Mindset XR Module 10: What are the international regulations for medical devices?

The US Food and Drug Administration (FDA) is the sole regulatory authority in America. There are no competent authorities or notified bodies like the UK and EU (see module 1 for more information on the regulatory bodies in the UK and EU).

FDA defines medical device software (MDSW) as: 

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognised in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them

intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals

There are only three risk classes of device:

1. Low Risk

2. Moderate Risk

3. High Risk

Pre-submissions (Q-sub)

Pre-submissions are highly recommended as you get to ask the FDA questions. Some advantages of pre-submissions to the FDA include:

• Allows you to develop a “human” relationship with the FDA.

• Removes some of the risk elements from your submission.

• You get asked about things you don’t know and confirm things that you think you do know.

• You can get free (non-binding) advice to help drive your development and regulatory strategy.

• Opportunity to gain valuable feedback on your early documentation.

• 30–100 days depending on Q-sub type.

There are four pathways to regulatory clearance under the FDA: 

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     Clinical Decision Support

     These devices do not acquire or process medical signal data, and provide routinely communicated information to healthcare professionals, with options for their review, rather than indicative outputs for them to follow. 

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   • Does not acquire, process or analyse medical images, signals or patterns.

   • Displays, analyses or prints medical information normally communicated between health care professionals.

   • Provides recommendations (information/options) to a HCP rather than provide a specific output or directive.

   • Provides the basis of the recommendations so that the HCP does not rely primarily on any recommendations to make a decision.

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     510(k)

     This is a streamlined review by the FDA based on an argument of substantial equivalence to an already cleared predicate device on the US market that has the same intended use and technological features. This results in FDA clearance. 

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   • Based on a predicate device already cleared through de novo or PMA.

   • This is a short 90 day* application that details your device’s performance and how it compares to a similar
     device that is already on the market.

   • Costs: $22K ($5K for small businesses)

   • Timeline: *90 days of FDA work – but usually takes longer

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     De Novo

     A more stringent review of a novel but low risk device (typically class I or II) when there is no predicate device. This results in FDA granted. 

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   • Low to moderate risk novel devices.

   • FDA will review De Novo requests for devices that are not within a device type that has been classified under
     the criteria at section 513(a)(1) of the FD&C Act. This includes devices that do not fall within any existing
     classification regulation, where the De Novo requester or FDA determines that there is no predicate device.

   • Upon successful review of a de novo submission, the FDA creates a classification for the device, a regulation
     if necessary, and identifies any special controls required for future premarket submissions of substantially
     equivalent devices.

   • Costs: $145K ($36K for small businesses)

   • Timeline: 150+ days

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     PMA

     The most stringent and lengthy process for high risk novel devices (typically class III). This results in FDA approval. 

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   • High risk novel devices (Class III)

   • Process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, and the most stringent of the device marketing applications.

   • Costs: $484K ($121K for small businesses)

   • Timeline: 250 days average

• The Therapeutic Goods Administration (TGA) acts much like the FDA as a sole regulator.  

• Regulatory framework very similar to the EU, though with more stringent review and a tendency to up-class devices. TGA does encourage pre-submissions.

• Costs: QMS $33K, £45K audit

• Timeline: 190 – 225 business days

• Health Canada acts much like the FDA as a sole regulator. 

• Regulatory framework aligned with the EU, but with the addition of Clinical Decision Support exemptions (as per FDA).  

• If you sell or import any class of medical devices in Canada, you must apply for and maintain a Medical Device Establishment Licence (MDEL) for your business and a Medical Device Licence (MDL) per device.

• Costs: MDEL: $5K, MDL Class II licence: $522, Class III licence: $10K (discounts for small businesses).

• Timeline: 190 – 225 business days.

• To access the UAE foreign medical device market, manufacturers must register the manufacturing site and the medical device with the UAE Ministry of Health and Prevention (MOHAP) through the Registration and Drug Control Department (DRCD).  

• The requirements for UAE device registration broadly follow recognised regulations such as the EU and US FDA.  

• There is a simplified registration process for devices which have received approval from recognised country, including Europe, the USA, Australia, Canada or Japan. 

• As with most international markets, foreign manufacturers must appoint a licensed and authorised representative residing within the UAE to act as their Authorised Representative.

• All companies planning to sell a medical device in South Korea must register their product with the Ministry of Food and Drug Safety (MFDS).  

• There are three market authorisation pathways, depending on the device classification.  

• All devices without a substantially equivalent predicate device in South Korea require clinical data review as part of the registration process.   

• Must appoint a local South Korea License Holder (KLH) to act as your Authorised Representative