China FDA signs off on 3-D printed hip implants

The Chinese Food and Drug Administration (CFDA) approved 3-D printed hip implants in China, encouraging innovation amid an increasingly stringent regulatory environment.

As BioSpectrum reports, hip implants fall into the highest regulated group of medical devices in the country. Before the CFDA's recent approval, hip implants were imported from other countries, often resulting in higher prices. 3-D printing technology cleared by the agency could slash costs, the BioSpectrum article notes, as the implants rely on the body's ability to regrow bone tissue and reduce the need for more expensive materials.

The CFDA blessing could mean big things for companies eager to cash in on China's growing device sector. Earlier this year, a consulting firm forecast that China's medical device market would pass Japan's, becoming the world's second largest and bringing in more than $55 billion in 2015. Big names including GE ($GE), Philips ($PHG) and Siemens are already getting in on the action, launching initiatives in the country to bolster their presence.

But China is also calling for more homegrown medical devices, as it attempts to cut down on imports and promote local products. Last year, the country announced that it would roll out new incentives for its hospitals to use Chinese-made medical devices, combating "unreasonable increases" in healthcare costs while lessening the burden for patients, the Chinese health ministry said at the time.

Still, some companies are finding innovative ways to expand in the country despite the strict regulatory atmosphere. In June, 3-D printing outfit Materialise ($MTLS) and Beijing-based Fuwai Hospital teamed up to open a multidisciplinary 3-D printing center. Under the deal, the Belgium-based company will work with Chinese regulators and hospitals to build 3-D printed heart models.

"We appreciate the opportunity to work with a company that has 25 years of experience in medical 3-D printing as they help us navigate opportunities and achieve medical 3-D printing goals in a safe, economical and sustainable way," Dr. Hu Shengshou, the hospital's president, said at the time of the deal.

- read the BioSpectrum story

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