CFDA has just published two new draft lists and are now out for consultation… Read below to find out more.
Draft – CFDA Exemption list of Class II & Class III device for local clinical study – Wave 2.
On May 20, 2016 CFDA published the draft of the ‘Exemption list of Class II & Class III device for local clinical study – Wave 2’ and is asking for industry comments by June 20, 2016.
There are 259 Class II devices and 93 Class III in the proposed exemption list. When finalised and put into effect, the enlisted devices will gain automatic exemption from doing a local clinical study in China or needing to do a full clinical evaluation. Instead, the enlisted device manufacturer only needs to identify a substantial equivalent ( SE ) device which is already marketed in China, then make a comparison table for this SE device. This approach will significantly reduce the efforts and cost of bringing the device into China market. The Wave 1 of this exemption list had been put into effect on Oct 1, 2014 along with the new medical device registration rule < Order No. 4 > . There are 488 Class II and 79 Class III devices in the existing Wave 1 list.
Draft – Revised Articles to Order No. 650
On May 4, 2016 CFDA published the draft of revised articles to Order No. 650 < Medical Device Administration Rule > seeking industry comments by Jun 4, 2016.
The proposed changes to Order No. 650 will specify how medical institutes purchase “Large Medical Equipment”. The definition of “Large Medical Equipment “ is defined as “those big size equipment with complicated technology, expensive price, high operating cost, big impact to medical expenditure, and will be put into a particular administration catalog” . Medical institutes will need to obtain permission from local provincial Administration of Public Health ( APH ) to purchase “Large Medical Equipment”. If they fail to obtain approval prior to purchasing, they will receive penalty from local APH. However, the timeframe and cost of obtaining such purchasing permission was not disclosed in the revised draft. APH will work out the detailed procedure for “Large Medical Equipment “ catalog separately.
The purpose of this regulation change is to make sure the Large Medical Equipment are distributed evenly across the country and are fully utilized, in order to avoid any waste investment and negative competition among medical institutes.
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