The new article highlights the aspects related to management review, as well as the requirements for personnel, premises, and cleanliness as set forth by the draft regulation on criteria and good methods for distributing medical devices.
The Thai regulatory agency in the sphere of healthcare products has published a draft regulation dedicated to good distribution practices. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered in order to ensure compliance thereto. The authority also reserves the right to make changes to the document, should such changes be reasonably necessary to reflect corresponding changes to the relevant regulations.
The scope of the regulation covers, inter alia, the aspects related to management review. In particular, it is stated that the top management should appoint executive representatives by assigning the appropriate authorities and responsibilities to ensure that the management system implemented complies with the respective criteria and procedures. The system should address properly the aspects related to the identification and correction of deviations, as well as reporting procedures. A management review should be conducted at least once a year in order to ensure the efficiency of the systems implemented.
The document further outlines the scope of aspects to be covered by a management review. According to the regulation, it should include:
- A follow-up on the results of a previous management review;
- Results from internal audits and external assessments (if any);
- Complaints related to medical devices and any feedback from customers;
- Reports on performance according to the management system compliant with the applicable regulatory requirements;
- Monitoring and surveillance activities, including reporting of performance, abnormal operations of medical equipment, or adverse effects that took place, as well as corrective actions taken in order to ensure the safety of patients, including recalls;
- Feedback from manufacturers;
- Other feedback and instructions;
- Status of corrective and preventive actions;
- Changes that may affect the management system;
- Recommendations for improvement.
As further explained by the authority, the results of the management review will include decisions and actions related to corrective and preventive actions taken to ensure the continued safety of medical devices, the overall effectiveness of the management system employed, and also the necessary resources.
Resource Management: Personnel and Cleanliness
The regulation also provides additional clarifications regarding resource management and the approach to be followed by the parties involved. This includes, inter alia, the factors related to personnel and cleanliness.
In terms of personnel, the authority mentions that an entity conducting activities in the sphere of medical devices should determine the qualification and competence requirements for the personnel it needs based on the medical devices and nature of the activities. In order to ensure the efficiency of the procedure, the entity should have sufficient personnel to cover the relevant functions.
For key personnel responsible for both administrative and operational activities within the scope of operations in accordance with the applicable principles and procedures, the relevant requirements in terms of education, training, skills, and experience should be fulfilled. In particular, the entity should:
- Provide training as necessary;
- Assess the effectiveness of the training;
- Keep records of education, training, skills, and experience.
In terms of basic infrastructure, an entity conducting operations in the sphere of medical devices should determine and maintain the necessary basic utilities it reasonably needs to conduct its activities. This includes:
- Buildings, premises, and related facilities;
- Tools, measuring equipment, and testing equipment;
- Supporting services such as transportation, communication, security management, and other software.
The authority additionally emphasizes that it is the sole responsibility of the entity to ensure that the buildings, premises, and equipment used are suitable, safe, and sufficient as required under the applicable regulations and instructions provided by manufacturers for the devices to be properly stored and distributed. The entity should also be responsible for undertaking maintenance activities in accordance with the relevant procedures and keeping a record of maintenance.
The document also covers the aspects related to cleanliness. The authority states that an entity undertaking activities in the sphere of medical devices are obliged to develop and follow the requirements for cleaning the premises, method, and frequency; appoint a responsible person and duly document the actions taken. This includes pest control – the entities should develop and implement a prevention program to prevent damage and contamination with medical equipment, and also keep pest control records.
In summary, the present regulation highlights certain specific aspects to be taken into consideration by the parties involved in the storage, distribution, and importation of medical devices allowed for marketing and use in the country. The document provides additional clarifications regarding the requirements to be followed in terms of qualified personnel, premises, equipment, and cleanliness. Apart from that, the document also describes the approach to be followed in terms of management review to be conducted on a regular basis to ensure the efficiency of the management system implemented.
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