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Home > Medical Devices & Pharmaceuticals
China Is to Adopt Risk-based Supervisory Rules on Medical Devices
By The Compliance Reviews | 2014/4/2 16:43:55

The State Council of China revised and issued the Regulations for the Supervision and Administration of Medical Devices on March 7, 2014.  The new regulations are going to take effect from June 1, 2014.

The new regulations have eight chapters, which respectively cover general principles (Chapter 1), the registration and recordal of medical devices (Chapter 2), the manufacturing of medical devices (Chapter 3), the operation and use of medical devices (Chapter 4), the disposal of incidents and recall of medical devices (Chapter 5), the supervision and inspection (Chapter 6), legal liabilities (Chapter 7) and appendices (Chapter 8).

One of the big differences from the old regulations (2000) is that medical devices, in the new regulations, are classified and administered according to their risk levels.  Class I medical devices have low-leveled risks, for which safety and effectiveness can be ensured through routine administration.  Class II medical devices have medium-leveled risks, for which safety and effectiveness can be ensured through strict control and administration.  Class III medical devices have high-leveled risks, for which safety and effectiveness cannot be ensured without the adoption of some special measures for strict control and administration.  Following factors shall be taken into account to assess the risk level of a medical device such as its expected purpose, structure characteristics, and methods to use.

Previously, the old regulation defines Class III as the medical devices implanted into or pose potential risk to the human body -- Class III Medical Devices are those which are implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness.  The new regulations apparently abandoned this human body-related classification.

Another difference is that the new regulations provide for the recall system.  If a medical device does not abide by the compulsory standards, the registered or recorded technical specifications or have some other defects, the concerned manufacturing enterprise shall stop manufacturing the medical devices, notify the concerned businesses and individuals to stop using the medical devices, recall the sold medical devices, and adopt remedial or destroying measures.

You may follow the link for the Chinese version of the new regulations.


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