

The Implementation of Medical Device (Advertising) Regulations 2019 P.U. (A) 317

·         Overview of Code of Advertisement

·         Application of Medical Device Advertisement

12.00 – 1.00 pm

New Local Policies, Regulations, and International Medical Device Regulatory Initiatives Towards Harmonization and Convergence

·         Global Harmonization Working Party (GHWP)

·         ASEAN Medical Device Committee (AMDC)

1.00 – 2.30 pm

Lunch Break

2.30 – 4.00 pm

Safety and Performance Issues on Medical Devices

4.00 - 4.15 pm

Short break

4.15 - 5.00 pm

Panel Q&A

5.00 pm

Adjournment

** topics are subject to change

 

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 JUNE 28, 2022.

To register, please click HERE

Limited to 150 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.

 

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