China MAH Policy Changes and The massive Opportunity for Medical Device OEMs

The new MAH or Marketing Authorization Holder Policy has opened up a whole new level of opportunities for medical device companies. On the global front, medical device companies have established their presence in leading economies such as the United States and the United Kingdom. In order to grow further, OEMs must capitalize on the major changes taking place in the Chinese market in allowing high-quality medical devices to be manufactured and marketed without as many restrictions as they experienced prior to the 2019 MAH Policy.

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Why market medical devices in China? 

While low labor cost is one of the advantages, China is a country with a population of 1.4 billion, the medical devices market size, in 2018 was $78.8 billion, which grew to $96.3 billion in 2019. It’s estimated that China’s medical device market growth of 22% (2018-19) could continue over the next few years. In comparison to the United States and the United Kingdom, China ranks number three in the world as far as the size of the medical devices market is concerned. With the new Marketing Authorization Holder Policy, the Chinese market is positioned to grow even more.

Impact of the MAH Policy in China:

Medical Device Manufacturers (MDMs) and Original Equipment Manufacturers (OEMs) have had a hard time gaining access to the vast Chinese market till August 2019. China has had rigorous market entry restrictions and very limited funding for imported medical products. 

With China’s massive market size, Medical device companies regardless of their specialization (in R&D or Manufacturing) had no choice but to establish manufacturing operations in China, in order to sell within the Chinese market. This required immense funding and resources from OEMs. 

Ultimately, even with their own manufacturing set-up based in China, stringent regulations prevented these products from being classified as Chinese products. This restricted their use drastically within healthcare facilities. However, with the advent of the new Marketing Authorization Holder Policy, OEMs and MDMs, are now able to outsource production to a local Manufacturer and sell products as “Made in China” in the local market, under a new registered license.

Your Potential China Strategy:

With the MAH Policy, medical device companies have a number of options available to them that will allow their products to be more accessible to the Chinese market. Here are some of the ways in which OEMs and MDMs can operate effectively under the China MAH policy:

1. OEMs are now free to focus on their core competencies of R&D and New Product Development, while they not only outsource but partner with Contract Manufacturers (CM). Partnering enables CMs to be involved beginning at the product development stage. Choosing a CM that’s held by the same parent holding group serves to avoid duplication of manufacturing efforts. 
2. OEMs could continue their partnerships with China-based CMs in order to register and market their products under MAH to hospitals, as “Made-in-China”. True Partnership enables effective collaborations between researchers, engineers and innovative enterprises, across geographical regions.
3. OEMs from the United States have a trade advantage with China-based CMs to continue marketing products as “Made-in China”. Local production of high-end medical devices, at par with international standards, has been highly anticipated by the Chinese market.
4. For Start-up OEMs, partnering with a Contract Development and Manufacturing Organization (or CDMOs) is the quickest and most profitable way to bring new medical devices to market. The Beijing and Shanghai provinces have allowed the delegation of manufacturing to CDMOs based across the provinces of China.  

The Way Forward

The China MAH policy thus allows for high-quality, complex medical devices to be manufactured by CMs or CDMOs in China, with all existing and new products being registered afresh with the NMPA, under the MAH Policy. 

OEMs that are Non-China-based or China-based, may operate with any of the listed strategies. So choosing to partner with a CM that has end-to-end complex assembly capability and high volume capacity is ideal. To date, Quasar happens to be the only CM located in China, with such capabilities. Armed with the MAH Policy, Quasar is additionally blazing forward with initiatives to partner with Non-China and China-based OEMs, as its local reputation continues to grow. 

While major Medical Device Companies have already begun to grab this massive China advantage, Quasar is perfectly positioned to help more OEMs leverage the same opportunities in the second largest economy in the world.