Fabricación en China de dispositivos médicos extranjeros, tanto aprobados como nuevos.
Etiqueta
Fabricantes de equipos originales, Organización de desarrollo y fabricación por contrato, Fabricación por contrato, Fabricante de etiquetas de productos, Política del titular de la autorización de comercialización
1. If you have already medical device approved in China, with valid certificate, use accelerated approval with production transfer to China
Fondo
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.
Condiciones para la fabricación de dispositivos médicos extranjeros:
· Se aplica únicamente a dispositivos médicos de clase II y III ya aprobados en China, que se fabrican originalmente en el extranjero.
· The foreign manufacturer has to establish a foreign-invested enterprise in China.
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.
En otra notificación de 2021, titulada "Guía para la revisión de las compras gubernamentales de productos importados", se incluye una política de apoyo que indica que cada vez más organismos centrales prefieren los dispositivos médicos fabricados en China.
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
Entidad jurídica propia (I D) y planta de fabricación propia en 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
Entidad jurídica propia (I D) y planta de fabricación adquirida en 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
Si tienes un socio de confianza en China, lo habitual es establecer una empresa conjunta. De esta forma, podrán operar de manera profesional en China.
En este caso, la fabricación subcontratada de un dispositivo médico extranjero aprobado es legal.
4
Encuentra un inversor chino
Quizás su empresa sea pequeña o cuente con capital limitado para establecer un negocio en China. No es de extrañar que los inversores chinos estén muy interesados en fabricar productos extranjeros únicos con alta tecnología, pero con su propia marca. Existen numerosos espacios legales para colaborar con inversores chinos, tanto en el país de origen de los fabricantes legales como en China continental.
Confíe en nuestro servicio confiable.
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.
2. Fabricación subcontratada de nuevos dispositivos médicos.
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.
Flujo de trabajo de la fabricación por contrato de nuevos dispositivos médicos
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.
Tras la producción, el extracto del archivo del dispositivo médico, es decir, la documentación técnica, se presentará en chino a la NMPA correspondiente (para dispositivos médicos de clase I y II a nivel provincial), que sigue el proceso típico de los dispositivos médicos fabricados en China.
