MANAGEMENT SYSTEM CERTIFICATION
What is ISO 13485?
ISO 13485 is the standard for a Quality Management System (“QMS”) for the design and manufacture of Medical Devices. This standard is design to be use by manufacturer in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
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What is GDPMD?
According to the Regulatory Requirements for Medical Device Safety & Performance, Appendix 4 Schedule 3 Medical Device Regulations 2012, GDPMD specifies the requirements for a quality management system to be established, implemented and maintained by an establishment in carrying out activities in medical device supply-chain to comply with Malaysian medical device regulatory requirements as stipulated in Medical Device Act 2012 (Act 737).
GDPMD requires an establishment to demonstrate its ability to maintain quality, safety and performance of medical devices in compliance with the Malaysian medical device regulatory requirement throughout the supply-chain. It shall be used by both the internal and external parties to determine the ability of an establishment to meet the requirements specified within.
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Benefit of GDPMD
- Quality, safety and performance of medical device during all aspects of medical device supply-chain are appropriately managed and controlled.
- Meet regulatory requirements and customer expectations.
- Consistency to proper storage, handling, distribution and traceability.
- Improve operation efficiency through continual improvement processes.
GDPMD requirements (Part 1 to Part 6) :
Part 1 : Preliminary
Part 2 : Organization and GDPMD Regulatory Compliance System
Part 3 : Establishment Responsibilities
Part 4 : Resource Management
Part 5 : Supply Chain and Device Specific
Part 6 : Surveillance and Vigilance
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PRODUCT REGISTRATION
What is Full Conformity Assessment?
Conformity assessment is a systematic and ongoing examination of evidence and procedures to ensure the safety, performance, benefit and risk of medical devices. It is also to ensure manufacturing compliance to essential principles of safety and performance (EPSP) and requirements of the Medical Device Act 2012 (Act 737).
Full conformity assessment process is applicable to medical devices and IVD medical devices which not obtained approval by recognized foreign regulatory authorities or notified bodies listed in Table 1: Recognized foreign regulatory authorities or notified bodies and the respective approval types eligible for conformity assessment by way of verification (Source: Circular Letter No 2, Year 2014) in accordance with the requirements stipulated in Section 7(1) (a) of Act 737.
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Full Conformity Assessment Process Flow :
What is Conformity Assessment by Way of Verification?
Verification process is a conformity assessment procedure by way of verifying the evidence of conformity of medical device that has been approved by foreign regulatory authority or notified body recognized by MDA as per stated in Table 1 Circular Letter No. 2 Year 2014.
Section 7 of Medical Device Act 2012 (Act 737) requires the carrying out of conformity assessment by the conformity assessment body registered within section 10 of Act 737. This is a precondition for having a medical device registered under the Act.
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Conformity Assessment by Way of Verification Process Flow :
Why Choose Genuine Diamond?
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To register a medical device in Malaysia, a manufacturer or importer must engage with a conformity assessment body (CAB) licensed by Medical Device Authority to certify the application. Certified application by CAB will then be submitted to the Medical Device Authority via online registration system called MEDCAST for approval. Before the registration process of a medical device begin, manufacturer or importer shall have an “establishment license” for them to legally sell the medical device as part of requirements by Medical Device Authority. Non-local manufacturer shall appoint an Authorised Representative which will be responsible in managing the registration process.
GDSB are committed to the avoidance of potentially situations regarding conflict of interest. This effort covers all potential sources of conflict of interests that are identified, whether they arise from within GDSB or from the activities of other persons, bodies or organizations. GDSB does not:
- Provide any consultancy service to client.
- Outsourced audits required by the certification process to any organization.
- Offer its services in such a way that the client has the impression that he would gain advantages if a specified consultancy organization were used.
GDSB Core Business :
1. Management system certifications
- 1.1 Quality Managements System for Medical Devices (ISO 13485)
- 1.2 Good Distribution Practice for Medical Device (GDPMD)
2. Product Registration
- 2.1 Full Conformity Assessment
- 2.1 Conformity Assessment by Way of Verification