Chang-Hong Whitney09.08.06
China’s State Food and Drug Administration (SFDA) issued a new document in May that mandates all medical electrical and electronic products to comply with GB9706.1-1995 (identical to IEC60601.1-1988) before bringing products to market. Notification on Implementation of GB9706.1-1995 on Medical Electronic Products requires that all medical products that are undergoing the registration process, as well as those already registered, now must provide sufficient information to demonstrate that the product has been adequately tested according to this standard.
Foreign companies that already have tested their products by international IEC testing houses, in compliance with IEC60601.1, can provide a copy of the IEC report for review and validation by the SFDA testing center. Manufacturers are required to submit to the SFDA the final evaluation report by the SFDA testing center, a notarized copy of the original IEC report and a Chinese translation of the document.
According to the new GB9706 regulation, any company that cannot provide the full IEC report from overseas is required to conduct full testing again at an SFDA-authorized testing center. For products that are registered and on the market already, suppliers are required to complete the review process by Dec. 31, 2007.
While this regulation further demonstrates the SFDA’s intention to continue improving product safety, implementation of this regulation was sudden, with no prior announcement or grace period. Companies that have products in the registration process have suffered, especially as the SFDA tried to formulate the implementation steps after announcement of this policy.
Foreign companies that already have tested their products by international IEC testing houses, in compliance with IEC60601.1, can provide a copy of the IEC report for review and validation by the SFDA testing center. Manufacturers are required to submit to the SFDA the final evaluation report by the SFDA testing center, a notarized copy of the original IEC report and a Chinese translation of the document.
According to the new GB9706 regulation, any company that cannot provide the full IEC report from overseas is required to conduct full testing again at an SFDA-authorized testing center. For products that are registered and on the market already, suppliers are required to complete the review process by Dec. 31, 2007.
While this regulation further demonstrates the SFDA’s intention to continue improving product safety, implementation of this regulation was sudden, with no prior announcement or grace period. Companies that have products in the registration process have suffered, especially as the SFDA tried to formulate the implementation steps after announcement of this policy.