China’s Recent Measures for the Urgent Approval of Medical and Health Products Amid Coronavirus Outbreak

On 23.01.2020, the Ministry of Commerce of the PRC announced (No.3-2020) the list of intermediary services and administrative examinations and approvals for import and export of goods.

The China Chamber of Commerce for Import & Export of Medicines and Health Products continues to be responsible for the import quota monitoring of restricted goods in accordance with regulations of the Public Bidding Measures on Quota of Export Commodities and Detailed Implementation Regulations of Public Bidding on Industry Products Export Quota.

With the aim to promote integrated development of domestic and foreign trade under a well-established management system, this measure supports the reform to delegate power, streamline administration and optimize government services.

On 30.01.2020, the Yunnan Medical Products Administration announced the urgent need to import overseas medical devices to China due to the Coronavirus outbreak, and the NMPA registration process can be omitted if the following requirements are met:

– The medical device meets the US, EU, and Japan standards with a proof of overseas certification and a declaration of product safety and quality

– The medical device is considered necessary by the provincial government in China for the emergency to control the epidemic

As of 05.02.2020, the provincial counterparts of the NMPA had approved the importation even without NMPA approval for 72 categories of medical products, including:

– 2 Medical Masks
– 14 Surgical Masks, 17 Single-use Medical Masks
– 9 Single-use Medical Protective Clothing, 10 Single-use Surgical Clothing
– 2 Reusable Surgical Clothing
– 2 Single-use Medical Caps
– 1 Single-use Surgical Cap
– 1 Medical Isolation Bed
– 1 Isolation Cabin
– 1 Single-use Surgical Napkin Package
– 1 Single-use Sterile Surgical Sheet
– 1 Single-use Medical Examination Glove
– 1 Single-use Surgical Glove
– 1 Noninvasive Ventilator
– 1 Nasal Catheter
– 1 Heating Breathing Pipe
– 1 Infrared Thermometer
– 1 High-flow Humidification Apparatus
– 1 Digital Mobile X-ray Machine
– 1 Single-use Interventional Operation Package
– 1 Single-use Endotracheal Intubation Package
– 1 Single-use Sputum Suction Package

Although the NMPA registration process can be omitted, the new measure aims to strengthen the surveillance of the overseas medical devices before the import certification is issued. During the expedited registration process, the confirmation of approval must be acquired from the Medical Products Administration (MPA) at the provincial level to complete the customs clearance, in order to ensure the product safety and quality of the imported medical devices.

On 07.02.2020, SAMR (CNCA) announced that there are a total of 55 testing and inspection institutions nationally recognized for their testing capabilities on medical devices and personal protective equipment to support the epidemic prevention and control of the latest Coronavirus infection.

The number of institutions are listed with the respective testing capability in the table below:

In addition, there are another 170 testing and inspection institutions provincially recognized for the testing capabilities of personal protective equipment. Feel free to contact us if you would like to receive more information about the testing and inspection institutions.

On 07.02.2020, the National Medical Products Administration (NMPA) announced (No.71-2020) a list of measures to expedite the approval process of medical protective clothing to prevent the Coronavirus from spreading by:

–           Encouraging the expansion of the production capacity in newly added factory sites

–           Encouraging factories of other product categories to switch to produce medical protective clothing

–           Optimizing the procedures for the registration and production of medical protective clothing

–           Assigning personnel from the relevant government departments to help enterprises meet the requirements sooner

The measures announced on 07.02.2020 are temporary for the current emergency situation and will be lifted after the epidemic is over.