HANDS-ON WORKSHOP Efficient Way to Prepare for MDA Documentation Submissions

OFFICIAL ANNOUNCEMENT

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WORKSHOP DETAILS

Date (Day): 26 - 29 September 2022 (Monday – Thursday)

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.

PROGRAMME OUTLINE

MODULE 1 (Licensing)
Date (Day)	26^th September 2022 (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 – 10.45 am	New Application of Establishment License (Hands-On MeDC@St)
10.45 – 11.00 am	Short Break
11.00 – 11.45 pm	Renewal of Establishment License
11.45 – 1.00 pm	Renewal of Establishment License (Hands-On MeDC@St)
1.00 - 2.00 pm	Lunch Break
2.00 – 2.15 pm	Amendment Major and Minor of Establishment License
2.15 – 3.00 pm	Amendment Major and Minor of Establishment License (Hands-On MeDC@St)
3.00 - 3.15 pm	Short Break
3.15 – 3.30 pm	Surrender of Establishment License
3.30 – 4.15 pm	Surrender of Establishment License (Hands-On MeDC@St)
4.15 - 4.30 pm	Change of Ownership Application
4.30 - 5.00 pm	Change of Ownership Application (Hands-On MeDC@St)
5.00 pm	End of workshop
MODULE 2 (Registration)
Date (Day)	27^th September 2022 (Tuesday)
Time	Topic
8.30 – 8.55 am	Participant Registration
8.55 – 9.00 am	Program Briefing
9.00 - 9.45 am	Product classification
9.45 - 10.15 am	Combination product
10.15 - 10.30 am	Short Break
10.30 – 11.45 am	Medical Device Registration Process (Verification Process & Full Conformity) Process Flow of Verification Process & Full Conformity a. Classify b. Group
11.45 – 1.00 pm	Medical Device Registration Process (Verification Process & Full Conformity) c. Conformity Assessment i. QMS (ISO 13485, GDPMD) ii. PMS iii. Technical Documentation iv. DoC
1.00 - 2.00 pm	Lunch Break
2.00 – 3.30 pm	Re-registration of Medical Device
3.30 - 3.45 pm	Short Break
3.45 - 5.00 pm	Update on Change Notification
5.00 pm	End of workshop

MODULE 3 (Post-Market)
Date (Day)	28^th September 2022 (Wednesday)
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 4 (Industry Facilitation)
Date (Day)	29^th September 2022 (Thursday)
Time	Topic
8.30 – 8.55 am	Participant Registration
8.55 – 9.00 am	Program Briefing
9.00 – 10.30 am	Certificate Free Sale (CFS) & Manufacturing Certificate (MC) – Export Only Manufacturer or OEM Manufacturer
10.30 – 10.45 am	Short Break
10.45 – 11.45 am	Notification for Export Only Medical Device
11.45 – 12.05 pm	Notification for Special Access Medical Device
12.05 - 12.30 pm	Notification for Custom-Made Medical Device
12.30 – 2.00 pm	Lunch Break
2.00 – 3.15 pm	Notification for Clinical Research Use
3.15 – 3.30 pm	Short Break
3.30 – 4.00 pm	Notification for the Purpose of Demonstration for Marketing
4.00 – 4.30 pm	Notification for the Purpose of Education
4.30 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 19 SEPTEMBER 2022.
Training fee per participant: RM 1,300/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 0240 / 0355 / 0211

Updated: 5th September 2022