5 Things to Know Before Entering Chinese Medical Device Market

Chinese medical device market according to statistics and economic forecast is the best place to invest because of many interrelated factors described more extensively in our previous post on Chinese Medical Device Market: Opportunities and Challenges.

Before entering this promised land of yearly double digits growth, you need to do your homework though. While you must bear in mind that technical requirements are one things, cultural and language barrier is the other side of the coin. Today we will provide you with the schedule of the most important steps to perform for the fastest and smoothest market entry possible.

1. Do your research (or ask professionals)

Make sure there is a need for your product on the Chinese market. The needs of Chinese consumers and hospitals change fast so you need to observe the trends and decide if your product is competitive enough or fills a niche. Keep in mind that Chinese public hospitals are encouraged to buy local products and they are allowed to purchase Western equipment only if there is no suitable alternative offered by a Chinese producer which means you will mostly like succeed if you offer innovative and high quality products.

It’s a good idea to conduct at least basic research because of the most distinctive functions of your products which are highly appreciated by Western medical staff don’t have to necessarily appeal to their Chinese counterparts. Interviews with local key opinion leaders and potential users might be crucial when considering entering the market. Always opt for recognized and professional research agencies to obtain the most precise and accurate data.

2. Who is who?

Identify the main players. By this we mean not only your direct competitors but government bodies accountable for medical devices registration and certification. It’s especially important as the procedures and overall registration process is said to be more complicated and time consuming than elsewhere.

• Chinese Food and Drug Administration (CFDA) is the most important ministerial-level institution when it comes to starting medical business in China and is responsible for registration of medical devices for the Chinese market, drafting new regulations and policy plans, safety and supervision

• Center for Medical Device Evaluation (CMDE) is responsible for conducting the dossier review of testing samples during the medical device registration process

• General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) is responsible for carrying mandatory safety registration, certification and inspection of certain devices

Make sure to check their websites (CFDA in particular) for new updates and regulations.

3. Familiarize yourself with the registration process

According to CFDA regulations a medical devices “refer to those instruments, equipment, tools, materials and other objects, including the software attached to them, that are designed to be used either independently or in combination on human body. These devices are used for:

1. Prevention, diagnosis, treatment, monitoring or remission of diseases;

2. Diagnosis, treatment, monitoring, remission or compensation of injury or physical disability;

3. Research, replacement or adjustment of anatomical or physiological process;

4. Control of pregnancy.”

Before applying to CFDA you need to specify the class of the product. There are three classes of medical devices graded according to their risk impact from class I consisting of low-risk, low-maintenance and non-electrical devices to class III including high-risk devices usually implanted into the human body or used for life support.

As already mentioned the registration process can be really burdensome and absorbing. The minimal period of time needed to obtain the registration adds up to 14 months and more for advanced devices requiring clinical trials. Approval in the country of origin is required before registration.

4. Develop and design according to the requirements since the very first step

Here at WILDDESIGN which designing origins are deeply rooted in medical design, we know better than anyone else that product development in medical technology has its own laws.

It is very important to correlate your design process with CFDA regulations since the very beginning since the whole process is integrated. For CFDA registration (as well as for FDA or CE) not only development results but also the process itself need to be performed according to the certification requirements. That means that since the first designing step you have to develop and document the design in the “design history file” and the usability process in the „usability engineering file“.

Keep in mind that properly documented process, decent GUI design and usability are the means that bring you closer to obtaining necessary certifications faster, avoiding application rejections and therefore costly delays and rise your chances to meet customers’ expectations.

5. And find a trustworthy and professional distributors and partners!

Cooperating with a reliable and qualified representation agents and distributors. CFDA requires three local agents for a medical device namely:

1. Registration Agent which is the company that registers the product
2. After Sales Agent who is in charge of technical service and support for the medical device product
3. Legal Agent who is responsible for reporting any events regarding the medical device that occur inside or outside China and for handling any arising recall issues as well as other regulatory matters

Although some distributors are entitled to act as the local agents, it is highly recommended to divide these two (legal and business) functions. If the cooperation between you and your distributor/agent turns out to be unsatisfying, it might be very difficult and costly to pull through and find a new one, because your partner had to sign and officially stamp documentation giving up their responsibilities. Because of the size and fragmentation of the Chinese market very few distributors offering full national coverage, you will probably need to find several distributors or establish cooperation with a partner having a wider business network.
You can also set up your own legal structure in China called Wholly Owned Foreign Entity (WOFE) and take care of the whole business by yourself but that’s a whole different story.

Entering Chinese market might seem complicated and steep but once your device pass all required tests and obtain all necessary certifications it’s pretty much over the biggest hump. If your market research and strategy connect well, your company may soon enjoy rewarding growth and business development on this very demanding, yet highly promising, trade market.