The article describes the regulatory approach to be applied for medical devices with the lowest associated risk.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to Class A medical devices exempted from product registration. The document is indented to assist the dealers involved in operations with such devices in ensuring compliance with the applicable regulatory requirements. For this purpose, the guidance provides additional clarifications regarding the interpretation of the current legislation, as well as recommendations to be considered in this respect. At the same time, the guidance is non-binding in its legal nature and is not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the recommendations contained therein, should it be reasonably necessary to reflect the corresponding changes to the underlying legislation. The HSA also encourages the parties involved in operations with medical devices to request additional case-specific legal advice.
As it was mentioned before, the scope of the present guidance covers Class A medical devices (the ones with the lowest associated risk) that are exempted from product registration. The existing regulatory framework for these products is based on the Health Products Act and Health Products (Medical Devices) Regulations 2010. According to the said regulations, any medical devices intended to be marketed and used in Singapore should undergo registration with HSA, unless they meet the exemption criteria set forth by the regulation.
Under the general rule, all medical devices are to be assigned to one of four risk classes, where Class A is the lowest one, and Class D is the highest respect. The authority also mentions that the aspects related to the classification of general and in vitro diagnostic (IVD) medical devices are addressed in separate guidance documents. As set forth by the applicable legislation, Class A medical devices could be placed on the market without prior registration, which is required only for medical devices assigned to higher classes. At the same time, the authority additionally emphasizes that all medical devices shall only be manufactured, imported, and wholesaled by HSA licensed dealers. It is also important to mention that even though Class A medical devices are not subject to registration, they still should comply with the requirements set forth by the respective Essential Principles for Safety and Performance of Medical Devices and IVD Medical Devices to be allowed for marketing and use in the country, while the parties involved in operations with such devices should ensure the appropriate Quality Management System (QMS) has been duly developed and implemented. Should the device in question be intended to be supplied sterile, the appropriate sterilization procedures should be followed to ensure the necessary level of sterilization as prescribed by the applicable standards. The HSA also states that the establishments undertaking activities with Class A medical devices should fulfill the general requirements for medical device manufacturers, importers, and distributors.
As was mentioned before, the document is intended to assist in interpreting the regulatory requirements Class A medical devices are subject to, even whilst being exempted from registration which is mandatory for all other medical devices. The guidance describes in detail the approach to be applied and outlines the key criteria to be considered. For this purpose, the document provides some examples of Class A medical devices exempted from registrations and highlights the main points the party responsible for a medical device should pay attention to.
Terms and Definitions
To assist the parties involved in interpreting the provisions of the existing regulations, the document provides the definitions of the most important terms and concepts used in the context of Class A medical devices and the regulatory requirements they are subject to. These definitions include, inter alia, the following ones:
- Registrant means the person who applied for and obtained the registration of the health product under the Act;
- A reusable surgical instrument means an instrument intended for surgical use by cutting, drilling, sawing, scratching, clamping, retracting, clipping, or similar procedures, without connection to any active medical device, and which is intended to be reused after appropriate procedures for cleaning or sterilization of the instrument have been carried out;
- Sterile means, in respect of a medical device, a state free of viable microorganisms.
When defining a “medical device”, the guidance refers to the respective provisions of the Act and regulation.
Dealers of Class A Medical Devices: Key Responsibilities
The document further describes the key regulatory responsibilities for dealers of Class A medical devices. As it was mentioned before, even though the said products are not subject to registration with the HSA, the parties dealing with them should hold a valid establishment license and follow the respective regulatory requirements in terms of their duties and obligations set forth by the national legislation. Thus, dealers are required to keep distributions and complaint records, report adverse events (AE) and notify the Authority of Field Safety Corrective Actions (FSCA). The aspects related to adverse events reporting and corrective actions to be taken to ensure the continuous safety of the patients are addressed in the serpent guidance documents issued earlier by the HSA. The devices themselves should comply with any requirements concerning safety, quality, and effectiveness when used for the intended purpose.
Before placing a Class A medical device on the market, the party responsible for it should submit a list of all Class A products it is going to place on the market. The said list should be provided online before the commencement of the actions intended to make the product available to the customers. The information about all Class A medical devices would be uploaded to the respective database which will be publicly available.
In summary, the present HSA guidance highlights the most important aspects to be considered concerning Class A medical devices that are exempted from registration. The document provides an overview of the applicable regulatory requirements and provides recommendations regarding the actions to be taken to ensure compliance thereto.
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