Certification - Medical Devices
What is Product Verification?
Product verification or also known as Conformity Assessment by Way of Verification is an assessment of the level of compliance of a medical device to the requirements specific to the device as well as to the requirements specified by the Medical Device Authority (MDA) of Malaysia prior to placement of the device in the Malaysian market.
Product verification is carried out for medical devices that are intended to be registered with the Malaysian Medical Device Authority by Local Manufacturers of those devices or by the Local Authorised Representative of the foreign manufacturer of those devices. Registration of medical devices with MDA is done online via the Medical Device Centralised Online Application System (MeDC@St).
The Product Verification is the fastest and simplest way of conformity assessment of a medical device. MDA approved conformity assessment of medical devices can only be carried out by Conformity Assessment Bodies (CABs) that have been approved by MDA as per Section 10 of the Malaysia Medical Device Act 2012 (Act 737).
- Pre-requisite for Product Verification?
- How is a medical device eligible for Product Verification?
- What about Class A medical devices?
- What is needed to be submitted for Product Verification?
Pre-requisite for Product Verification?
Prior to engaging KGS to carry out Product Verification for a medical device:
- The Local Manufacturer shall have a valid ISO 13485 Certificate
- The Local Authorised Representative shall have a valid GDPMD certificate
- Both the Local Manufacturer and Local Authorised Representative shall have valid establishment license issued by the Malaysian Medical Device Authority
How is a medical device eligible for Product Verification?
For a device to be eligible to proceed for Product Verification, the following criteria shall be satisfied:
- The medical device must already be having pre-market approval or has already been subjected to conformity assessment by a recognized foreign regulatory authority or notified body as specified in the Table 1 of the MDA Circular 2/2014.
- The medical device shall be of Class B, C or D
What about Class A medical devices?
Class A medical devices are exempted from conformity assessment procedures as per the Medical Device (Exemption) Order 2016, hence, can be registered with by MDA directly via the Medical Device Centralised Online Application System (MeDC@St).
What is needed to be submitted for Product Verification?
The following documents shall be submitted for purpose of Production Verification:
- AR/Manufacturer establishment license that has been issued by MDA and having validity
- Valid MDQMS (ISO 13485) certificate of the manufacturer of the device
- Valid pre-market approval from the recognised foreign regulatory authorities as specified in Table 1 of MDA Circular 2/2014 and/or valid CE mark certificate
- Declaration of the Post-Market Surveillance (PMS) for the medical device to highlight any reported ongoing incident globally (if any) and/or incidents in the last 3 years from the time of application (if any)
- Technical documentation which includes the Common Submission Dossier Template (CSDT) and the Essential Principles of Safety Performance (EPSP)
- Declaration of Conformity (DoC)