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  • MEDICAL DEVICE WEBINAR 2020: NEW MEDICAL DEVICE REGULATIONS UNDER ACT 737: ADVERTISEMENT AND POST MARKET REQUIREMENTS - AUGUST 17, 2020

MEDICAL DEVICE WEBINAR 2020: NEW MEDICAL DEVICE REGULATIONS UNDER ACT 737: ADVERTISEMENT AND POST MARKET REQUIREMENTS - AUGUST 17, 2020

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MEDICAL DEVICE WEBINAR 2020

NEW MEDICAL DEVICE REGULATIONS UNDER ACT 737: ADVERTISEMENT AND POST MARKET REQUIREMENTS

AUGUST 17, 2020

 

FIRST ANNOUNCEMENT

OVERVIEW

The Medical Device Webinar 2020 on New Medical Device Regulations under Act 737: Advertisement and Post Market Requirements will provide a platform for medical device establishments, medical device industry representatives, conformity assessment bodies, and stakeholders to discuss and share information on new regulations.

MDA sincerely extends an invitation to you to participate in the upcoming webinar. 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.

Medical Device Authority (MDA) is pleased to announce a one-day webinar in August 17, 2020, entitled “New Medical Device Regulations under Act 737: Advertisement and Post Market Requirements".

OBJECTIVES

The objectives of this webinar are:

  • To disseminate information on the latest development on ASEAN Medical Device Directive.
  • 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 share knowledge on how to comply with the new PMS regulation from the view of CAB and industry.
  • To share experience in regulating post market activities from ASEAN member regulatory authority.

TARGET AUDIENCE

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

  • Manufacturers, authorized representatives, importers, and distributors;
  • Conformity Assessment Bodies (CABs);
  • Medical device industry representatives;
  • Interested individuals.

DATE AND TIME

This webinar is intended to be held on August 17, 2020 from 8.30 a.m. to 5.00 p.m.

 WEBINAR PLATFORM

The webinar will be webcast live using MS TEAMS platform and the link will be provided in your confirmation email if you registered to view the webcast.

 AGENDA/TENTATIVE

The following webinar Agenda is preliminary and subject to change.

Time

Topic

8.30 – 8.55 am

Registration

8.55 – 9.00 am

Briefing

9:00 – 9:15 am

Opening Ceremony by Chief Executive of MDA

9.15 – 9.45 am

Updates on Medical Device Act, Regulations and Circular Letters

- Malaysia rectification on AMDD

9.45 - 10.45 am

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

- Overview of COA

- What have been done

- Comments

- Actions

10:45 – 10:50 am

Break

10.50 – 11.50 am

Implementing the New Medical Device Regulations on “Duties and Obligations Of Establishments“, P.U.(A) 318 on the 1st of July. What’s Next?

11.50 – 1.00 pm

Medical Device Regulations of and Duties and Obligations of Establishments:

Walkthrough with MDA (MPR, Complaint Handling)

1:00 – 2:00 pm

Lunch Break

2.00 – 3.00 pm

Medical Device Regulations of and Duties and Obligations of Establishments:

(FCA & FSN, Medical Device Recall)

3.00 – 4.00 pm

How to comply with the new PMSV regulation: Feedback from industry and CAB (context on MDA regulation)

4.00 – 5.00 pm

Sharing of experience on Regulating PM Activities in Singapore Medical Device Regulations of and Duties and Obligations of Establishments 

5.00 – 5.15 pm

Wrap Up and Adjournment

 

REGISTRATION

Webinar fee for per participant: RM 700

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 13rd August 2020.

*Registration Closed

Limited to 150 participants.

Registration of participants will be on a first-come-first-served basis. Upon payment confirmation, MDA will provide a link to join the webinar program.

CONTACT

For questions regarding the webinar please contact:

Should you have any enquiries, please do not hesitate to contact the Training Secretariat:

trainingpackage@mda.gov.my or 03-8230 0211.

 

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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