PowerPoint Presentation

[Audio] Good day everyone. The topic that I am going to brief you is Good Distribution Practice for Medical Devices ( GDPMD or GDPMDS). This is a standard requirement set by the country authority to elucidate the requirements for an appropriate management and control of distribution activities..

[Audio] In overview, you will learn about What is GDPMD or GDPMDS, Who will be involved in this requirement, why the organization needs to be certified to this requirement and lastly, how does the organization comply with the standard..

[Audio] Before we start to understand GDPMD, let's look at the marketed products for EP Plus and Parvus. These are the marketed medical devices for EP Plus. From principal Vitrolife, all the disposable devices, media and embryoscopes are medical devices. From principal Karo Pharma, the Multi-Gyn Actigel and Multi-Gyn Vaginal Douche are medical devices. And from principal Fidia, all the Hyalo range of products ( Hyalo Regen, Hyalo Skin and Hyalo Start) are medical devices..

[Audio] As for Parvus, We have medical devices from principal Teoxane, where all the Teosyal Fillers are medical devices. We also have from principal 1st SurgiConcept, where all the Spring Thread Sutures are medical devices. And from principal Regen Biotech, the AestheFill are also medical devices..

[Audio] Now we will start to look at What is GDPMD. GDPMD stands for Good Distribution Practice for Medical Devices. In Malaysia, we call it as GDPMD while in Singapore, we will call it as GDPMDS. The extra 'S' stands for Singapore. This briefing will be covering the standard for both Malaysia and Singapore..

[Audio] The objective of GDPMD standard is to ensure the quality, safety and performance of the medical devices throughout the supply chain and distribution processes..

[Audio] This is for your quick glance on our company's certificate. In Malaysia, we are certified through Conformity Assessment Body – BSI, while in Singapore, we are certified through Bureau Veritas ( BV)..

[Audio] Now we look at Who is supposed to be involved in GDPMD. Based on the requirement, certification to GDPMD is required for establishments such as Product Registration Holder or Authorised Representatives, Importers, and Distributors. Both EP Plus and Parvus, we are the Authorised Representatives, Importers, as well as Distributors. Therefore, whoever in the organization that is involved in the medical device business are also required to understand the GDPMD requirements..

[Audio] In order for the organization to carry out activities relating to medical devices, we will have to fulfill the establishment licensing requirement. The process goes like this: an organization will first need to certified to GDPMD or GDPMDS, the certificate will then be used to apply for licenses for the organization to import products into the country..

[Audio] Since we have already known that it is a mandatory requirement to be certified to GDPMD, now we will look at 'How to Comply with the Requirements'. According to the requirement, an organization will need to establish, document, implement and maintain a Quality Management System ( QMS) in accordance with GDPMD requirement, in which manual, standard operating procedures ( S O P) and other relevant document or records should be in placed to fulfill the requirement..

[Audio] Now we will look at the GDPMD or GDPMDS requirements. You will not be briefed on the full standard but only the main points for your understanding..

[Audio] For EP Plus and Parvus, there are a total of 11 S O Ps to fulfill the requirement. We will now go through it one by one..

[Audio] The first S O P that we have is ' Document Control'. Document here means Manual and S O P. Based on the requirement, the organization shall control the document to ensure the document accuracy, availability, legibility and traceability. When a document has been revised, the control system shall prevent unintended use of the superseded version..

[Audio] The next S O P we have is Records Control, where record means training records, distribution records, product complaint record etc. Record is to provide evidence of conformity to the requirement. The organization shall control for the identification, storage, protection, retrieval, retention time and disposition of records. If you guys are interested to understand more about the S O P that we have, you may access to the GDPMD folder in ShareFile-Common..

[Audio] Moving to the next S O P, we have Medical Device Complaint Handling. Any complaint concerning a defective medical device shall be recorded, investigated, followed through and to take subsequent actions (if is necessary). If the complaint is determined to be an Adverse Event that meets the national reporting criteria, it shall be reported to the country authority per stipulated timelines. EP Plus and Parvus's complaint form can be accessed and downloaded from the complaint folder in ShareFile-Common..

[Audio] We will now move to the next S O P which is Mandatory Problem Reporting, it also means incident or adverse event reporting for a medical device. If an incident meets the reporting criteria, then it shall be reported to the country authority. The Reporting Criteria are: A serious threat the public health; Death or serious deterioration in the state of health of a patient or other person; No death or serious injury occurred but the event might lead to death or serious injury of a patient, user or other persons if the event recurs (near incident / near adverse event); Failure of device / device is the contributing factor to the event..

[Audio] Next is on Field Safety Corrective Action ( FSCA) S O P. This shall only be initiated by the product owner, either the manufacturer or the supplier of the product. For EP Plus and Parvus, we are not the product owner, hence we will only report a FSCA to the country authority when we receive such instruction from our principal..

[Audio] The next S O P that is GDPMD related is Handling of Non-Conformance Medical Devices. Non-conforming medical devices also includes returned medical devices. Whenever a medical device that does not conform to the essential principles of safety and performance as stipulated in guideline or legislations, it shall be segregated from saleable stock to prevent unintended delivery and use until a decision has been determined..

[Audio] Now we move to Disposal of Medical Devices S O P. The organization shall dispose medical devices that no longer meet specification. If the medical device have not been immediately sent for disposal, they shall be kept in a clearly segregated, safe and secured area and identified in accordance with regulatory requirements and any other applicable statutory requirement to avoid mixing up with other medical devices..

[Audio] Moving to the Recall S O P, the organization shall effectively and promptly recall medical devices known or suspected to be defective or counterfeit. The Manufacturer or Authorized Representative shall be informed in the event of a recall & Report it to the country authority..

[Audio] Next, we move to Internal Audit S O P. An internal audit shall be conducted in a yearly basis to monitor, ensure and maintain the continued suitability and effectiveness of the quality management system with the requirement of GDPMD or GDPMDS. Timely action should be taken to correct or eliminate detected nonconformities and their causes without undue delay..