On 7 March 2014, the PRC’s State Council published its revised Regulation on Supervision and Administration of Medical Devices (“2014 Revision”). The 2014 Revision comes into effect 1 June 2014. The 2014 Revision is the first major overhaul of the regulation of medical devices in the PRC since 2000.

The main changes in the 2014 Revision include:

1. "Risk-Rating" matrix

The 2014 Revision defines a "Development vs Production vs Distribution" matrix for each of Class I, II and III medical devices, and then assigns a risk-rating ("Risk-Rating") to each "cell" within this matrix.  For example, the matrix defines the "Class I – Distribution" cell as "Low Risk".  Then, using these Risk-Ratings, the 2014 Revision prescribes how each Risk-Rated activity is to be regulated (in terms of filings, registrations, approvals, self-audits, external audits, quality-control, record-keeping, physical storage/transport and associated penalties).

2. Random regulator audits and product defects/recall

The 2014 Revision defines a "Development vs Production vs Distribution" matrix for each of Class I, II and III medical devices, and then assigns a risk-rating ("Risk-Rating") to each "cell" within this matrix.  For example, the matrix defines the "Class I – Distribution" cell as "Low Risk".  Then, using these Risk-Ratings, the 2014 Revision prescribes how each Risk-Rated activity is to be regulated (in terms of filings, registrations, approvals, self-audits, external audits, quality-control, record-keeping, physical storage/transport and associated penalties).

3. Clinical trials for all imported Class II and III medical devices

For foreign producers and exporters (to China) of medical devices, perhaps the most critical change in the 2014 Revision is the requirement for all imported Class II and III medical devices to be subject to PRC clinical trials, before approval to distribute into the PRC is allowed.  It is not clear from the 2014 Revision whether "grand-fathering" exemptions (from clinical trials) will be allowed.