WORKSHOP DETAILS

Date (Day):

1)      23rd October 2023 (Monday) – Documentation Submissions Post Market

2)      24th October 2023 (Tuesday) - Documentation Submissions Registration

3)      30th October 2023 (Monday) - Documentation Submissions Licensing

               

Time         : Refer each module

Venue       : Meranti Room, Level 6, MDA, Cyberjaya

 

OVERVIEW

This workshop provides a face-to-face platform for medical device establishments, medical device industry representatives, conformity assessment bodies, and stakeholders to have an in-depth understanding of the regulatory requirements of the Medical Device Authority (MDA) based on Act 737, Medical Device Regulation 2012, Medical Device Regulation 2019 and Medical Device (Exemption) Order 2016.

The workshop is mindfully curated to assist the industry in effectively preparing documents required by the authority for better submission and fewer errors. This workshop also gives guidance on how to use the online systems created by MDA such as Medical Device Centralised Online Application System (MeDC@St) and Medical Device Centralized Reporting System (MeDCReSt). This workshop is beneficial to establishments, the medical device industry, and especially new start-up companies in the successful application of establishment licenses, product certificates, and reporting.

 

OBJECTIVES

The objectives of this workshop are:

  • To provide guidance on how to comply with Act 737, Medical Device Regulation 2012, Medical Device Regulation 2019, and Medical Device (Exemption) Order 2016.
  • To improve the documentation submission to MDA
  • To provide a tutorial on how to use MDA online system
  • To provide hands-on experience in submission of application/notification
  • To ensure the compliance of the regulatory requirement to the Act and regulations under it

 

TARGET AUDIENCE

This Workshop will benefit all relevant stakeholders who are involved with the medical devices including:

  • Manufacturers, authorized representatives, importers, and distributors;
  • Medical device industry representatives;
  • Designated persons; and
  • Interested individuals.

 

MODULE 1 (Post-Market)

Date (Day)

23rd October 2023 (Monday)

Time

Topic

8.30 – 8.55 am

Participant Registration

8.55 – 9.00 am

Program Briefing

9:00 – 10.15 am

Introduction to MeDCReSt

10.15 - 10.30 am

Short Break

10.30 - 11.30 pm

MeDCReSt Module: Mandatory Problem Reporting

11.30 - 12.15 pm

MeDCReSt Module: Field Corrective Action (FCA)

12.15 – 1.00 pm

MeDCReSt Module: Recall

1.00 - 2.00 pm

Lunch Break

2.00 – 2.30 pm

Application on Advertisement

2.30 – 3.30 pm

Code of Advertisement

3.30 - 3.45 pm

Short break

3.45 - 5.00 pm

Labelling

5.00 pm

End of workshop

 

 

MODULE 2 (Registration)

Date (Day)

24th October 2023 (Tuesday)

Time

Topic

8.30 – 8.55 am

Participant Registration

8.55 – 9.00 am

Program Briefing

9.00 - 9.30 am

Product classification

9.30 – 10.00 am

Combination product

10.00 - 10.30 am

Short Break

10.30 – 11.00 am

Overview on Medical Devices Registration Application:

·         Medical Device Registration Process (Verification Process & Full Conformity)

·         Process Flow of Verification Process and full Conformity

- Classify

- Group

Medical Device Registration Process (Verification Process & Full Conformity)

c.         Conformity Assessment

i.       QMS (ISO 13485, GDPMD)

ii.       PMS

iii.     Technical Documentation

iv.       DoC

11.00 – 1.00 pm

Hands-on session for Medical Devices Registration in MeDC@St:

·         Class A

·         Class B

·         Class C

·         Class D

1.00 - 2.00 pm

Lunch Break

2.00 – 3.00 pm

Re-registration of Medical Device

3.00 - 3.15 pm

Short Break

3.15 – 5.00 pm

Hands-on application for change notification

5.00 pm

End of workshop

 

 

MODULE 3 (Licensing)

Date (Day)

30th October 2023 (Monday)

Time

Topic

8.30 – 8.55 am

Participant Registration

8.55 – 9.00 am

Program Briefing

9.00 - 9.30 am

New Application of Establishment License

9.30 – 10.00 am

License conditioning monitoring

10.00 – 10.20 am

Short Break

10.20 – 1.00 pm

Hands-on session for Medical Device Registration Application:

·         New Application of Establishment License (Hands-On MeDC@St)

·         Renewal of Establishment License (Hands-On MeDC@St)

1.00 - 2.00 pm

Lunch Break

2.00 – 5.00 pm

Hands-on session for Medical Device Registration Application:

·         Amendment Major and Minor of Establishment License (Hands-On MeDC@St)

·         Surrender of Establishment License (Hands-On MeDC@St)

·         Change of Ownership Application (Hands-On MeDC@St)

5.00 pm

End of workshop

 

 

**Workshop will focus on hands-on (MeDC@St, MeDCReSt, filling related forms & examples of documents)

 

 

REGISTRATION & TRAINING FEE

  • The closing date for registration is 16th October 2023 (Monday) .
  • Training fee per participant: RM 850/module
  • To register, please click HERE.
  • Upon acceptance of the registration, an invoice (for payment purposes) together with details of the payment method will be issued accordingly
  • Registration of participants will be on a first-come-first-served basis.
  • Upon payment confirmation, MDA will provide the workshop ticket through email.
  • Once paid, the registration fee is non-refundable.

 

CONTACT

For enquiries, please contact trainingpackage@mda.gov.my or 03-8230 0307

 

Updated: 22nd September 2023