National Medical Products Administration: During the epidemic, emergency approval of medical device products was implemented without lowering standards

【[Global Times Report] On the afternoon of March 12, the State Council’s joint prevention and control mechanism held a press conference to introduce the strengthening of market supervision and risk investigation.

Yuan Lin, director of the Drug Supervision Department of the National Medical Products Administration, introduced that since the outbreak of the COVID-19 epidemic, in order to meet the needs of epidemic prevention and control work in a timely manner, from the National Medical Products Administration to the provincial drug supervision and administration bureaus have actively acted and quickly opened a green channel for emergency approval of medical devices, fully serving the overall situation of epidemic prevention and control.

For registration applications of medical devices needed for epidemic prevention and control, in accordance with the requirements of the emergency approval procedures for medical devices, the review and approval work is accelerated on the basis of ensuring safety and effectiveness. In particular, special measures have been implemented for the registration, production licenses, and inspection and testing of medical devices such as medical masks and medical protective clothing. Without lowering overall standards, relevant review and approval procedures are merged and integrated to fully meet the needs of epidemic prevention and control.

Here are two sets of data:

First, as of March 11, there are a total of 216 medical protective clothing medical device registration certificates nationwide. A total of 175 new certificates have been added due to emergency approval for epidemic prevention and control. There are currently 184 related production enterprises, with 143 new enterprises added due to emergency approval during this COVID-19 epidemic prevention and control. According to statistics, the maximum daily production capacity has reached more than 842,000 sets.

Second, as of March 11, there are a total of 119 medical protective mask registration certificates nationwide, with 66 new certificates added due to emergency approval for epidemic prevention and control. There are currently 96 production enterprises, and 43 new enterprises have been added due to emergency approval by the National Medical Products Administration due to the urgent needs of epidemic prevention and control. According to statistics, the maximum daily production capacity has exceeded 1.8 million.

For enterprises applying for the production of epidemic prevention-related medical devices, if they meet the requirements of the emergency approval procedures, especially for clinically urgently needed medical devices, and there are no similar products on the market domestically, or if there are similar products on the market domestically but cannot meet the prevention and control needs, they can be included in the emergency approval after confirmation through expert group review and professional technical evaluation procedures.

If enterprises encounter problems or difficulties in the review and approval process of related medical devices, they can contact the National Medical Products Administration or the provincial drug supervision departments in a timely manner, according to the different categories of medical devices applied for.