Medical Products & China Manufacturing, 2018

February 26th, 2018

The United States has strict rules for importing medical products and devices from other countries.  Per www.fda.gov, “Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. In order to import medical products and/or devices that emit radiation into the U.S., the product must meet FDA regulatory requirements. FDA does not recognize regulatory approvals from other countries.”

China factories manufacture a wide variety of medical products as well as medically-related items to exacting specifications. Currently, the United States exports more medical equipment to China than is imported from China. However, as part of China’s “Made in China 2025” initiative, China’s high-tech factories are working hard to bring their manufacturing in the most technical areas of medical equipment up to world-class standards, while offering many more products in the United States. Many medical products produced through China manufacturing have found a large following in the United States. Moreover, many of these medically-related items manufactured in China successfully meet the exacting standards of our Food & Drug Administration, and are used throughout the US medical industry.

ITI Manufacturing’s clients have medical products such as wound care kits, cold lasers, and timers designed to be used by busy nursing staffs to keep care schedules on track on hospital floors, as well as recovery couches. These are just a few of the medically-related items produced in China. These items, and many others, with the right certification testing, often required to be manufactured in factories certified ISO 13485, are sold and successfully deployed and distributed here in the United States.

Outsourcing Helps Control Healthcare Costs

Despite what has happened, is happening, or will happen politically in our country relating to healthcare, the need for reducing healthcare costs remains a central focal point. Reasonably priced healthcare is the goal on both sides of the political aisle. The reality is the cost to produce many healthcare products in China is much lower than it is domestically. Will that always be the case?  Who knows. However, the current bottom line is that it’s just the way it is, and will perhaps remain this way in the foreseeable future.

What About Quality?

It’s a simple equation: Quality is dependent upon the design specifications of the product being manufactured, the ability of the factory to manufacture the item(s) based on those specifications, and the diligence and tenacity of the testing/inspecting personnel to ensure those specifications have been met and are maintained.  If the original specifications don’t meet the level of quality needed to qualify, a medical item for use under FDA standards will not be allowed to be sold here. Recent statistics show China has a greater number of FDA-registered Class II and Class III medical product and device manufacturing facilities than any other country outside of the United States. Quality of the products produced via China manufacturing is high.  The United States maintains FDA offices within China to ensure that products are manufactured to the proper specifications. The number of China-based FDA offices increase annually.

What is China Capable of Producing?

Currently, China factories produce medical items like gloves and gowns, as well as specialized medical products like imaging, anesthesia, and dialysis equipment. Sophisticated medical equipment is manufactured on a regular basis in China, and then exported to clients across the globe. China’s high-tech medical-focused factories are successful because the environment in these companies demands strict quality control, using only highly trained and dedicated personnel adhering to a strict code of professionalism.

Manufacturing facilities in China are strenuously regulated and accommodating to their foreign clients. These organizations work hard to maintain their high level status.

The process, detail, and certification to manufacture medical products and medically-related devices in China, is frankly no less of an effort than manufacturing items for babies or toys that sell through Toys “R” Us.  The strict adherence to material specifications, the ASTM F-963 testing, and the certification routine for toys, is just as strict…if it’s done correctly.

Many companies are hesitant to investigate China manufacturing with their medical products and related items. They are concerned the products will not be up to standards. That is a valid concern. How can a business not be familiar with the way Chinese manufacturing works, the culture behind how the Chinese factory owner and staff think, or how to control and verify the testing and inspecting criteria? Can they be absolutely sure each and every shipment is correct?  Without trusted personnel on the ground in China working hand in hand with the factory personnel, they really can’t.  All they can do is trust…and hope.