İçindekiler

The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a rehberlik belgesi dedicated to the Essential Principles for the safety and performance of medical devices. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, and could be subject to changes, should such changes be reasonably necessary to reflect the appropriate changes to the underlying legislation. 

Essential Principles: Key Points

Under the general rule, an entity performing the activities related to manufacturing medical devices is responsible for ensuring the safety of such products and their proper performance. The present guidance describes in detail the main requirements in the sphere of design and manufacturing – the Essential Principles of Safety and Performance – to be followed by the manufacturer to ensure the device is safe and operates as intended within the whole period of use. As further explained by the HSA, all Essential Principles could be divided into the two main categories:

• General essential principles, that are applicable for any medical devices irrespectively of their type;
• Specific essential principles – the ones that are applicable either only for In Vitro Diagnostic (IVD) medical devices, or only for non-IVD products. 

According to the guidance, all the essential principles could be grouped as follows:

• General requirements;
• Clinical evaluation;
• Chemical, physical and biological properties;
• Sterility, packaging, and microbial contamination;
• Considerations of environment and conditions of use;
• Requirements for active medical devices connected to or equipped with an energy source;
• Medical devices that incorporate software or are standalone software or mobile applications;
• Medical devices with a diagnostic or measuring function;
• Labeling and Instructions for use;
• Protection against electrical, mechanical, and thermal risks;
• Protection against radiation;
• Protection against the risks posed by medical devices intended by-product owner for use by laypersons;
• Medical devices incorporating materials of biological origin. 

It is also stated that the party responsible for a medical device should determine the particular requirements to be applied depending on the type and characteristics of the medical device in question, while such a decision-making process should be duly documented. 

Safety- and Performance-related Standards 

The document further describes the roles of standards in meeting essential principles of safety and performance. For the guidance, a standard stands for a document, established by consensus and approved by a recognized body that provides, for common and repeated use, rules, guidelines, or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context. According to the guidance, there are several types of standards, namely:

• Basic (horizontal) standard – the one that established fundamental concepts and core requirements related to the safety and effectiveness of medical devices. These requirements could be applied to a wide range of medical devices and manufacturing processes. For example, this category includes standards related to the quality management system to be followed when manufacturing medical devices. 
• Group (semi-horizontal) standard – the one that applies to specific groups (families) of similar medical devices, while providing references to the basic ones. This category includes, inter alia, the standards related to sterile medical devices. 
• Product (vertical) standard – the one that outlines device-specific safety- and performance-related requirements, even if it still contains references to the general ones. This category includes the standards for blood glucose meters for self-testing and other separate types of medical devices. 

As further explained by the HSA, depending on the origin, the standards could be divided into national, regional, and international. As of today, there are three main international standardization bodies:

• International Electrotechnical Commission (IEC) for electricity, electronics and related technologies;
• International Telecommunications Union (ITU) for telecommunications and radio communications; 
• International Organization for Standardization (ISO) for nearly all other technical fields, service sectors, management systems, and conformity assessments.

The regional level is represented by
various European standard bodies, such as the European Committee for Standardization (CEN), or the European Committee for Electrotechnical Standardization (CENELEC), as well as the bodies based in other parts of the world. 

The national level is represented by the bodies the scope of activity of which is limited to the specific countries – for instance, the British Standards Institution (BSI), German Institute for Standardization (DIN), or Standards, Productivity and Innovation Board (SPRING Singapore). 

Applicability of Standards 

The HSA also outlines the key points related to the particular way the standards should be applied. According to the guidance, standards could be used to: 

• Set forth the general requirements medical devices should comply with;
• Outline the main aspects related to the safety and effectiveness of medical devices, as well as the ones related to the processes and procedures;
• Ensure compliance of all the devices placed on the market with the respective requirements;
• Ensure the opportunity to combine or substitute medical devices produced by different manufacturers. 

At the same time, it is important to mention that the standards are used voluntarily. Hence, the parties responsible for a medical device are allowed to decide on the particular way to demonstrate compliance with the applicable requirements. According to the guidance, compliance with the Essential Principles could be also demonstrated by the following:

• The industry agreed methods;
• Internal product owner standard operating procedures developed by an individual product owner;
• Other sources describe the current state of technology and practice related to performance, material, design, methods, processes, or practices. 

At the same time, the use of alternative solutions described herein should be agreed with and approved by the authority. 

Teknik döküman 

Medical device manufacturers are also obliged to follow the record-keeping requirements in the part of retaining the documents demonstrating compliance with the applicable Essential Principles or requirements outlined in other sources, even in the case the product in question is not subject to mandatory registration to be allowed for marketing and use in the country (e.g., Class A medical devices). According to the guidance, documentation may include, for example, the standard itself, how it was applied, deviations, test results, and relevant pass/fail criteria when these are not specifically stated in the standard and/or other outputs. 

In summary, the present HSA guidance highlights the most important aspects associated with the Essential Principles and the way they should be followed by medical device manufacturers intended to market their products in Singapore. The document pays special attention to the standards and their applicability. 

kaynaklar:

https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gn-16-r2-guidance-on-essential-principles-for-safety-and-performance-of-medical-devices(18jun-pub).pdf

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