The article provides an overview of the regulatory requirements in the sphere of distribution practices for medical devices.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the application of the country’s good distribution practice for medical devices. The document is intended to provide additional clarifications regarding the existing regulatory framework, as well as recommendations to be taken into consideration by all the parties involved to ensure compliance with the respective regulations. At the same time, provisions of the guidance are non-binding and are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should it be reasonably necessary to reflect the changes to the underlying legislation.
In particular, the present guidance provides additional details regarding the application of the SS620:2016 Singapore Standard for Good Distribution Practice for Medical Devices – Requirements (SS GDPMDS). The document describes the approaches to be followed by the parties involved in terms of the implementation of a quality management system compliant with the requirements set forth by the aforementioned standard. However, as was mentioned before, the present guidance is not intended to make any changes to the standard itself, but only to provide additional clarifications regarding the requirements prescribed by the standard should be followed. The guidance also addresses the aspects related to certification bodies and the Singapore Accreditation Council.
The authority additionally emphasizes that compliance with the guidance itself does not mean compliance with the applicable legislation, hence, the parties involved are solely responsible for identifying the applicable rules and regulations and ensuring compliance thereto.
Under the general rule, the company should develop a quality management system that conforms to the requirements of SS GDPMDS and demonstrate its ability to maintain the quality and integrity of medical devices throughout the supply chain. The aforementioned standard applies to medical device importers, wholesalers, and outsourced service providers undertaking their activities in the country.
Quality Management System
As further explained by the HSA, the quality management system established should be sufficiently robust to meet external and internal considerations such as changes in regulatory requirements, customer feedback, changes to key personnel, facilities, etc. The document also pays special attention to the procedures to be developed and implemented concerning the quality management system – the authority states that their structure and level of detail should be based on the specific needs of the company, as well as additional factors, such as the technologies used, or qualification of the staff involved in operations with medical devices. The said procedures could exist in various forms.
The system should also provide efficient control ensuring the accuracy, availability, legibility, and traceability of documents. Furthermore, the entity operating with medical devices is also obliged to establish a record-keeping system for the records related to compliance with the standard. In case of an electronic record-keeping system is used, such a system should have controls ensuring the integrity of documents contained therein, and also the mechanisms preventing unauthorized access and ensuring tracking changes.
The document further provides several examples of records and indicates the retention period for each of them. The examples described in the document include the following ones:
- Attendance and minutes of management review should be retained for 3 years (in line with the audit cycle and should be available at the point of audit);
- Training records, attendance, and training effectiveness checks should be retained at least for the period of employment;
- Records of receipt should be retained for the projected useful life of the products in question, or for 2 years from the date of supply (whichever is longer), the same approach should be applied to records of installation, commissioning, and the appropriate tests, as well as the servicing activities;
- Records related to the investigation of complaints and actions taken in this respect should be retained for at least 5 years after the expiry of the projected useful life of the product;
- Records related to the internal audits should be retained for at least 3 years.
For the rules described hereinabove, the projected useful life of a product should be determined by the medical device manufacturer responsible for the device.
The types of records that are not explicitly mentioned in the present guidance should be retained for the period to be determined by the entity itself based on the nature of the product in question or the activities performed.
Another important aspect addressed in the guidance relates to management responsibility. In this respect, the authority states that the organization should document job descriptions, including key responsibilities and authorities, within the Quality Management System, e.g., in the Site Master File. It is important to mention that the matters related to the Site Master File are described in detail in the appropriate guidance document issued by the HSA.
As further explained by the FDA, each appointment of the management representative should be duly documented, and the appropriate records should be duly kept. The authority additionally emphasizes the importance of ensuring there is no conflict of interest between the functions related to the quality management system and other functions the management representative shall perform.
The quality management system should be subject to review by the top management of the organization on an annual basis. The records of such review could be kept in any form the organization finds suitable. According to the guidance, records of the management review should include the identity of those taking part in the review, the date(s) of the review, and all the review input and output aspects listed in the SS GDPMDS; this includes a description of any corrective or preventive action to be taken.
In summary, the present HSA guidance highlights the key points related to the approach to be applied by the parties involved in the distribution of medical devices in terms of the quality management system to be implemented. The document also provides additional clarifications regarding the record-keeping requirements and management responsibility.
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