Key Regulatory Issues for Establishing a New Green Field Device Factory in China

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By Ames Gross, President and Founder of Pacific Bridge Medical

This blog post was also published on MedTech Intelligence.

Over the last few months, a number of medical device companies have contacted me about setting up a new green field device operation in China. Please keep in mind that when launching a new medical device manufacturing site in China, companies must obtain a number of basic regulatory approvals. These approvals include:

  • Business License
  • Product Notification Record (for Class I devices) or Product Registration Certificate (for Class II and III devices)
  • Medical Device Manufacturing License (with GMP Inspection)

These licenses must be submitted sequentially. There are also other approvals that may be required depending on your particular manufacturing operation. For example, you may be required to apply for Foreign Investment Approval if foreign investment is involved. Depending on your factory’s design and location, local governments may also require permits related to environmental damage or fire safety issues.

Applying for a business license is the first step when setting up a legal entity in China to manufacture medical device products. Companies can obtain a business license from the Local Administration Bureau for Industry and Commerce. Depending on the type of device that you are planning to manufacture, you will have to register your product with the local, provincial, or national China Food and Drug Administration (CFDA).

To apply for a Medical Device Manufacturing License, please note that Class I Medical Device Licenses are issued by the local FDA office and no longer require registration approval as they did previously. The manufacturer should bring the appropriate documents to the local FDA office and, if the documents are accepted, the Manufacturing License will be issued within a few weeks. In order to receive a Class I Manufacturing License, companies must submit the following documents:

  • Copy of Class I Device Product Notification Record
  • Copy of Business License and Organization Code Certificate
  • ID copy, CV, and support documents for people involved in production, quality management, and technical departments
  • ID copy of the facility’s legal representative and the facility manager
  • CV of Quality Control staff and production departments
  • Manufacturing Site rent/purchasing documents
  • Environmental assessment documents/Equipment Approval Documents
  • Production flowchart
  • Authorization letter to the person who submitted the filing
  • List of major production and quality analysis equipment
  • Quality manual and SOP files

Class II and III device licenses are issued by the provincial FDA office. The requirements for Class II and Class III devices are quite similar to the requirements for Class I, but companies must obtain the Device Product Registration Certificates before applying for the Manufacturing License.

Class I, II, and III manufacturing licenses must be renewed every five years. For Class I devices, the renewal process is similar to the initial application procedure. If the manufacturer brings the appropriate documents to the local FDA office, the notification acceptance record will be updated within a few weeks. For Class II and Class III devices, the renewal manufacturing application must be submitted at least six months before the expiration date of the initial approval. The documents and timeline are the same as the initial application process.

All medical device manufacturers must also receive a proper GMP inspection. While the China FDA does not issue a GMP certificate, manufacturers must undergo official GMP compliance and inspection in order to receive their Medical Device Manufacturing License. For Class II and III devices, on-site GMP inspection is required before the local FDA will issue a manufacturing license.

Please carefully review the above information when setting up a new device factory from scratch. In my experience, companies that do not follow these steps or submit the right documents face long, frustrating delays. Also, do not forget the importance of relationships in China. Getting to know the local government decision makers (city, provincial, etc.) and local FDA officers may turn out to be crucial for success.