Throughout August 2014, the China Food and Drug Administration (CFDA or the Agency) made significant process in issuing finalized rules and guidances to implement the revisions to its core medical device regulation, the Medical Device Supervision and Administration Regulation (MDR).  The State Council revised the MDR in March, and it went into effect on June 1, 2014.  The following is a brief introduction to some of the more significant finalized rules and guidances, as well as additional proposed rules and guidances that CFDA put out for public comment.

Final Rules:  CFDA finalized five major implementing rules, all of which go into effect on October 1, 2014.

• It finalized two revised “registration regulations,” one for in vitro diagnostics and the other for all other medical devices.  These registration regulations govern the entire market approval process from research and development through CFDA’s issuance of the appropriate registration, or in the case of Class I devices, notification documentation.  They also govern the procedures for amending and renewing that approval documentation.

• CFDA also finalized two sets of rules governing the manufacture (including contract manufacturing) and distribution of medical devices.  These rules serve as the starting point for understanding the requirements for obtaining the necessary manufacturing license for a Class II or Class III device or the necessary distribution license for a Class III device.  These rules are separate from China’s medical device Good Manufacturing Practices and its proposed medical device Good Supply Practices, which are both the subject of ongoing rulemakings.

• CFDA finalized new rules on medical device labeling and package inserts.  These new labeling rules set forth a more detailed list of required items for labeling.

Notices:  CFDA has issued several notices to clarify the applicability of the new implementing regulations.  One notice, applicable to both registration regulations, advises stakeholders how implementing regulations will apply, for example, to active licenses, license applications that are currently pending, and planned clinical trials.  Another notice is to manage issues related to new impending requirements for manufacturing and distribution enterprises.  CFDA issued similar transitional notices related to the MDR itself (see our entry, here) and new provisions on Class I devices (see our entry, here) in May 2014.    The new notices provide significant information about the effective dates and the operation of new requirements.

Catalogues:  CFDA also issued three finalized catalogues related to the two sets of registration regulations.  The first two catalogues, respectively, set forth a list of Class II and Class III devices that will enjoy exemptions from the clinical trial requirements.  The third catalogue is a list of high risk Class III devices for which CFDA will now require pre-approval for clinical trials.

New Proposals:  CFDA released several proposed rules and guidances in August, including:

• Proposed rules on the naming of medical devices, with a comment period that closed on August 30, 2014.

• Proposed revisions to medical device good manufacturing practices;  the comment period closed on August 15, 2014.

• Proposed guidance on clinical trials for IVDs, which sets forth new requirements on the number of samples in different trials and new standards for ethical issues, such as informed consent and ethics committee review.

• Proposed guidance for drafting package inserts for IVDs.  The comment periods for both IVD guidances closed on August 31, 2014.

• Proposed guidance governing clinical evaluations for non-IVD devices.  The comment period closes on September 8, 2014.  This important proposed guidance provides insight into the how to utilize the above catalogues to determine whether a device meets the exemptions to the clinical trial requirement, as well as guidance on gathering and evaluating clinical data.

CFDA has also released some of the new forms and templates associated with applications for licensure of devices and device enterprises, but stakeholders should continue to monitor for more in the coming month.

We encourage medical device companies to take advantage of opportunities to comment and other opportunities to discuss concerns with CFDA.  For example, the Agency is planning to hold a roundtable on medical device regulation and is accepting applications for attendance until September 14, 2014.  Medical device manufacturing and distribution companies that do not have a history of legal violations, have been in business for more than three years, are familiar with relevant laws and regulations, and are able to offer concrete suggestions on medical device regulatory enforcement may apply to have representatives attend this meeting.  We can provide further information about applying for the roundtable or commenting on the proposals.