Certification - Medical Devices
MDA Approved Assessments
Full Conformity Assessment
What is Full Conformity Assessment?
Full Conformity Assessment 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.
Full Conformity Assessment 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 Full Conformity Assessment is a very comprehensive method of assessment of a medical device equivalent to a CE mark assessment. 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 Full Conformity Assessment?
- How is a medical device eligible for Full Conformity Assessment?
- What about Class A medical devices?
- What is needed to be submitted for Full Conformity Assessment?
Pre-requisite for Full Conformity Assessment?
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 Full Conformity Assessment?
For a device to be eligible to proceed for Full Conformity Assessment, the following criteria shall be satisfied:
- The medical device is not having pre-market approval or has not 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 Full Conformity Assessment?
Full conformity Assessment in Malaysia is similar to CE certification or US FDA premarket approval application. No predicate device or prior approval can be used as a leverage for this approval or to follow a simplified registration process. In a Full Conformity Assessment, a thorough scientific and regulatory review is conducted to evaluate the safety and effectiveness of medical devices, regardless of risk classification. The following will be assessed comprehensively:
- Medical Device Quality management system (MDQMS):
Consideration will be given to any relevant existing certification and, if not satisfied, KGS may carry out an on-site audit of the manufacturer’s facility. Criteria for acceptance of existing certification shall include the following:
- QMS certificate issued by MDA registered CAB;
- QMS certificate issued by any notified body listed in New Approach Notified and Designated (NANDO);
- QMS certificate issued by certification bodies from reference regulatory countries (US, Canada, Australia, Japan, EU);
- Post-market surveillance system (PMS):
To ensure a PMS is established, maintained and implemented by the establishment. The following processes shall be documented, maintained and implemented by the establishment:
- complaint handling;
- distribution records;
- mandatory problem/adverse event reporting;
- field corrective action; and
- Technical documentation:
A complete Common Submission Dossier Template (CSDT) must be established by the manufacturer. No abridged version will be accepted. Each and every test report and clinical evaluation reports must be made available and submitted when requested, for thorough evaluation. The adequacy of the documented evidence is determined in support of the manufacturer’s declaration of conformity to the EPSP through a review of the CSDT and technical documentation.
- Declaration of conformity:
Medical Devices manufacturers shall attest that its medical device complies fully with all applicable Essential Principles for Safety and Performance (EPSP) and other requirements of Act 737 and the subsidiary regulations under it, documented in a written ‘Declaration of Conformity’ (DOC).