Written by Patrick Froh
Growing in size and global importance, the market in China can’t and shouldn’t be ignored, especially as it relates to medical devices and applications.
In addition to having the world’s second-largest economy, China holds the top spot as the largest exporter of global production1 — a fact that already has many medical OEMs doing business with various companies located in China.
However, what’s becoming increasingly evident is the need for those same medical OEMs to participate in the Chinese market as importers in order to remain competitive. Why? Initiatives like the “Made in China 2025” plan are transforming what traditionally has been a low-cost/low-tech domestic medical market to a major player in the production of high-performance medical devices such as imaging equipment, robotic surgery devices, wearables, and certain consumables.2
The shift should give medical OEMs from around the globe the impetus needed to sell their products in China, but there are hurdles to entering the market. Successfully navigating the complexities can be as difficult as it is important. It also underscores the need to partner with a contract manufacturer that knows the ins-and-outs of the primary regulation, the China Compulsory Certificate (CCC) mark.
How Can Contract Manufacturers Help?
CCC is a safety mark required on the vast majority of products imported, sold, or used in the Chinese market. The mandate appears straightforward on its face, which may be why so many medical OEMs expanding into China are surprised by how complicated the certification process is — and why so many lose time to market.
It’s not uncommon for CCC certification to take upwards of a year to complete, potentially longer if medical OEMs undertake the task on their own. Having an experienced contract manufacturer come alongside to guide the process with a combination of expertise and experience is optimal.
However, that’s not to suggest that the contract manufacturer should be narrowly focused on the many CCC implementation steps, partially because the steps change so frequently To maximize value from the partnership and gain a foothold in the Chinese market, a medical OEM should seek out a contract manufacturer that, ideally, is globally situated with facilities in China and can demonstrate a history of:
- Direct engagement with the China National Certification and Accreditation Administration (CNCA), the governing body for CCC marks, the China Quality Certification Centre (CQC), the certification organization.
- Fluency in and the ability to produce documentation written in the native Chinese language.
- Awareness of and countermeasures to the risk of product pirating (“shanzhai”) in conjunction with required sample submission related to CCC certification.
- Seamless production of the same CCC-marked products at multiple CCC-certified facilities including those located in the U.S.
As the Chinese market pivots to be both exporter and importer, it’s important that medical OEMs incorporate the shift into their business strategy. Doing so requires partnering with experienced contract manufacturers like GMI Solutions to strengthen knowledge, implementation, and competitive positioning. Learn more in The OEM’s Guide to CCC.
SOURCES
1 Sourcify, Everything You Need to Know about Manufacturing in China, Undated
2 Medical Device Network, What to expect from the medical devices market in China - Verdict Medical Devices, February 22, 2018
