SEMINAR BY THE MEDICAL DEVICE AUTHORITY 2022

REGULATORY UPDATES AND FACILITATION TOWARDS ADDRESSING THE CHALLENGES OF THE COVID-19 PANDEMIC 

MARCH 31, 2022

FIRST ANNOUNCEMENT

 

OVERVIEW

This will be the spearhead 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 information on medical devices enthralling authoritative topics and invaluable experiences from the industry players.

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

We are pleased to announce the commencement of the one-day seminar entitled” Regulatory Updates And Facilitation Towards Addressing The Challenges Of Covid-19 Pandemic” on the 31st of March 2022.

OBJECTIVES

The objectives of this seminar are:

  • To share information on regulatory requirements on medical device regulations.
  • To provide guidance on 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 ensure the compliance of the regulatory requirement to the Act and regulations under it.
  • To share experience and initiatives taken on how to comply with the recent authority approval route from the view of the industry during the COVID-19 situation.

 

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 three-seminar series are as follows.

Series

Date

Location

Registration Form

1

31 March 2022

Klang Valley

Open Now!

 CLICK HERE

2

5 July 2022

Pulau Pinang

(According to minimum satisfactory response)

Will be open on

1st of May 2022

3

4 October 2022

Johor

(According to minimum satisfactory response)

Will be open on

1st of August 2022

 

AGENDA/TENTATIVE

The following seminar Agenda is preliminary and subject to change.

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 – 10.30 am

What’s new in the Medical Device Premarket Requirements?

10.30 – 11.00 am

Short break

11.00 – 12.15 am

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

  • Overview of Code of Advertisement

12.15 – 1.00 pm

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

  • GHWP
  • AMDC

1.00 – 2.00 pm

Lunch Break

2.00 – 3.00 pm

Safety And Performance Issues On Medical Device Related To COVID-19 Outbreak

3.00 – 4.00 pm

Authority Approval for Medical Device During COVID-19 Pandemic Situation: An Establishment Sharing Session

  • COVID-19 Test Kit Approval (Special Access & Conditional Approval)

4.00 - 4.30 pm

Short break

4.30 - 5.00 pm

Panel Q&A

5.00 pm

Adjournment

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 on March 17, 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 printable ticket for 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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