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Issue 08, 2008 (01 August)
 Industrial Policy

New Safety Standard for Medical Electrical Equipment Takes Effect

The new national standard GB 9706.1-2007, Medical Electrical Equipment - Part 1: General Requirements for Safety, has been approved by the Standardisation Administration of China and took effect on 1 July 2008. To implement the new standard effectively and ensure the safety of medical electrical equipment available on the market, the State Food and Drug Administration (SFDA) has issued a circular setting out the following requirements:

  1. With the implementation of GB 9706.1-2007, all medical electrical equipment manufacturers should adhere to the requirements set out in the new standard in the course of production.

  2. For medical electrical equipment that is certified in accordance with the original standard, the manufacturers should follow the new requirements under GB 9706.1-2007 and re-apply for certification before the current certificate expires.

  3. With the implementation of GB 9706.1-2007, all relevant testing organisations should carry out the required tests and issue the respective certificates in accordance with the new standard. For medical electrical equipment which had passed the certification tests and was granted certification test report under the original standard before the new standard took effect, the report will continue to be a valid document for filing a new application. The safety requirements under the original standard may still be applied during the examination and approval process.

  4. Starting from the date the circular was issued, safety information about medical electrical equipment is not required to be listed separately in the form of appendix to the product certification standard. Instead, applicable information such as compliance with national safety standard or industry standard or the major safety features of the product concerned should be stated in the sequence as stipulated in the standard.

  5. The YY 0505-2005 standard, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, as quoted in the GB 9706.1-2007 standard will be implemented in accordance with SFDA Circular No. 499 [2006] issued in relation to the deferred implementation of YY 0505-2005. The IEC 60601-1-4: 2004 standard, Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems, as quoted in the GB 9706.1-2007 standard will be implemented upon its conversion into a medical equipment standard and subsequent promulgation.