3 Regulatory Guidelines for Navigating China's Drug Delivery and Medical Device Markets
As the world's second largest medical device market, China offers a significant opportunity for drug delivery companies to expand their global footprint in Asia. For companies familiar with doing business in the U.S., navigating the regulatory pathway of the Chinese Food and Drug Administration can be a challenge. This white paper shares three guidelines to help facilitate a deeper understanding of the CFDA's regulations.
Critical Considerations for High Viscosity/High Volume Drug Delivery Devices
High viscosity and/or high volume drugs require special attention from device developers, particularly when associated with biologics. As the use of biologics continues to increase, early involvement between the drug manufacturers, device designers and device manufacturers is critical to the development of the most efficient overall strategy of drug/device life cycle.
The First Step To Navigating Your Combination Product's Regulatory Pathway: Defining the Primary Mode of Action (PMOA)
As the drug-device combination product market continues to grow at a rapid pace, it is important for companies to avoid unnecessary delays and gain speed to market with 'right the first time' regulatory submissions of their combination product. The first step is determining a product's regulatory pathway.
Bringing Metal Parts to Life with Complex Geometry and Precision Tolerances
Metal injection molding is an effective way to produce complex and precision-shaped parts from a variety of materials, in low to extremely high volume capabilities, as well as effectively and with significantly reduced lead times.
How Safe Is Your Battery?
The increase in portable electronic devices, has also increased the demand for the batteries that power them. However, batteries are susceptible to failure, particularly when physically damaged or breached, potentially causing a fire, explosion, or hazardous leak. Phillips-Medisize's impact-resistant battery technology has the potential to help minimize harm to property and lives, while enhancing the safety of devices that run on rechargeable lithium-ion batteries.
6 Guidelines To Follow When Developing Combination Products
Development of a combination product comes with significant patient benefits, but that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities. This white paper includes 6 guidelines to improve the odds of first-time regulatory approval, thereby enabling speed to market.