Among the most asked questions from medical device makers who are conducting business in China is how the CFDA guarantees that data stays private and safe.
To help ease the concerns, CFDA recently have made a few documents, including the most recent”Confidentiality Provisions of the CFDA and Medical Device Review and Approval.” This draft strengthens a policy issued by Center of Medical Device Evaluation (CMDE) that set up mandatory measures to reinforce privacy of data submitted by medical device makers.
This latest CFDA draft identifies CFDA as the authority in protecting classified data from medical device makers. In particular, the report incorporates clauses that emphasizes that data falling into the class of “State Secrets” shall be protected by the Law of the People’s Republic of China on safeguarding state secrets.
The following summarizes what’s set forth in latest CFDA draft “Confidentiality Provisions of the CFDA and Medical Device Review and Approval:”
Information pertaining to a manufacturing processes, key technical parameters, know-how and trial data submitted by the applicant;
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
Complaints and reports that are generated during the review and approval process.
CFDA has also proposed setting up a system to respond to issues of the exposure of confidential data by CFDA staff.
To further help protect a device maker’s data, the CFDA has also characterized “non-applicable information in the review and approval process” as private.
China Med Device believes this is an important step forward by CFDA to protect confidentiality of business data from medical device makers.
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