What we are about to share with you is a guide to medical device regulatory classification.
In this guide, we will provide you the step-by-step approach to how your in vitro diagnostic medical device (IVD) will be classified in the United States and Singapore.
The information provided is intended to help you understand the purpose of medical device regulatory classification and what is required for your IVD medical device.
It is not a comprehensive guide to regulatory submissions, yet should give you some basic guidance and direction on identifying your IVD’s pathway to market.
Why does regulatory classification even matter?
Knowing how your medical device is classified matters for the following reasons:
- Product classification will determine what you have to do BEFORE you can sell your product.
- Product classification will help you establish what is required during product development, design controls and risk management.
- Product classification is an important component in determining how much it will cost, as well as the proposed timeline to bring your medical device to market.
The basis of regulatory classification
Basically, every medical device is regulated in some way by regulatory agencies, such as the US Food & Drug Administration (FDA) and Singapore’s Health Sciences Authority (HSA). These regulatory agencies have defined a set of rules and regulations (or “laws”) regarding medical devices.
The rules that apply to your medical device depend on how your product is classified by the regulatory agencies. Each regulatory agency has defined several different classifications for medical devices.
The classifications are, for the most part or as a general rule, related to the perceived risk of the product type.
IVD Medical Device Classification in U.S
In the U.S., medical devices are regulated by the FDA. The specific branch within FDA is Center for Devices & Radiological Health (CDRH). The mission of CDRH is to protect and promote public health. In other words, ensure medical devices are safe.
Medical devices (including IVDs) are either Class I, Class II, or Class III. All medical devices are classified using the same guidelines. The FDA CDRH classification is based primarily on the risk that the medical device poses. The type of controls required is dependent on your product’s classification.
Classification is directly related to intended use and indications for use.
Intended use is the general purpose of the medical device or its function (what you “claim” the medical device does).
Indications for use describes the disease or condition the medical device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population.
1. Finding the Applicable FDA Regulations for Your Medical Device
Once you define intended use and indications for use of your IVD, you need to find the possible regulations and product codes. Tracking down regulatory classification for your product via FDA takes a little bit of time and perseverance. FDA has established several general categories based on the medical specialty: CFR 21 Parts 862 to 892.
When you have identified the possible category, click on the regulation number. This will lead you to another page where you will see the sub-categories, bringing you nearer to your product classification.
For the purpose of our walk-through, let’s take a Human chorionic gonadotropin (HCG) pregnancy test kit as an example.
Below is a partial view of the options for " 862 Clinical Chemistry and Clinical Toxicology Devices".
When you find a regulation that appears to be a possible fit, you can click on the link and get more details to make a determination.
For example, if I think my device fits in "862.1155 Human chorionic gonadotropin (HCG) test system" , I will click on the link and see the following information:
The details provided me an idea if my IVD’s intended use and indications for use is aligned with this specific regulation.
I also found the FDA device classification.
In this example, I learned that my IVD is classified as Class II , which means I will need to submit a 510(k) application to FDA prior to getting market clearance.
2. Find the Applicable Product Codes
Finding the applicable regulation for your medical device and classification is the first part. Now you need to find the applicable product codes and here’s how:
Go to the FDA Product Classification Database and type in the regulations number you found. If you find more than one possibility, then you will need to repeat this process for each.
When you click “search”, you will get a list of possible product codes.
You can then review each individual code to determine the best option for your IVD by clicking on each code.
3. Determining Your FDA Path to Market
Knowing the applicable regulation and product code (as described above) is necessary for you to determine the classification of your medical device. Once you have this information, you will now be able to determine the “path” to get your product registered with FDA.
Here are the options:
- Class I (low to moderate risk): general controls
- Class II (moderate to high risk): general controls and special controls
- Class III (high risk): general controls and Premarket Approval (PMA)
If you find your IVD is “exempt,” then only general controls apply and no formal FDA submission is required. You do, however, need to register your establishment with FDA and then list your medical devices.
If you find your IVD requiring special controls, this means you will have to prepare a 510(k) submission to FDA and receive clearance before going to market, on top of registering your establishment and listing your medical devices.
If you find your IVD requiring premarket approval, this means you will have to follow the FDA PMA process to receive approval before going to market.
IVD Medical Device 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 still in discussion on how they would align with the AMDD.
Nevertheless, 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 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 their website.
In the case of product classification for IVDs, you will need to refer to GN-14- R1.1 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices.
You can also visit HSA Medical Device Risk Classification tool to help you identify the risk classification of your IVDs.
IVD medical devices are classified into four classes, based on the individual risk and public health risk level.
1. Determination of product risk classification using the rules based system
Rules-based system is used to determine which class your IVD falls into. The system consists of a total of seven rules. All rules should be taken into consideration in order to establish your product classification.
The rules are derived from the following considerations:
- the intended purpose and the indication of use of the IVD,
- the technical/scientific/medical expertise of the intended user,
- the importance of the information to the diagnosis,
- the impact of the result (true or false) to the individual and/or to public health.
Similarly, we will use the example of the Human chorionic gonadotropin (HCG) pregnancy test kit to walk-through this exercise:
After reviewing through the seven rules, a pregnancy test kit should fall into Rule 4:
Since a pregnancy test kit requires follow-up with appropriate laboratory test, it will be classified as a Class B IVD.
2. Determining the path to market
After knowing the classification of your IVD, you are now able to determine the “path” to get your product registered with HSA. For more information regarding the requirements needed to have your IVD registered with HSA, please refer to the following guidance document - GN-15-R6.1 Guidance On Medical Device Product Registration.
In summary, you should have realised that the product classification principles are quite different when we compare the US and Singapore, even though the product is the same. Other key markets such as Europe, Australia, Japan and China have different regulatory framework too. Thus, it is important to identify your target markets in the earlier stages of your product development phases. This ensures that your product is developed with a “go-to-market” strategy, which includes the respective countries’ regulatory requirements.
We will continue to discuss about product classification of medical devices for other markets in our subsequent blogs. Subscribe to us if you would like to hear more!
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This blog is written in collaboration with greenlight.guru.