Medical Device Assessment
Determine whether the product is a medical device
Appropriately classify the medical device
Appropriately group the medical device
Conduct conformity assessment by CAB and collect evidence of conformity
CAB review and validated the evidence. If the all requirement been fulfilled, CAB shall issue the Medical Device Conformity Assessment Report and Certificate of Conformity
Apply to register medical device at Medical Device Authority website
5.1 Full Conformity Assessment
a) Determine whether the product is a medical device: The determination of the product will be based on the definition of : medical device” in as specified in Section 2 of Act 737 and further elaborated in the Guidance Document on Definition of Medical Device (MDA/GD-01).
b) Appropriately classify the medical device: The classification of medical device should be done according to the rules of medical device classification as specified in First Schedule of Medical Device Regulation 2012 and further elaborated in the Guidance Document on The rules of Classification for General Medical Devices (MDA-GD-04).
c) Appropriately group the medical device: The grouping of medical device should be done according to the rules of medical device grouping as specified in Second Schedule of Medical Device Regulation 2012 and further elaborated in the Guidance Document on Grouping of Medical Device.
d) Conduct full conformity assessment by CAB and collect evidence of conformity: According to Third Schedule of Medical Device Regulation 2012:
i. The evidence of conformity the manufacturer has the valid certification of ISO 13485 issued by CAB approved by Medical Device Authority or Notified Bodies or certification bodies by recognised countries from US, Canada, Japan, Australia and EU.
ii. The evidence of Post-market Surveillance System(PMS) has establish, maintained and implement by manufacturer.
iii. The evidence of conformity has to be collected to demonstrate compliance to applicable Essential Principles of Safety and Performance of Medical Device as specified in Appendix 1 of Third Schedule of Medical Device Regulation 2012 and further elaborated in the Guidance Document on Essential Principles of Safety and Performance of Medical Device (MDA/GD-02);
iv. The evidence of conformity has to be compiled according to the Common Submission Dossier Template (CSDT) as specified in Appendix 2 of Third Schedule of Medical Device Regulation 2012 and further elaborated in the Guidance Document on Common Submission Dossier Template (MDA/GD-03).
v. The Declaration of Conformity according to the template in Appendix 1A of Third Schedule of Medical Device Regulation 2012 has to be duly prepared, signed and stamped.
*Exemption from Conformity Assessment process for Class A medical device according Medical Device (Exemption) Order 2024
e) The CAB has verified or validated evidence during conformity assessment: According to 3rd Schedule of Medical Device Regulation 2012
i. The evidence of conformity has to be verified or validated by the registered CAB;
ii. The CAB has to issue certificate of conformity and the report upon completion of the conformity assessment.
f) Apply to register medical device using Medical Device Authority website:
i. Application for registration of medical device may be made after the criteria are met and the information and supporting documents to support the criteria are available;
ii. Application for medical device registration shall be made via MeDC@St;
iii. Application must create an account before making application via MeDC@St.
(Note: Steps to be taken before making an application for registration of a medical device.)
5.2 Conformity Assessment by way of verification
a) Determine whether the product is a medical device: The determination of the product will be based on the definition of: medical device” in as specified in Section 2 of Act 737 and further elaborated in the Guidance Document on Definition of Medical Device (MDA/GD-01).The intended use/indication for use shall be the same as approved by recognized country.
b) Appropriately classify the medical device: The classification of medical device should be done according to the rules of medical device classification as specified in First Schedule of Medical Device Regulation 2012 and further elaborated in the Guidance Document on The rules of Classification for General Medical Devices (MDA-GD-04).
c) Appropriately group the medical device: The grouping of medical device should be done according to the rules of medical device grouping as specified in Second Schedule of Medical Device Regulation 2012 and further elaborated in the Guidance Document on Grouping of Medical Device.
d) Conduct verification of conformity assessment by CAB and verification evidence of conformity: According to MDA Circular Letter No.2/2014 Conformity Assessment Procedures for Medical Device Approved by Recognised Countries
i. The verification evidence of Authenticity ISO13485 Medical Device Quality Management System(QMS) ,Scope of QMS and validity period of certificate of manufacturer.
ii. The verification evidence of manufacturer Post-market Surveillance System(PMS), list of reported ongoing incident globally(if applicable), list of incidents that have been resolved for past 3 years(if applicable) and date of last audit PMS.
iii. The verification evidence of Technical Documentation as authenticity and validity of CE mark certificate and /or evidence of approval by recognized foreign regulatory authority, Common Submission Dossier Template(CSDT), Intended use on labels and labelling shall be consistent and labelling shall be in accordance with Sixth Schedule MDR 2012.
iv. The verification evidence of Declaration of Conformity(DoC) is prepared according to Appendix 3 Third Schedule MDR 2012.
e) The CAB has verified or validated evidence during conformity assessment: According to 3rd Schedule of Medical Device Regulation 2012
i. The evidence of conformity has to be verified or validated by the registered CAB;
ii. The CAB has to issue certificate of conformity and the report upon completion of the conformity assessment.
f) Apply to register medical device using Medical Device Authority website:
i. Application for registration of medical device may be made after the criteria are met and the information and supporting documents to support the criteria are available;
ii. Application for medical device registration shall be made via MeDC@St;
iii. Application must create an account before making application via MeDC@St.
(Note: Steps to be taken before making an application for registration of a medical device.)