Application
Application for Registration
Regulation 4, MDR 2012
(1) Any person who intends to be a conformity assessment body shall comply with the requirements as specified in Fourth Schedule and shall apply for registration to the Authority.
(2) An application for registration of a conformity assessment body shall be made in forms to be determined by the Authority
(3) An application for registration of a conformity assessment body shall be accompanied with the following:
(a) application fee as specified in Fifth Schedule;
(b) documents or information as specified in forms to be determined by the Authority; and
(c) any additional information, particulars or documents as may be required by the Authority.
(d) Any additional information, particulars or documents required by the Authority under paragraph (3)(c) shall be provided by the applicant within thirty days from the date of request by the Authority
The list of CAB is available on our website. Besides the list of CAB, you will also find other useful information.
ISO 13485 certificate issued by registered CAB shall be submitted for registration of medical devices. For further information on the requirement of QMS for medical device registration, please refer to Third Schedule of MDR2012.
CAB Application
Requirement
The requirements for registration of CAB are provided in Sections 10 and 11 Act 737 and Regulations 8, 9 and 10 of MDR2012. Detailed requirements for registration of CAB are as stipulated in Fourth Schedule of MDR2012 which includes:
(i) requirements on organization;
(ii) requirements on resources and technical competency;
(iii) requirements on independence and impartiality; and
(iv) requirements on quality management system.
Please refer to Medical Device Regulation 2012 Fourth Schedule for the Requirements for the Registration of Conformity Assessment Bodies for further reference.
Application
Application for the registration of CAB is fully online via our new upgraded online system MeDC@St 2.0.
Fee
All applications for Conformity Assessment Body registration under Medical Device Act 2012 (Act 737) will be charged the application fee of RM 1,500 per submission and RM 8,000 upon approval for registration as registration fee.
Fees are to be charged to the applicant as stated in Table of Fees, Part IV, Fifth Schedule of Medical Device Regulation 2012.
The fee payable for an application of a CAB: RM 1,500
The fee payable for the registration of a CAB: RM 8,000
Method of Payment
The payment shall be made through bank draft. The Authority will not accept cash payment. The bank draft shall be made payable to "KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN" and courier to;
KETUA EKSEKUTIF
PIHAK BERKUASA PERANTI PERUBATAN
KEMENTERIAN KESIHATAN MALAYSIA
TINGKAT 6 PRIMA 9, PRIMA AVENUE II
PERSIARAN APEC, 63000 CYBERJAYA
SELANGOR DARUL EHSAN
Information on submission purpose of ”CAB Application/ Registration Fee” and Phone No. of the Person Responsible must be written at the back of the bank draft but not in the table. A receipt of payment will be issued once the bank draft is accepted by the Authority.
To view the guidance please clicks HERE!
CAB Personnel
All technical personnel of the conformity assessment body shall be registered with the Authority. Any additional personnel who wish to be extending their registered scope as Technical Personnel of the CAB of the Act 737 shall apply the registration to the Authority. (This is not applicable to the non-registered CAB)
Requirement
(1) Qualification of the technical personnel of the conformity assessment body shall have successfully completed a university or a technical college degree or equivalent qualification in one or more of the following fields,
(i) medical physics, biomedical engineering;
(ii) biology or microbiology or biotechnology;
(iii) chemistry or biochemistry;
(iv) computer or software technology;
(v) electrical, mechanical or bioengineering;
(vi) human physiology;
(vii) medicine, dentistry, biomedical;
(viii) pharmacy;
(ix) physics or biophysics; or
(x) other relevant fields.
(2) The technical personnel shall have a minimum of four years (4 years) work experience in the following:
(i) Working in closely related industries and the workplace such as research and development and manufacturing;
(ii) Working in the application of the device technology and its use in healthcare services and with patients;
(iii) Testing of medical device concerned for compliance with the relevant national or international standards;
(iv) Conducting performance testing, evaluation studies or clinical trials of medical device.
(v) Substantial relevant experience in e.g. the diagnostic, medical devices or pharmaceutical industries, the health care professions, medical laboratories or test institutes,
(3) If the technical personnel have completed appropriate post tertiary education, the number of years for total experience may be reduced as follows:
Masters - 1 year;
PhD - 3 years
(4) As an equivalent to a degree in the relevant product or medical area, a lower level of tertiary qualification or a non-related degree supported by a minimum of eight years’ experience in the technological area or by a minimum of five years’ experience in the technological area when combined with further independently examined technical training is accepted.
(5) The technical personnel shall have attended training sanctioned by the Authority on statutory requirements, including subsequent updates in the event of significant changes, in medical device regulation 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;
(6) The technical personnel shall have passed appropriate training on auditing of relevant quality management system for medical device as determined by the Authority;
(7) The knowledge of technical personnel would be most likely on the following:
(i) Proven knowledge of medical devices law, other relevant regulations and relevant guidance documents;
(ii) Proven knowledge of quality management procedures, especially of relevant standards acquired through successful participation in relevant training courses and/or practical experience;
(iii) Knowledge of the current status of applicable and relevant product-related standards;
(iv) Technical knowledge and experience of the design, manufacture, and quality control of medical devices and in-vitro diagnostics;
(v) Risk assessment and management as applied to medical devices, including relevant standards as well as the use of risk management tools encompassing the entire medical device lifecycle
Application
Application for the registration of additional scope or technical personnel/ auditor is fully online via our new upgraded online system MeDC@St 2.0.
Fee
An application is only for one (1) personnel only. If more than one (1) personnel, please use another application form. Personnel who are applying under one (1) application must be from one (1) CAB. If the CABs are different, please apply and use in separate application form. All applications will be charged RM 100 per scope applied per personnel.
Method of Payment
The payment shall be made through bank draft. The Authority will not accept cash payment. The bank draft shall be made payable to "KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN" and courier to;
KETUA EKSEKUTIF
PIHAK BERKUASA PERANTI PERUBATAN
KEMENTERIAN KESIHATAN MALAYSIA
TINGKAT 6 PRIMA 9, PRIMA AVENUE II
PERSIARAN APEC, 63000 CYBERJAYA
SELANGOR DARUL EHSAN
Information on submission purpose of ”Technical Personnel Registration Fee” and Phone No. of the Person Responsible must be written at the back of the bank draft but not in the table. A receipt of payment will be issued once the bank draft is accepted by the Authority.
To view the guidance please clicks HERE!
Re-Registation
For the purpose of Conformity Assessment Body registration, it refers to the conditions of the CAB registration. In this case, Authority shall register the CAB and keep the registration in the Register for a period of three years from the date of registration unless the registration is cancelled by the Authority before its expiry.
Conformity Assessment Body must resubmit a registration application 12 months prior to the expiry date of the registration.
Note: Please take necessary action and submit online application as soon as possible. Should there be any delays in CAB re-registration approval, the Authority will not be liable for any claims made by CAB.
Fee
All fees are same as stated in Table of Fees, Part IV, Fifth Schedule of Medical Device Regulation 2012 for Conformity Assessment Body application and registration.
The fee payable for an application: RM 1,500
The fee payable for the registration: RM 8,000
Method of Payment
The payment shall be made through bank draft. The Authority will not accept cash payment. The bank draft shall be made payable to "KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN" and courier to;
KETUA EKSEKUTIF
PIHAK BERKUASA PERANTI PERUBATAN
KEMENTERIAN KESIHATAN MALAYSIA
TINGKAT 6 PRIMA 9, PRIMA AVENUE II
PERSIARAN APEC, 63000 CYBERJAYA
SELANGOR DARUL EHSAN
Information on submission purpose of ”CAB Application/ Registration Fee” and Phone No. of the Person Responsible must be written at the back of the bank draft but not in the table. A receipt of payment will be issued once the bank draft is accepted by the Authority.
To view the guidance please clicks HERE!
