Case Studies


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combination device regulations asia

Is There an Pathway for Our Combination Device regulations in Korea, India, Taiwan, and China?

As the demand for quality healthcare in East Asian countries skyrockets, so does the potential for astronomical growth for the pharmaceutical and medical device industries. While jumping into markets in that region can be tempting, it is important to note that registering an innovative product can be a convoluted process in new, and oftentimes under-regulated, healthcare markets. Predicate devices can be hard to come by, which makes for uncertainty regarding the specific approval process for many products. Additionally, new and evolving regulations can make relevant protocols and requirements hard to identify. RegDesk product allows you to see and always be updated with today's combination device regulations. It is in this context that RegDesk's value proposition is most clear. Using a single data point to gain the most current information on the regulations and registration processes of developing markets puts time, money, and product approval at risk. Crowdsourcing the regulatory knowledge ...
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EMA europe

Regulatory Gap Analysis of Centrally Authorized Biologics in the European Union

Introduction A subsidiary of a Fortune 100 company intended to introduce two pharmaceutical products used to catalyze healthy blood clotting after surgery to 18 countries across Europe, some of which are members of the E.U. and some of which are not. The two drugs had already been approved by the European Medicines Agency (EMA) via the centralized procedure, but the company was curious as to whether or not its products would be subject to any additional country-specific requirements. The company hired RegDesk to conduct a gap analysis and identify these potential requisites. Business Challenge After a pharmaceutical drug or medical device is authorized by the EMA, oftentimes there are separate, country-specific regulations that need to be followed before the product can be introduced to each nation's market. Previously, the client had hired a consulting agency to investigate the protocols of each target country. Because the company relied on a single, ...
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taiwan medical device

How Would Changing Our Distributor Impact the Sale of Our Medical Devices in Taiwan?

Working with a distributor in the country of your target market is one of the most effective ways to quickly get your medical device approved by the local regulatory agency. The benefits of choosing a competent and qualified distributor outweigh the risks of developing and maintaining a transnational, or even transcontinental, business relationship; however, sometimes things go awry. What do you do when your distributor fails to meet sales targets quarter after quarter or fails to represent your company in the ways that you want it to? You may feel inclined to cut ties with the distributor and immediately replace it, but the process is almost never that simple. Remediation from a distributor fallout is a common complication for manufacturers in the medical device industry. When a distributor holds exclusive rights to a manufacturer's license, replacing it without disrupting product sales and distribution can seem impossible. This case study examines ...
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PMDA clinical data

Assessment of Why Japan’s PMDA May Request Clinical Trial Data Instead of Clinical Evaluation Data

Introduction A large medical device manufacturer, faced one frustrating challenge while seeking approval for antimicrobial central venous catheters and antimicrobial dressings in Japan. There seemed to be an inconsistency in the Pharmaceuticals and Medical Devices Agency's (PMDA) clinical data requirements; clinical evaluations for the products of some of our client's competitors were deemed sufficient by the agency while clinical data was demanded for the products of others. The company needed a better understanding of which category their products would fall into, so they enlisted RegDesk's expert help. Business Challenge The PMDA's regulatory framework consists of three general routes to approval: "todokede"‚"ninsho"‚ and "shonin." Todokede is the pathway used to evaluate low-risk medical devices; products that fall in this category typically require only a marketing notification. Most medium-risk and some high-risk medical devices are approved via the ninsho process; third-party certification is required of devices in this category. Lastly, the shonin ...
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