Proficiency Training (CAB)
Introduction
Background
The requirement for Registration of Conformity Assessment Body (CAB) is specified under the Section 10 of Medical Device Act 2012 (Act 737). All CABs shall be registered under this Act to conduct the conformity assessment to the requirements of the medical device law. According to Fourth Schedule of the Medical Device Regulations 2012, the auditors and/or technical personnel of the CAB who are involved in conducting conformity assessment tasks shall have attended training sanctioned by the Authority and have been awarded with the Certificate of Proficiency, which shall be valid for a duration as determined by the Authority, on statutory requirements, including subsequent updates in the event of significant changes, in medical device regulation.
Therefore, this training programme was organized to impart information and/or instructions to improve the participants’ performance and they will gain a good understanding of the key issues relating to conformity assessment, from the principles to the actual requirements that need to be satisfied and also help them to attain a required level of knowledge or skill.
This training program is aimed to educate conformity assessment bodies (CABs) on:
- The requirements of Conformity Assessment Body registration under the Act 737 (Medical Device Act 2012 & Medical Device Regulations 2012)
- The requirement of conformity assessment procedures on Quality management system & post-market surveillance system
- The requirement of conformity assessment procedures on technical documentation & by way of verification
This training is a mandatory course for all auditors of CABs. It is a requirement to fulfil the registration of technical personnel under the Act 737. The requirement is stated in Fourth Schedule of the Medical Device Regulations 2012. No restriction is imposed on them whether they want to attend every course or relevant course to professional development prior to their registrations scope.
Objective
- To comprehend the Conformity Assessment Procedure on Quality Management System (QMS)
- To comprehend the Conformity Assessment Procedure on Post-Market Surveillance System (PMSS)
- To enlighten the CAB on regulatory requirements
General
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; or
- 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; or
- potential auditors of potential CABs are prioritised to attend
Examination will be introduced and the passing mark is 80%. If passed, Certificate of Proficiency will be awarded and the certificate could be used for the registration purpose under the Act 737. In the event of failure, only the Certificate of Attendance will be awarded and the certificate shall not be used for registration purposes under Act 737.
Note: These proficiency trainings can be attended by all people (CABs, Certification Bodies, Medical Device Industries, Consultant Companies, etc.) who wish to enlighten his/her proficiency on the Malaysia’s regulatory requirements or to become a medical device auditor or technical personnel.
Payment
Payment invoice will be released upon submitting the registration.
Payable by Telegraphic Transfer/Direct Bank Transfer or to "KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN". Name and Telephone No. of the applicant must be written at the back of the bank draft but not in the table section.
Please submit the bank draft by hand and attach together with the payment invoice to:
MEDICAL DEVICE AUTHORITY
Ministry of Health Malaysia
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor,
MALAYSIA
T: (03) 8230 0300
F: (03) 8230 0200 Email: cab [DOT] training [AT] mda [DOT] gov [DOT] my
Confirmation of registration will be valid once enclosed with a copy of the bank draft/receipt of payment.
Please submit a copy of the bank draft (.pdf format) to cab [DOT] training [AT] mdb [DOT] gov [DOT] my for our reference.
CASH WILL NOT BE accepted. The Authority will not be responsible for the cash sent or brought to MDA.
Upon payment confirmation, MDA will provide a link to join the training program.
Eamination
In order to measure and determine level of knowledge and awareness of the participants, an examination was introduced. Participants had to answer forty (40) multiple choice questions in one (1) hour. The minimum passing score is 80/100 and Certificate of Proficiency will be awarded to the participants. For those who had failed the examination, they should re-attend the training and re-sitting the examination as required by the Authority.
Participant can choose any day from the tentative dates to repeat your failed examination(s). There will be no fee imposed (no refreshments and meals) and the sessions will be held at the Authority's office. To add, participant has to use their previous given training materials because the Authority will not provide any new training materials for them to refer during the examination.
Note: If the selected date & time are found unsuitable, re-arrangement will be made to suit both parties’ availability.
Updated: 7th November 2022
