The medical device industry is undergoing continuous transformation to comply with the ever-changing Regulatory guidelines introduced by global Regulatory authorities to ensure strict controls over device performance and safety. In such a scenario, having a better understanding of the medical devices, Regulatory Affairs, and updated Regulatory information to design and implement a strategy can result in reduced costs, time-to-market, and maximum compliance.

Having said that, the need of the hour is to gain insight into ever-evolving market updates. This article discusses Regulatory information, containing an abstract of Regulatory intelligence services of different medical device markets and how Regulatory intelligence can be managed for medical devices.

United States Food and Drug Administration (US FDA)

FDA’s Center for Device and Radiological Health (CDRH) regulates firms that manufacture, repackage, relabel and import medical devices in the United States. FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug & Cosmetic Act (FD&C Act). The FD&C Act contains provisions, that is, Regulatory requirements, that define the FDA's level of control over these products. To fulfill the provisions of the FD&C Act that apply to medical devices and radiation-emitting products, FDA develops, publishes, and implements regulations. The Federal Register is the official daily publication for rules, proposed rules, notices of Federal agencies and organizations, executive orders, and other presidential documents. Proposed rules are initially published in the Federal Register for public comment and subsequently published in the code of Federal regulations after the rule is final. Most of the FDA's medical device and radiation-emitting product regulations are in Title 21 CFR Parts 800-1299.

European Union Medical Device Regulation (EU MDR)

In the European Union (EU), medical devices must undergo a conformity assessment to demonstrate the legal requirements to ensure devices are safe and perform as intended. They are regulated at the EU Member State level, but the European Medicines Agency (EMA) is involved in the Regulatory process.

The Medical Devices Regulation came into force on May 26, 2021, following a four (04) year transition period. Manufacturers must comply with the regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and Directive 90/385/EEC on active implantable medical devices.

Other Regulatory Medical Device Markets

Latin America (LATAM) promises to be one of the most profitable markets for clients in the medical device industry. In LATAM, Brazil and Mexico are the two (02) major medical device markets, with excellent juncture for growth in other markets such as Peru, Colombia, and Argentina. The Regulatory complexities and differences in approach among member countries are the biggest bottleneck for companies seeking to do business in the region. Each country has its own Regulatory intelligence services, unique registrations, quality, and clinical requirements.

Apart from the above-mentioned markets, other leading markets, such as Australia and Malaysia, have dedicated Regulatory websites for medical devices. Medical devices in Australia are regulated by Therapeutic Goods Administration (TGA). The Medical Devices and In Vitro Diagnostics (IVD) shall be listed in ARTG (Australian Register of Therapeutic Goods) before they are marketed in Australia.

Medical Device Authority (MDA) is a statutory body under the Ministry of Health Malaysia. It is established under the Medical Device Authority Act 2012 (Act 738) to control and regulate medical devices, their industry, and activities and to enforce medical device law under Medical Device Act 2012 (Act 737).

If we shed light on medical device markets such as Japan, China, and South Korea, most of the particulars, either on the website or publicly available, are in the regional language. Therefore, Regulatory Intelligence can be challenging in such markets where information is presented in a regional language.

Managing Regulatory Intelligence (RI) in Medical Devices

From a business perspective, due to the anticipated convolution of various devices, the medical device Industry is the world’s most regulated and most demanding in terms of Regulatory strategy and compliance. When bringing RI into light, Regulatory intelligence collectively comprises three (03) main segments which are followed while performing Regulatory Intelligence activities. Let’s understand how each process works:

  1. Gathering Data: An organization should monitor Regulatory changes and needs to have expertise in them. As far as consolidating relevant Regulatory information is concerned, there are many resources that RI professionals can avail from Websites, Blogs and Professional Newsletters, Competitor Product Analysis, Regulatory E-mails, Professional Networking, Guidance Documents, etc.
  2. Analyzing and Processing: Gathering data is the initial step, and so it becomes evident that this data needs to be filtered out to obtain relevant information as per the purpose. This activity includes taking care of factors like the latest trends and patterns in the Regulatory industry.
  3. Regulatory Strategy: The aim to perform above-mentioned propositions is to produce the most satisfactory and acceptable Regulatory strategy for a company. Individual products have their Regulatory guidelines in different countries. RI professionals having expertise on the subject, develop an action plan to commence Regulatory actions for aimed markets.

In conclusion, Regulatory change is viewed as a key component of an organization’s strategic planning process. To support your company with a single, comprehensive source for global Regulatory information to make faster, more informed decisions, you need an industry expert with a dedicated Regulatory Intelligence discipline. Contact Freyr today for more details.


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