The Conformity Assessment Body (CAB) plays a vital role in issuing various certifications and carrying out technical assessments required for successful registration and distribution of your medical devices and IVDs.
This part of the blog series introduces the Medical Device Authority (MDA's) requirement for CAB certification. The of the series will take you through the role of CABs in device registration and approval in Malaysia.
The CABs are entitled to perform the assessments under the below regulations -
- Medical Device Act 2012 (Act 737)
- Medical Device Regulations 2012
- Circular Letter of the MDA No.2/2014 on Conformity Assessment by way of Verification
- ISO 13485, Medical Device – Quality Management Systems (QMS) – Requirements for Regulatory purposes
The entities should be registered as Conformity Assessment Body (CAB) with the Medical Device Authority (MDA), Malaysia, to evaluate the device manufacturers or other stakeholders involved in a device supply chain. The CAB must be a registered entity in Malaysia, evaluated and approved by the MDA and is continuously monitored by the Agency. The person responsible for the management and operations shall be a Malaysian citizen.
The MDA clearly defines the requirements for an entity to act as a Conformity Assessment Body (CAB) in Malaysia. The requirements are defined in relation to:
- The structure and composition of the organization acting as a CAB
- The resources of the CAB and the technical competency of the personnel
- Independent and impartial nature of the operations – procedures, liabilities and confidentiality
- The required Quality Management Systems for carrying out conformity assessments
- Product testing, in case the CAB also carries out testing as a part of conformity assessment
- Process of how the CAB would carry out conformity assessment
- Communication of CAB changes with the clients and the MDA
- Communication arrangements between the client and the MDA on changes that may impact the compliance
The entity intending to obtain the CAB registration shall submit the application through the online system available at the MDA Portal, www.mda.gov.my, Medical Device Centralised Online Application System (MeDC@St) along with the application fee. Any request from the MDA to submit the missing or additional information shall be submitted within 30 days from the date of such request or the application will be considered as withdrawn. The applicant must make a new application unless an extension to timeline for submitting additional information is granted by the MDA.
The Agency may inspect the premises the applicant intends to use. If the applicant is approved by the MDA, a registration fee shall be paid. Only after the registration fee is received by the MDA, a registration certificate would be issued.
Once registered, the CAB can start accepting the applications from various stakeholders for certifications and registering their devices in Malaysia.
Read part 2 of the article to know the CAB’s role in registering your device or IVD with the MDA.
Are you aiming to launch your medical device or IVD in the Malaysian market? Reach out to a Regulatory expert. Stay informed. Stay compliant.