Upcoming CFDA Inspection on Class I and Class II Medical Devices Manufacturers
The China Food and Drug Administration (“CFDA”) issued a new circular on 1 September 2017 (Shi Yao Jian Ban Xie Jian (2017) No.120), namely Circular related to the Work for Implementing Medical Devices Manufacturing Quality Management Standards to Class I and Class II Medical Devices Manufacturing Companies.
This Circular actually serves to promote the implementation of the Medical Devices Manufacturing Quality Management Standards issued by the CFDA effective as of 12 December 2014 as well as the Circular of CFDA related to Certain Issues related to the Implementation of Quality Management Standards in the Production of Medical Devices dated 5 September 2014 (Circular (2014) No.15).
Circular (2014) No.15 provides for the specific deadlines for different domestic medical devices manufacturing companies to gradually meet the Medical Devices Manufacturing Quality Management Standards 1 . According to this Circular (2014) No.15, as from 1st January 2018, all the medical devices manufacturing companies must comply with the Medical Devices Manufacturing Quality Management Standards. Therefore, the new circular (Shi Yao Jian Ban Xie Jian (2017) No.120) emphasizes that the above requirements to comply with Medical Devices Manufacturing Quality Management Standards must be met on time, especially for class I and class II medical devices.
This new circular requires that class I and class II medical devices manufacturers must make a thorough self-inspection according to article 24 of the Regulation on the Supervision and Administration of Medical Devices (i.e. requirement to establish quality management system and maintain the effective operation of the system and implementation of regular self-inspection and reporting to food and drug administration) and the Medical Devices Manufacturing Quality Management Standards. If they cannot meet the Medical Devices Manufacturing Quality Management Standards as of 1st January 2018, they must cease manufacturing activities and make report to the municipal food and drug administration (“FDA”) where they are located.
As from 1st January 2018, the FDAs at provincial level shall organize inspections on class I and class II medical devices manufacturing companies located in their respective regions in strict compliance with the Medical Devices Manufacturing Quality Management Standards. At least 50% of the companies shall be selected by FDAs at random for inspection. Any company that fails to establish quality management system or maintain the effective operation of such system according to the Medical Devices Manufacturing Quality Management Standards shall be sanctioned according to Article 66 of the Regulation on the Supervision and Administration of Medical Devices (i.e. a fine of at maximum 10 times of the value of the goods sold till cancellation of medical devices manufacturing licence/filing certificates). If any company fails to comply with the Medical Devices Manufacturing Quality Management Standards and refuses to make rectification or refuses to cease manufacturing according to the regulations, the FDA shall impose sanction according to Article 67 of the Regulation on the Supervision and Administration of Medical Devices (i.e. a fine of at maximum 30,000 RMB till the cancellation of medical devices manufacturing licence/filing certificate).
Apart from the above provisions, the new circular also stipulates that the local FDAs shall also carry out unannounced inspection on class I and class II medical devices manufacturing companies as it considers appropriate.
Class I and class II medical devices manufacturing companies shall pay extreme attention to this upcoming inspections to be launched in 2018 and be prepared for inspection in compliance with the Medical Devices Manufacturing Quality Management Standards.
1 Circular (2014) No.15 stipulates that as from 1st October 2014, all newly-established medical devices manufacturing companies, all existing medical devices manufacturing companies which plan to extend its scope of manufacturing to class III medical devices, all existing medical devices manufacturing companies which plan to relocate or set up new manufacturing site, it shall comply with the Medical Devices Manufacturing Quality Management Standards. As from 1st January 2016, all existing medical devices companies manufacturing class III medical devices shall comply with Medical Devices Manufacturing Quality Management Standards. As from 1st January 2018, all medical devices companies shall comply with Medical Devices Manufacturing Quality Management Standards.
