In our earlier post, we discussed the step by step to product classification of in vitro diagnostic (IVD) devices in the United States and Singapore. If you have missed that out the last time, please click on the link above for the article!
This time, we will discuss about product classification for your general medical devices instead. In some countries, product classification principles are standardised across both IVDs and general medical devices but not for some. One good example is the U.S. FDA. The way to search for the regulation and product code leading to product classification of your IVD or general medical device at the U.S. FDA website is the same.
How about those countries, which have product classification routes designed differently for the two main categories of medical devices such as Singapore? Today, we shall discuss about the classification of a general medical device!
GMD classification in Singapore
Singapore, in 2010, is the first country in ASEAN to adopt the Global Harmonization Task Force (GHTF) principles and guidelines for the regulation of medical devices.
The ASEAN Medical Device Directive (AMDD), which is also aligned to GHTF guidelines, was later developed. It establishes a uniform system for medical device registration across all 10 ASEAN Member States. It is expected to result in a more predictable and consistent path to market in Southeast Asia for foreign manufacturers.
The AMDD was agreed to be enforced by January 2015. However, it is yet to be fully implemented as the Member States are adjusting their rules and regulations to be aligned with the AMDD.
Therefore, current medical device regulatory systems in Singapore will provide a good indication of what the overall ASEAN framework will look like.
In Singapore, medical devices are regulated by the Health Sciences Authority (HSA). To be specific, it is the Medical Device Branch (under the Health Product Regulation Group) that regulates the medical devices placed on the Singapore market. The regulatory controls include pre-market assessment, manufacturing controls and post-market surveillance to ensure medical devices available in Singapore are of an acceptable standard in accordance to the Health Products Act and Health Products (Medical Devices) Regulations.
For all stakeholders dealing with medical devices, HSA has also included a series of regulatory guidances for your understanding of the controls. You are able to download these documents from the website.
In the case of product classification for a general medical device, you will need to refer to GN-13-R1.1 Guidance on the Risk Classification of General Medical Devices.
HSA has also developed a classification tool, which lays out a series of questions where you would need to answer “Yes” or “No” and it will help you to identify your product’s risk classification. Do remember to run your product through this classification tool!
Identical to IVDs, general medical devices are classified into four classes, Class A, B, C and D, based on the risk level.
1. Determination of product risk classification using the rules based system
Rules-based system is used to determine the classification of your general medical device. The system consists of a total of sixteen rules. All rules should be taken into consideration in order to establish your product classification.
They are broadly categorised into:
- Additional rules
For each of the category, there are certain rules that apply. They are derived from the following considerations:
- the intended purpose and the indication of use of the GMD,
- the technical/scientific/medical expertise of the intended user,
- a number of factors (the duration of medical device contact with the body, the degree of invasiveness, whether the medical device delivers medicinal products or energy to the patient, whether they are intended to have a biological effect on the patient and local versus systemic effects)
For the purpose of our walk-through, let’s take an electrocardiogram (ECG) as an example:
Intended use - The XYZ ECG is intended to acquire, analyse, display and record ECG signals from surface electrodes by trained operators in a hospital or equivalent facility. The XYZ ECG is not designed to provide alarms for arrhythmia detection.
Firstly, since an ECG requires a power source to operate, it is considered an active medical device. This will help us to narrow down the options to between Rule 9 and Rule 12.
As stated in the intended use, the information is acquired, analysed and recorded on a display. In an actual use case, this information aids the physician in his/her diagnosis of the patient’s cardiovascular status. In this instance, it falls into Rule 10(i) as a Class B device, where it is intended to diagnose/monitor the physiological condition of the heart. It is neither a Rule 10(i) Class A unless it is a device used for illumination (eg, lighting) nor a Class C device because it is not used in a situation where the device is intended to diagnose patient in an immediate danger. This is how you can start out to identify the most correct classification for your medical device.
Finally, you can verify your identification with the result from the HSA risk classification tool to give you that good sense to move forward!
2. Determining the path to market
After knowing the classification of your general medical device, you are now ready to determine the “path” to get your product registered with HSA. For more information and guidance regarding product registration, please refer to the following document - GN-15-R6.1 Guidance On Medical Device Product Registration.
For companies working on product development, it is important to identify your product intended use and classification, as well as getting up a regulatory strategy in your early stages of design. Concurrently, it is also critical to establish a lean, yet robust quality system so to successfully bring your technology to product commercialisation. Good luck with your venture!
Interested to setup and implement a QMS for your company? Contact us now for more information, including a 30-minute complementary demonstration on how an eQMS platform can help you achieve better compliance and get to market faster!