Measures for the Supervision and Management

 of Medical Device Operation

Project introduction

GSP is Good Supply Practice, which refers to the management system formulated to ensure that drugs meet quality standards in the drug distribution process, covering the planned purchasing, incoming inspection & acceptance, storage, sales, and after-sales service; with the development of the industry and the improvement of the supervision, this requirement has been gradually integrated into the management requirements of medical device operation.

Legal basis

In accordance with a series of regulatory requirements and notices successively promulgated by the NMPA, such as the Measures for the Supervision and Management of Medical Device Operation and the Good Supply Practice, from October 1, 2014, the operation licensing and recording of new medical device operators shall be handled in accordance with the relevant provisions in the Measures for the Supervision and Management of Medical Device Operation.

In order to improve the scientific supervision of medical device operation, medical device operators need to meet the requirements for hardware equipment and facilities, organization and personnel, and establishment and implementation of rules and regulations. The drug administration department will follow the Good Supply Practice - On-site Inspection Guidelines to conduct the on-site inspection.

Inspection standards

In accordance with the inspection items contained in the Good Supply Practice - On-site Inspection Guidelines and the corresponding key inspection contents, the implementation of the Good Supply Practice by medical device operators is checked: The drug regulatory authority conducts the on-site inspection of the operation license (including change and renewal) of the Class III medical device wholesale/retail enterprises, the on-site inspection of the Class II medical device wholesale/retail enterprises after the operation recording, and the various supervision and inspection of medical device operators.

Scope of application

The on-site inspection of the operation license (including change and renewal) of the Class III medical device wholesale/retail enterprises, the on-site inspection of the Class II medical device wholesale/retail enterprises after the operation recording, and the various supervision and inspection of medical device operators.

Inspection items

1.   On-site inspection of the operation license (including change and renewal) of the Class III medical device wholesale/retail enterprises:

a)  If all the applicable items of the operator meet the requirements, the conclusion is “Pass”.

b)  If there are key items that do not meet the requirements or the number of nonconforming general items is > 10%, the conclusion is “Fail”.

c)  If all key items meet the requirements, and the number of nonconforming general items is ≤10%, the conclusion is “Rectify within a specified period of time”. That is to say, the enterprise shall complete the rectification within 30 days after the on-site inspection and submit the rectification reports all at once to the original review department. After the re-inspection, if all the rectification items meet the requirements, the drug regulatory authority will make a written decision of approval; if the rectification reports are not submitted within 30 days or there are still nonconforming items after the re-inspection, the food and drug regulatory authority will make a written decision of rejection.

d)  Proportion of nonconforming general items = number of nonconforming general items / (total number of general items - number of reasonably missing general items) * 100%.

2. On-site inspection of the Class II medical device wholesale/retail enterprises after the operation recording, and on-site inspection in various supervisions and inspections of medical device operators:

If all the applicable items of the operator meet the requirements, the conclusion is “Pass”; if there are items that do not meet the requirements, the conclusion is “Rectify within a specified period of time”.

Service contents

SUNGO can provide professional and personalized GSP related services for customers with different needs:

--For the wholesale/retail enterprises which have just entered the medical device industry, we can provide comprehensive and systematic services, including:

·  Establish, implement, operate and maintain the quality management system

·  Prepare the quality management system documents

·  Track the current status of the enterprise’s software and hardware on site, and conduct a comprehensive and full review of the GSP conformity

·  Counsel the enterprise on the warehousing, facilities & equipment, staffing, and logistics, and propose and implement the plans and schemes

·  Counsel the enterprise on the verification and validation of the processes in operation activities

·  Counsel the enterprise on the establishment and implementation of key processes such as purchasing, acceptance, sales, delivery, return, adverse event monitoring, advisory notification, and reporting

·  Provide technical counseling during the on-site inspection by the regulatory authority, and provide counseling on the correction and prevention of nonconforming items, and the preparation of relevant report documents

·  Carry out special training on GSP related regulations and standards

--For the wholesale/retail enterprises which have established and operated quality management systems and have obtained domestic operation licenses/recording certificates, we can provide the following services:

·  Assist the enterprise in the collection and promotion of and training on new regulations and standards

·  Counsel the enterprise on the review and update of the quality management system documents

·  Conduct a comprehensive review of each process activity during the business operation and propose and implement the rectification schemes

·  Organize and optimize the key processes of the enterprise, such as purchasing, acceptance, sales, delivery, return, adverse event monitoring, advisory notification, and reporting

·  Counsel the enterprise on the reverification and revalidation required in each business operation process

·  Regularly update the risk management and adverse event monitoring information

·  Assist the enterprise in completing the operation licensing or recording and various supervision and inspection items related to on-site inspection

SUNGO service process