China’s medical device market is enormous. The medical device industry makes up more than $96 billion in healthcare spending, and that number has been growing at a more than 20% pace for several years.
For medical device producers, that presents an opportunity for expansion and transformation. In this article, we look at some of the ways in which China is changing its policies around medical device production and how that can benefit your company.
Prolonged Certification Time
Until recently, medical device producers who wanted to enter the Chinese market had a problem. If they wanted to move production of a specific device to a contract manufacturer in China, the producer would have to wait years for the locally manufactured devices to be approved for sale within China.
Limiting Intellectual Property Laws
At the same time, contract manufacturers were hobbled in what they could offer multinational device producers. Prior to registration, intellectual property laws prevented local contract manufacturers from working with multinational companies from producing fully finished devices for sale inside China.
Limited by Jurisdiction
Prior to the recent groundbreaking regulatory changes, devices being produced in China were limited to be marketed strictly in the province of which it was manufactured. The new regulation lifted this limitation as well. Once approved, a medical device can be marketed throughout the entire country.
A New Push For Local Medical Device Production
In 2019 China’s National Medical Products Administration (NMPA) announced new regulations changes were to take effect immediately. The NMPA, China’s equivalent of the US FDA, now has a fast-lane process to approve local manufacturing of medical devices that are already approved for import to China.
Before this change, a device manufacturer had to own the rights to the design of the device it was producing in order to sell that device in China. Effectively, that meant that device designers had to open their own manufacturing facilities in China if they wanted to access the Chinese market This is a massive undertaking for even the largest medical device companies.
Addressing Intellectual Property Concerns
Thanks to the new regulations, device designers can work with a contract manufacturer in China without giving up their intellectual property. This revision to the regulation removes the obstacles making the decision far easier for a medical device OEM to outsource production and register products for sale within China. It is now more realistic and practical to deliver devices to the burgeoning Chinese market by partnering with the right contract manufacturer in China.
A Complete Medical Device Is Now Possible
Furthermore, under the new system, registered contract manufacturers can supply finished medical devices rather than limiting their process to partial product completion. The net result is that Chinese contract manufacturers can take over the entire supply chain for building and delivering medical devices within China.
The COVID-19 outbreak
Following the COVID-19 outbreak, moving production to a contract manufacturer in China could help producers stay ahead of a potential push towards de-globalization in the medical supply industry.
China’s Advantages For Medical Device Producers
The robust nature of China’s manufacturing supply chain offers sourcing high-quality and cost-effective raw materials for local production. In addition, China boasts competitive labor costs and an excellent record of efficiency among manufacturers. The new regulations offer a unique opportunity for medical device producers to enter or expand their footprint in the Chinese medical market. It’s now easier for multinational medical device producers to shift production to contract manufacturers that already operate in China. These same contract manufacturers, once registered with the NMPA, can then deliver fully finished medical devices and help their partner deliver those devices to the local Chinese market.
The opportunity and sheer scale of the medical device market in China must be considered by every multinational device producer. Medical device producers can take advantage of China’s new regulations and tap into the massive Chinese market by partnering with Quasar. Already a leader in medical device manufacturing in China, is ideally positioned to obtain the required cross-regional licensing.
Contact us today to find out how we can help your company deliver fully approved medical devices to the Chinese market.
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