TRAININGS SANCTIONED BY THE MEDICAL DEVICE AUTHORITY (PROFICIENCY TRAININGS) - 16 TO 19 MARCH 2020

TRAININGS SANCTIONED BY THE MEDICAL DEVICE AUTHORITY (PROFICIENCY TRAININGS)

 Greetings from the Authority.

This is to announce that the trainings are now opened for registration. The trainings will be organized in MARCH 2020.

Below are the details of the trainings:

TRAINING ON CONFORMITY ASSESSMENT PROCEDURES ON TECHNICAL DOCUMENTATION & BY WAY OF VERIFICATION (FOR THE PURPOSE OF MEDICAL DEVICE REGISTRATION UNDER THE ACT 737)

Date (Day)

:

MARCH 16 & 17, 2020 (MONDAY & TUESDAY)

Time

:

08.30 AM - 05.00 PM

Venue

:

BILIK SEMINAR 1, LEVEL G, PRIMA 9, 63000 CYBERJAYA

Note

:

(1)

This training shall be attended by fresh eligible participants who want to perform verification and/or full-assessment activities or participants who had

failed the previous training’s examination or those who have the expired Certificate of Proficiency or any personnel from the establishments;

   

(2)

Examination will be introduced and the passing mark is 80%;

   

(3)

If pass, Certificate of Proficiency will be awarded and the certificate can be used for the purpose of registration under the Act 737;

   

(4)

If fail, only Certificate of Attendance will be awarded and the certificate

cannot be used for the purpose of registration under the Act 737;

   

(5)

The registration will be closed on March 9, 2020 (Monday).

To download the Training Programme & Registration Form, click  HERE!

 

TRAINING ON CONFORMITY ASSESSMENT BODY REGISTRATION UNDER THE ACT 737 (MEDICAL DEVICE ACT 2012 & MEDICAL DEVICE REGULATIONS 2012)

Date (Day)

:

MARCH 18, 2020 (WEDNESDAY)

Time

:

08.30 AM - 05.00 PM

Venue

:

BILIK SEMINAR 1, LEVEL G, PRIMA 9, 63000 CYBERJAYA

Note

:

(1)

This pre-requisite training shall be attended by all fresh eligible participants who want to perform ISO 13485 and/or GDPMD audits, verification and/or full-assessment activities or participants who had failed the previous

training’s examination or those who have the expired Certificate of Proficiency or any personnel from the establishments;

   

(2)

Examination will be introduced and the passing mark is 80%;

   

(3)

If pass, Certificate of Proficiency will be awarded and the certificate can be used for the purpose of registration under the Act 737;

   

(4)

If fail, only Certificate of Attendance will be awarded and the certificate cannot be used for the purpose of registration under the Act 737;

   

(5)

The registration will be closed on March 9, 2020 (Monday).

To download the Training Programme & Registration Form, click  HERE!

 

TRAINING ON CONFORMITY ASSESSMENT PROCEDURES ON QUALITY MANAGEMENT SYSTEM & POST-MARKET SURVEILLANCE SYSTEM (FOR THE PURPOSE OF ESTABLISHMENT LICENSING UNDER THE ACT 737)

Date (Day)

:

MARCH 19, 2020 (THURSDAY)

Time

:

08.30 AM - 05.00 PM

Venue

:

BILIK SEMINAR 1, LEVEL G, PRIMA 9, 63000 CYBERJAYA

Note

:

(1)

This training shall be attended by fresh eligible participants who want to perform ISO 13485 and/or GDPMD audits or participants who had failed the previous training’s examination or those who have the expired Certificate of

Proficiency or any personnel from the establishments;

   

(2)

Examination will be introduced and the passing mark is 80%;

   

(3)

If pass, Certificate of Proficiency will be awarded and the certificate can be used for the purpose of registration under the Act 737;

   

(4)

If fail, only Certificate of Attendance will be awarded and the certificate cannot be used for the purpose of registration under the Act 737;

   

(5)

The registration will be closed on March 9, 2020 (Monday).

To download the Training Programme & Registration Form, click  HERE!

To book a seat, please complete the provided Registration Forms and submit it to cab.training@mdb.gov.my. An invoice (for payment purpose) will be issued accordingly, upon the acceptance of the Registration Form.

Note: These proficiency trainings can be attended by any person (CABs, Certification Bodies, Medical Device Industries, Consultant Companies, etc.) who wishes to enlighten his/her proficiency on the Malaysia’s regulatory requirements or to become a medical device auditor and/or technical personnel.

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

WAN HUSNIATI BINTI WAN ABDULLAH (Pn.) at 03-8230 0398 or whusniati@mda.gov.my

MOHD FADHULLAH BIN ABD HALIM (En.) at 03-8230 0356 or fadhullah@mda.gov.my

Thank you.

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