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TRAININGS FOR CONFORMITY ASSESSMENT BODY (TRAININGS SANCTIONED BY THE MEDICAL DEVICE AUTHORITY)

Greetings from the Authority.

 

This is to announce that the trainings are now opened for registration. The trainings will be organized in OCTOBER 2021.

 

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)

:

OCTOBER 25 & 26, 2021 (MONDAY & TUESDAY)

Time

:

08.30 AM - 05.00 PM

Platform

:

ONLINE TRAINING (MDA E TRAINING & ZOOM / MS TEAMS)

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;

   

(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 OCTOBER 20, 2021 (Wednesday).

       

To download the training programme and registration form, click  HERE

 

 

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

 

Date (Day)

:

OCTOBER 27, 2021 (WEDNESDAY)

Time

:

08.30 AM - 05.00 PM

Platform

:

ONLINE TRAINING (MDA E TRAINING & ZOOM / MS TEAMS)

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;

   

(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 OCTOBER 20, 2021 (Wednesday).

       

To download the training programme and 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)

:

OCTOBER 28, 2021 (THURSDAY)

Time

:

08.30 AM - 05.00 PM

Platform

:

ONLINE TRAINING (MDA E TRAINING & ZOOM / MS TEAMS)

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;

   

(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 OCTOBER 20, 2021 (Wednesday).

       

To download the training programme and registration form, click  HERE

 

 

TRAINING ON REMOTE AUDIT (FOR THE PURPOSE OF ESTABLISHMENT LICENSING UNDER THE ACT 737)

 

Date (Day)

:

OCTOBER 29, 2021 (FRIDAY)

Time

:

08.30 AM - 05.00 PM

Platform

:

ONLINE TRAINING (MDA E TRAINING & ZOOM / MS TEAMS)

Note

:

(1)

This training shall be attended by fresh eligible participants who want to perform remote audit;

   

(2)

The registration will be closed on AUGUST 16, 2021 (Thursday).

   

(3)

If task group & individual assignment submitted, Certificate of Proficiency will be awarded and the certificate can be used for the purpose of registration under the Act 737;

   

(4)

The registration will be closed on OCTOBER 20, 2021 (Wednesday).

       

To download the training programme and registration form, click  HERE

 

 

To book a seat, please complete the provided Registration Forms. An invoice (for payment purpose) will be issued accordingly, upon the acceptance of the Registration Form.

Reminder: Please take note on the different names of Registration Forms.

 

Note:

  • Any amendments to the training program depends on current situation and government policies.

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

CAB TRAINING (cab.training@mdb.gov.my) at 03-8230 0395 / 0240 / 0211 / 0318

Thank you.

 

 

 

 

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  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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  • Last Modified: 18 October 2021.
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