Manufacturing of overseas medical device in China

Manufacturing of approved or new foreign medical device in China

Tag

Original Equipment Manufacturers, Contract Development and Manufacturing Organization, Contract Manufacturing, Product label manufacturer, Marketing Authorization Holder Policy

1. If you have already medical device approved in China, with valid certificate, use accelerated approval with production transfer to China

otherwise chose option 2

Background

Since the separate of R&D and manufacturing of medical device in two independent parties for local stakeholder is a trend in 2018 in China, in 2020 a notification "Imported medical device products are produced by enterprises in China" (no. 104) firstly stipulated the requirements of manufacturing approved foreign medical device.

Condition to manufacturing foreign medical device:

· It applies only to in China already approved class II and III medical device which are originally manufactured overseas.

· The foreign manufacturer has to establish a foreign-invested enterprise in China.

· The main production process and raw material in Chinese manufacturing site should not be changed compared to original one overseas. A Comparison report on the equivalence of domestic and foreign quality management systems is to submit.

Chinese authority has mentioned that medical device should be produced by foreign-invested enterprises established in China and no entrusted or outsourced production is allowed!

At the final review of "newly" made in China medical device, whom "overseas twin" was approved by NMPA, only parts of former dossiers are necessary as technical documentation to submit. The review process by authority would be extremely accelerated.

In another notification in 2021 “guidance for the review of government procurement of imported products” there is supporting policy that more and more centre procurement preferred made in China medical device.

Scenarios of manufacturing foreign medical device in China

From establishing own legal entity to Chinese manufacturing there are many legal options. We provide a general analysis here.

1

Own legal entity (R&D) and own manufacturing site in China

The typical establishment for foreign manufacturers in China is usually wholly owned foreign entity, WOFE. If you want to play an independent role manufacturing medical device in China, this is longest and safest way. You can keep all intellectual property in own house and have wished compliant similar production work flow to manufacturing:

1.approved medical device and 2. new medical device in China.

2

Own legal entity (R&D) and bought manufacturing site in China

To build up a factory in China conform to Chinese GMP could be a hard fight. It takes longer to find qualified personal, resource, equipment and ultimately the GMP approval by authority. Another option is to acquire an existing manufacturing site with Chinese GMP. So this manufacturing entity is foreign owned to fit the requirements in above guidance. It is still possible to manufacturer new products there too. Foreign manufacturers should have a careful inspection to assure qualify this bought manufacturing site to have very similar manufacturing workflow as previous one overseas.

3

Joint venture and outsourced manufacturing partner

If you have a confidential partner in China, the typical way is to have a joint venture. They can operate in professional way in China.

In this case an outsourced manufacturing of approved foreign medical device is legal.

4

Find a Chinese investor

Maybe you are a small sized company or have limited capital to establish Chinese business. It is no wonder that the Chinese investors are hghly interested in manufacturing unique foreign products with high technology however with own name. There are many legal spaces to cooperate with Chinese investors either in home county of legal manufactures and or in mainland China.

Chinese entity to manufacture foreign approved medical device

Trust our reliable service

Do you want to or are you planning to manufactur medical device in China, either as typical legal manufacturers or original equipment manufacturer, investor or any stakeholders?

We want to discuss with you all options of manufacturing medical device in China from establishing entity, search of production site with Chinese GMP, accelerated approval in local or central authority and guide of Chinese tender later on.

Trust our premium RA/QM expertise and our partnered law office in China.

1

Analysis of status of subject medical device and competitor in China registered or to be registered

2

Deep details of feasibility of manufacturing medical device in China with all options

3

Establishment of an Chinese entity with best advantage

4

Search of production site with Chinese GMP with similar manufacturing work flow to overseas

5

Transfer of device master file of respective medical device to Chinese factory and alpha launch of first series of medical device

6

Accelerated approval of foreign medical device in Chinese authority

7

After approval issue: UDI, adverse event report

8

Tactical procurement in different provinces

Manufacturing of foreign medical device in China.

2. Outsourced manufacturing of new medical device

If you as Original Equipment Manufacturers (OEM) have never entered Chinese market and want to outsource complete contract manufacturing in a Chinese factory, you can chose either Contract Development and Manufacturing Organization (CDMO) or Contract Manufacturing (CM). The first CDMO differs only that you development together with your Chinese partner whereas the second CM focus only on production of medical device.

There are many scenarios after conform production and product approval of new in China marked medical device. The OEM can be legal manufacturer or outsource further the manufacturing partner or Chinese distributor as legal manufacturer. In this case legal manufacturer has full power of attorney of medical device.

Besides legal manufacturers you have to choose Chinese agent if you don’t have Chinese subsidiary. Again you have select and change whoever you want to time to time: manufacturing partner, Chinese distributor, any Product label manufacturer (PLM). Chinese agent has the liaison role of all post market activities between NMPA and legal manufacturer.

Both legal manufacturer and Chinese agent are obligatory contents in Chinese certificate after product approval.

Workflow of contract manufacturing of new medical device

The advantage of option 2 of contract manufacturing is to save production budget by contract manufacturing and to use existing Chinese GMP. The challenge before production is both overseas and Chinese sites understand device history file during R&D and device master file during production.

After production the extract of medical device file namely technical documentation will be submitted in Chinese to related NMPA (for class I and II MD at provincial leval) which undergoes typical process of made in China medical device.