Global Regulatory Pulse

Ensuring the Confidentiality of Chinese Medical Device Manufacturers

In Asian Market, Regulatory by Cindy Hu

One of the most frequently asked questions received from medical device manufacturers conducting business in China is related to the topic of confidentiality and how the China Food & Drug Administration (CFDA) ensures that information remains private, particularly throughout the registration process.

To assist with concerns of confidentiality, both the CFDA and the Center of Medical Device Evaluation (CMDE) have created several guidance documents, including the latest draft document from the CFDA, “Confidentiality Provisions of the CFDA and Medical Device Review and Approval,” released in late 2016. This draft further explores a previous formal document released by the CMDE in 2007 that established required measures to strengthen confidentiality surrounding information gathered during the manufacturing registration process.

This most recent draft guidance from the CFDA raises the legislative authority of the CFDA in safeguarding confidential information. Specifically, the document includes language that emphasizes that information falling into the category of “State Secrets” shall be subject to the Law of the People’s Republic of China on Guarding State Secrets. In addition, any organization not abiding by the laws surrounding state secrets is open to the penalty of other Chinese laws and regulations, in addition to the CFDA’s Confidentiality Provisions.

Below, is an outline of the extended and clarified scope of the definition of confidential information set forth in the most recent draft guidance (2016), “Confidentiality Provisions of the CFDA and Medical Device Review and Approval:”

  1. Information pertaining to a manufacturing processes, key technical parameters, know-how and trial data submitted by the applicant;
  2. Information regarding review and approval conclusions not yet issued, in addition to data surrounding procedures, discussion opinions, consultation opinions, and data related to the technical report (none of which are to be disclosed to the public); and
  3. Complaints and reports that are generated during the review and approval process.

It is important to note that the CFDA has also proposed a procedure to investigate and assess any reported issues of the disclosure of confidential information by CFDA staff.

To yet further aid with safeguarding a Chinese manufacturer’s confidentiality, the CFDA has defined non-applicable information in the review and approval process as private, such as data on patented matters and information required to be disclosed by the government. More detailed measures are also defined for the management of the CFDA’s Internal Information System and related departments and personnel.

In spite of the CFDA’s and CMDE’s best efforts to ensure medical device firms’ privacy, there are still some concerns surrounding the issue, especially as it relates to the recent CFDA draft document.

Specifically, Article 9: Confidentiality Management Agreement defines the length of required confidentiality for any personnel leaving the CFDA as three (3) years. Many in industry have recommended, during the comment period, a length of ten (10) years for CFDA staff members maintain confidentiality obligations. There are also concerns related to the increased liability of violating provisions for experts involved in panel meetings or technical reviews, as significant, increased liabilities and punishments are proposed for these types of situations.

However, it is apparent that with the latest CFDA draft, “Confidentiality Provisions of the CFDA and Medical Device Review and Approval,” that the regulatory agency continues to be transparent and dedicated to the country’s objective of ensuring privacy and confidentiality for medical device manufacturers conducting business in China.

Did You Know?
NAMSA has dedicated regulatory experts in China that are ready to discuss your potential medical device development efforts to help identify the most efficient product pathway for your device. NAMSA’s regulatory expertise, coupled with our recently-opened preclinical research laboratory in Shanghai, is providing clients with significant time and cost savings throughout all stages of the development process.

If you’d like to discuss your medical device development project, please contact us at communication@namsa.com. We also invite you to watch the unique, fun video created for our Shanghai lab opening here.

Authors:

Cindy Hu acts as NAMSA's Director of Regulatory Affairs in China.