On December 16, 2009, the State Food and Drug Administration of China (“SFDA”) published a package of medical device GMP regulations, which will become effective on January 1, 2011. Device manufacturers in China will need to re-examine carefully the GMP compliance status of their operations.

In addition, on December 7, 2009, SFDA published yet another draft of drug GMP for public comment. A few, but significant, changes are noted.

  1. Medical Device GMP Regulations

SFDA started pilot device GMP certification programs in December 2006. In May 2008, aiming at industry-wide implementation, SFDA published 8 draft device GMP regulations for public comment. The device GMP regulations that SFDA published in December 2009, though “interim” in their titles, will have binding force after being effective. These regulations include:

  • Medical Device GMP (Interim);
  • Rules for Administration of Medical Device GMP (Interim) (“Administration Rules”);
  • Medical Device GMP: Implementing Rules and Evaluation Guidelines for Implantable Devices (Interim); and
  • Medical Device GMP: Implementing Rules and Evaluation Guidelines for Sterile Devices (Interim).  

The Medical Device GMP sets forth the general GMP requirements, with key chapters including management responsibility; document control; design and development; production control; distribution and servicing; nonconforming product; complaints and Adverse Event monitoring, etc. Notably, the GMP explicitly provides that manufacturers may, based on the characteristics of a specific device product, determine GMP requirements that are not applicable to such product by explaining the reasonableness of the inapplicability.

The Administration Rules sets forth the scope of and procedures for GMP certification. Highlights include:

  • Manufacturers of Class I devices must set up a quality system pursuant to the requirements of the Device GMP, while manufacturers of Class II and III devices must apply for, and obtain, GMP certification after self-inspection. However, no statutory timeline for obtaining the certification is specified.
  • SFDA is responsible for GMP certification of high-risk Class III devices,1 and provincial FDAs are responsible for that of Class II devices and all other Class III devices.
  • Provincial FDAs shall conduct GMP review on manufacturers of devices on the Priority Monitoring List of SFDA or provincial FDAs at least once a year.
  • The two Implementing Rules require that, starting from July 1, 2011, manufacturers of implantable devices and sterile devices must obtain GMP certification before they file initial registration or re-registration of these devices with SFDA.
  1. New Draft of Drug GMP

The new draft of drug GMP that SFDA published on December 7 made several changes to the earlier draft of September 23, 2009 (please see here). Highlights of the changes include:

  • The provisions requiring a Quality Management Head is deleted, whose responsibilities is transferred to the Qualified Person.
  • The requirements for dedicated facilities and equipment are expanded to cover highly active, highly toxic and highly sensitizing drug products.
  • Adverse Drug Event reporting requirements are deleted from the drug GMP, while such requirements are still maintained under relevant ADE reporting rules of SFDA.
  • Cleaning requirements for sterile drug are modified in line with WHO GMP guidelines and EU GMP.
  1. Observations

While multinational drug companies that comply with U.S. device Quality System Regulations (QSR) or EU device GMP for manufacturing in China may not encounter great difficulty in meeting China’s device GMP requirements, there are sufficiently specific requirements that merit a comprehensive review of manufacturing activities in China to ensure strict compliance.

A significant uncertainty attendant to the device GMP regulations is the timeline for mandatory GMP certification and the implications for device registration process. Device manufacturers are advised to watch for any SFDA clarification on this requirement.

As to the drug GMP, the comment period for the new draft ended on December 20, 2009. SFDA still has not announced an issuance or implementation date for final regulations.