The Health Sciences Authority (HSA), regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the change notification requirements for registered medical devices. The document is intended to provide additional clarifications regarding the interpretation of the applicable regulatory requirements, and also recommendations to be followed by the parties involved. At the same time, provisions of the guidance are non-binding, so in case of any discrepancies with provisions of the underlying legislation, the latter should prevail. The authority also reserves the right to make changes to the guidance from time to time, should it be reasonably necessary to reflect the respective changes to the regulatory framework. It is also stated that in case of any doubts, professional advice should be obtained before taking action.
The authority acknowledges that medical devices could be subject to changes during their life cycle. By the virtue of the present guidance, the HSA intends to describe the approach to be followed by the parties responsible for medical devices concerning the changes implemented after the product has been approved for marketing and use and made available to customers. The Health Products (Medical Devices) Regulations 2010 prescribe that the registration holders are obliged to submit change notifications to the authority concerning the products registered in the Singapore Medical Device Register (SMDR), a country’s register of healthcare products.
The authority also reminds us that under the general rule, all medical devices could be divided into 4 classes depending on the risks associated thereto. The applicable classification system is described in detail in the respective guidance document issued by the HSA. According to the document, these guidelines to change notification are based on the principles of safety, quality, and efficacy of medical devices supplied ; while changes to a medical device can affect its safety, quality, or efficacy and must be approved before the modified device being supplied unless otherwise indicated.
The scope of the present guidance covers any medical devices subject to registration in the national register of healthcare products. In particular, the document outlines the key points to be considered by medical device manufacturers and other parties involved in operations with medical devices when determining the regulatory status of changes and deciding on steps to be taken to comply with the change notification requirements. At the same time, the authority additionally emphasizes that the scope of the guidance and recommendations provided therein does not cover all the situations that may occur. Hence, the particular approach to be followed should be determined on a case-by-case basis depending on the nature of the device in question, its characteristics, and features, and also the risks associated thereto. Moreover, the registration holders are also encouraged to contact the authority to obtain additional clarification.
The authority also states that the scope of the guidance covers all the types of changes medical devices could be subject to including, inter alia, the changes to labeling resulting from an Adverse Event (AE) that meets reporting criteria, or an ongoing Field Safety Corrective Action (FSCA).