The present article provides an overview of the regulatory requirements to be applied for the premises used for the distribution of medical devices. In particular, the article addresses the aspects related to the storage conditions required to ensure medical devices remain intact within the whole period of them being stored before supply to end users or distributors.
Table of Contents
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 Standard Good Distribution Practice for medical devices. The document highlights the key points to be considered by medical device manufacturers, importers, distributors, and other parties involved in operations with medical devices intended to be marketed in the country. In particular, the guidance describes the approach to be applied to ensure the respective regulatory requirements are followed regarding the distribution of medical devices. It is important to mention that provisions of the guidance are non-binding and are not intended to introduce new rules or impose new requirements. Furthermore, the authority reserves the right to make changes thereto, should it be reasonably necessary to reflect the corresponding changes and amendments to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to the premises and facilities used for the distribution of medical devices in Singapore.
Storage and Stock Handling
First of all, the document describes the approach to be applied concerning storage, warehousing, and stock handling. For instance, it is stated that the premises used should have a special receiving area that provides sufficient protection against external factors medical devices could be impacted by in the course of unloading. Such an area should be also separated from the one used for storage.
The main premises used to store medical devices should ensure the devices are secure and protected against unauthorized access, as well as contamination or other external factors that could adversely impact the quality of medical devices stored. Such premises should have the appropriate ventilation and lighting. The authority additionally emphasizes the importance of having separate zones for the devices that for some reason need to be separated (e.g., recalled or returned products). The measures employed by the party responsible for storage should be sufficient to prevent mix-ups.
In terms of the temperature inside the premises the recommendations communicated by the medical device manufacturer should be followed. According to the applicable regulatory requirements, manufacturers are also obliged to indicate specific storage conditions (if any) on the labeling. To ensure the temperature meets the said requirements, the appropriate checks should be conducted regularly. Apart from temperature, humidity should be also measured, as it can impact the quality of medical devices as well. The authority additionally emphasizes that medical devices requiring special storage conditions (i.e. storage conditions of 8C and below) would require cold chain management (to ensure the proper temperature is maintained within the whole period of transportation and storage).
Special storage conditions should also be maintained concerning hazardous, sensitive, or dangerous materials (e.g., radioactive substances). In this regard, the authority encourages the parties involved to check other applicable regulatory requirements.
Cleanliness and Pest Control
As further explained by the HSA, the premises used to store medical devices should be kept clean all the time, while the devices themselves should be placed in a way ensuring the ease of access for cleaning and visual inspection. The party responsible for the premises should take the respective precautions to prevent breakage or contamination of medical devices stored. Furthermore, it is also necessary to take measures to prevent the entry of insects or pests. The entity managing the premises used to store medical devices should also retain the records related to the reports issued by third-party control companies offering the respective services.
Stock Rotation
To ensure traceability of medical devices, the records related to all incoming and outgoing products should be duly kept by the responsible party. These records should contain, inter alia, an indication of a batch/lot/serial number of medical devices allowing for identifying specific items. Moreover, it is also necessary to conduct a stock reconciliation regularly to ensure the records reflect properly the actual (physical) stock. Any discrepancies identified in the course of such reconciliation should be subject to a rigorous assessment.
Apart from this, it is also important to establish continuous monitoring of the expiry of the projected useful life. The authority additionally emphasizes the strict prohibition on the supply of medical devices after the expiry date, while the products near the expiration should not be received. For this purpose, a FEFO (First-Expiry-First-Out) system should be employed. In case the devices have no expiration date, FIFO (First-In-First-Out) system should be used. \
The authority also mentions that it is important to ensure the integrity of medical devices’ labeling and packaging – should any of these elements be damaged, such products should not be supplied. The same applies to the products with broken seals, damaged packaging, or suspected tampering/contamination.
As was mentioned before, an efficient separation should be employed to prevent mix-ups with damaged or expired medical devices – such products should be stored separately and labeled accordingly to make sure they will not be accidentally supplied instead of the regular ones.
In summary, the present HSA guidance outlines the key principles to be followed by the parties involved in the storage of medical devices intended to be marketed and used in the country. The authority explains the approach to be applied concerning specific storage conditions some of the devices may reasonably need, and also describes the measures to be taken to prevent damage caused to medical devices or accidental mix-ups with the ones that should not be supplied due to issues associated thereto.
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