Clara Li

Navigating Medical Device International Regulations

Medical Device International RegulationsBringing medical devices to market in a single country can be a regulatory challenge. The process often becomes much more complex when marketing in multiple countries and navigating medical device international regulations. A comprehensive understanding of current regulations in each country of interest is required as device laws and regulations are constantly changing. If you’re just starting to think of marketing a medical device in a country outside of Canada, Europe, or the United States, here’s what you need to consider:

Medical device classification categories vary from country to country

Classification categories for medical devices in Europe, Australia, and Russia are Class I, IIa, IIb, and III from lowest to highest risk. China and Canada use similar class categories names: Class I, II, and III. However, unlike Canada, China does not have a Class IV category. India’s medical devices categories are Class A, B, C, and D. It’s important to note that it’s not just the class names that are different (e.g., a Class I device in Europe is not always equivalent to a Class A device in India); the device class can differ between countries due to the different classification rules of each country’s regulatory authority. For example, a device may be classified as Class II in Canada, but in China the device class may be III.

There is no “one size fits all” philosophy

Clearance or approval of a device in one country does not guarantee clearance or approval in another. Similarly, the regulatory requirements to obtain marketing approval for a device are different for each country. However, there is evidence that some countries will give market authorization based on approval in other countries. For example, the Therapeutic Goods Administration (TGA) of Australia is more likely to give approval if the same device has been approved in the EU, and the Central Drugs Standard Control Organization (CDSCO) of India is more likely to give approval if the device is already approved in Australia, Canada, Japan, EU, or the US.

Notification or license?

It may be surprising that premarket approval is not required in some countries such as New Zealand. Here, the major requirement for medical devices entering the market is to be notified on the Web Assisted Notification of Devices (WAND) database by the sponsor. Similarly in India, only devices on the List of Notified Medical Devices, which includes devices such as catheters and orthopedic implants, require a license to market. To sell medical devices in most major markets, however, a license in some form is typically required.

Need for in-country clinical data

In some countries, such as those in the EU, medical devices may require a clinical evaluation to demonstrate safety and performance. The clinical data may be collected through existing literature, clinical experience, clinical trials, or a combination of the three. And it must be compiled and regularly maintained in a report. However, not all regulatory authorities will accept clinical data collected through foreign sources (i.e., outside the regulatory authorities’ country). This is especially true for devices that are “new to market” or “high risk” with few predicate devices in that country’s market. In particular, in-country clinical data may be necessary in countries such as Russia, Japan, and China. Although, the China Food and Drug Administration (CFDA) has recently issued a draft guidance on acceptance criteria of clinical data obtained in other countries.

In-country representation

Companies without a physical location in the country of interest typically must appoint a local representative or agent to coordinate the registration of their medical device with the regulatory authority of that country. The representative’s responsibilities can go beyond submitting the application. In some countries, such as South Korea, this representative or agent must also be a licensed importer who must purchase the products, inspect incoming shipments for compliance, assist with customs clearance, and maintain responsibility for the products on the market. Selecting a dependable and experienced representative or agent to represent your interests is key and can make the difference in a successful medical device application.

Other differences to consider

  • Quality System requirements
  • Recognition of standards
  • Inspection practices

A good regulatory strategy is just as important as how medical devices are designed and manufactured. Most medical device companies focus on selling their products in the major markets which includes the EU and US. However, there is also great value in marketing in other jurisdictions around the world. Keep the information above in mind, conduct proper research and communicate with the regulatory authorities in each country of interest to make navigating medical device International regulations smoother.

Clara Li is a  QA/RA Specialist at StarFish Medical in Toronto. She was inspired to write this by a project that required building a cloud based compliance platform for medical devices. Clara welcomes comments and other tip from readers.

Photo credit: © 36441122 Cao Hai



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