CFDA revised Medical Device Regulations

The China Food and Drug Administration (CFDA) have adopted the draft amendment to the Regulations for the Supervision and Administration of Medical Devices at the executive meeting of the State Council on February, 2014. The regulations will be proclaimed and implemented soon.

The managing director of UL India and South Asia said that Given the rapid growth curve of the Indian pharmaceutical industry, it is quite natural that the spotlight is on Indian companies adherence to good manufacturing practices. We need to look at this increased regulatory scrutiny more as an opportunity for them. This calls for a universal understanding of good manufacturing practices (GMP) guidelines, rightful implementation and fool proof audit processes to ensure consistency.

After the comprehensive revision of the regulations, the draft amendment to the Regulations consists of 80 articles in eight chapters. The amendments to the regulations are as follows:

•  adjustment of the definition and classification rules of medical devices;
•  a further improvement of the authority management for product registration, approval or record keeping of    manufacturing and distribution of medical devices;
•  a set up of measures for quality supervision and risk control during the manufacturing of medical devices;
•  the establishment of systems for adverse event monitoring, tracing and recall of medical devices;
•  the further strengthening of inventory management, examination and acceptance system, and certificate claim in the    distribution of medical devices;
•  an addition of relevant requirements on supervision of the medical devices in use; and
•  the increase of punishments for illegal activities.