Implementation Guide for Medical Device Production Release by Medical Device Manufacturers under the Guangdong Province Medical Device Registrant System

Medical device enterprises in Guangdong Province:

In accordance with the requirements of the "Implementation Plan for the Pilot Program of the Medical Device Registrant System in Guangdong Province," the Guangdong Medical Device Management Association, in cooperation with the Guangdong Provincial Drug Supervision and Administration Bureau, organized industry experts to draft and solicit opinions from some enterprises and research institutions, and revised the supporting recommended document for the medical device registrant pilot program, "Guangdong Provincial Implementation Guide for Medical Device Production Enterprise Production Release under the Medical Device Registrant System" (hereinafter referred to as the "Guide"), which is now open for public comment.

After receiving this notice, please provide your comments on the "Guide" in electronic form to the Association's email address: GDMDMA@163.COM. The deadline for comments is December 16, 2019.

Attachment: "Guangdong Provincial Implementation Guide for Medical Device Production Enterprise Production Release under the Medical Device Registrant System (Draft for Comments)"

Attachment

Guangdong Provincial Implementation Guide for Medical Device Production Enterprise Production Release under the Medical Device Registrant System

(Draft for Comments)

Medical device manufacturing enterprises (hereinafter referred to as "enterprises") should strengthen the management of the entire product realization process, especially the production release of medical devices, in accordance with the requirements of the "Medical Device Production Quality Management Specifications" (Announcement No. 64 of 2014, State Food and Drug Administration) and its appendices, to ensure that the released medical devices meet the mandatory standards and the technical requirements of the registered or filed products.

I. Basis for Formulation

In order to standardize the quality management practices of medical device registrants in commissioned production activities, clarify the division of responsibilities for production release in the medical device production process, ensure the effective connection and operation of the quality management systems of the commissioning and commissioned parties, and effectively safeguard the quality and safety of medical devices, this "Guangdong Provincial Implementation Guide for Medical Device Production Enterprise Production Release under the Medical Device Registrant System (Trial Implementation)" (hereinafter referred to as the "Guide") is formulated in accordance with the requirements of "Opinions of the General Office of the CPC Central Committee and the General Office of the State Council on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices," "Notice of the State Council on Issuing the Comprehensive Deepening Reform and Opening-up Plan for the China (Guangdong) Pilot Free Trade Zone," "Regulations on the Supervision and Administration of Medical Devices," "Implementation Plan for the Pilot Program of the Medical Device Registrant System in Guangdong Province," and "Guangdong Provincial Implementation Guide for the Medical Device Registrant Production Quality Management System (Trial Implementation),", and combined with the actual situation of this province.

II. Scope of Application

Production release refers to the process where the consignee reviews the production process records and quality inspection records of a batch of medical devices to confirm that the production has been completed in accordance with the "Medical Device Production Quality Management Specifications", its appendices, and the technical documents determined by both parties, and that it fully meets the requirements specified by both parties regarding raw materials, intermediate process control, and the inspection requirements for incoming, process, and finished products. After the consignee confirms that the product meets the "Medical Device Production Quality Management Specifications", its appendices, and the acceptance standards agreed upon by both parties, it can be released and delivered to the registrant.

The production release referred to in this Guide does not include the release procedures for purchased goods and intermediate products. Enterprises can formulate their own release procedures for purchased goods and intermediate products with reference to the principles of finished medical device release. Similarly, this Guide also does not include the product market release under the medical device registrant system.

III. Medical Device Production Release

(1)Division of Responsibilities between Registrant and Consignee

The medical device registrant shall determine the method of product market release and put forward requirements for the consignee's production release. The production release requirements should be clearly defined in the quality agreement between the registrant and the consignee.

The medical device consignee is responsible for organizing production in accordance with the medical device commissioned production quality agreement and the "Medical Device Production Quality Management Specifications" and its appendices, and bears the corresponding quality responsibility for the medical devices produced for the registrant. The medical device consignee is responsible for product production release and should implement the production release procedure in accordance with the medical device commissioned production quality agreement.

(2)Formulation of Production Release Requirements

In principle, the medical device registrant should formulate product production release requirements based on mandatory standards, registered or filed product technical requirements, product delivery requirements, and enterprise internal control standards, and transfer the production release requirements to the consignee, review and authorize the production release personnel. If the registrant needs to entrust the consignee to establish production release requirements, it should authorize the consignee after a systematic assessment.

The consignee shall implement quality control activities in accordance with the division of responsibilities for quality control processes such as quality standards, inspection responsibilities, sample retention, and observation (if applicable) for the commissioned products as agreed in the medical device commissioned production quality agreement. The consignee is responsible for production release and should ensure that the commissioned products meet the registrant's acceptance standards and retain release records.

(3)Implementation of Production Release The medical device registrant should establish and implement a production release procedure, clarifying the production release conditions and release approval requirements.

Before the production release of medical device products, at least the following conditions should be met:

(1)All specified process flows are completed;

(2)The specified batch production records are complete and accurate;

(3)All specified incoming, process, finished product inspection, verification, and other quality control records are complete and accurate, and the results meet the specified requirements. Inspection/test/verification/confirmation personnel and their review and authorization personnel have all signed and issued records as required;

(4)Nonconformities, rework, repairs, downgrading, emergency release, and other special situations in the entire product realization process, especially in the procurement and production processes, have been handled in accordance with the regulations;

(5)The product Description, labels, and their versions meet the specified requirements;

(6)Authorized release personnel have signed and issued product release forms as required, approving the release of finished products.

(7)Approved production release products should be accompanied by a certificate of conformity. The registrant should formulate enterprise internal procedural documents or working documents corresponding to production release.

(4)Other Requirements for Production Release In principle, the medical device registrant shall not adopt the following release standards:

(1)For major raw materials, parts, and components with a significant impact on finished product quality, only visual inspection and verification of the supplier's finished product inspection report are implemented, and the key quality control performance indicators of the above-mentioned purchased goods are not inspected/tested/verified/confirmed before release;

(2)Intermediate products and finished product key quality control performance indicators for key processes are not inspected/tested/verified/confirmed before circulation;

(3)Failure to confirm the process parameters of special processes, or failure to implement effective monitoring and measurement of special processes after confirmation, resulting in the release of intermediate products and finished products;

(4)For important quality control performance indicators of finished products, only incoming inspection and process inspection data are transferred for release;

(5)Finished product inspection does not cover the inspection items and methods that should be routinely controlled in the registered or filed product technical requirements, and no reasonable reason is given.

If, after risk assessment, it is necessary to use the above methods to release some purchased materials, intermediate products and finished products, the registrant should carry out strict pre-supplier management for the relevant purchased materials, intermediate products and finished products and their related processes, and conduct appropriately frequent inspections/tests/verifications/Confirmations within a certain period. Only if the accumulated relevant data can prove that the quality control activities in the entire process of its product, especially the purchasing and production processes, are appropriate, sufficient and effective, can a simplified quality control plan be implemented.

The registrant shall establish and implement data analysis procedures. The registrant shall collect quality control operation data related to product quality control and finished product release, use appropriate statistical techniques to regularly conduct trend analysis of the relevant data, form phased product quality control reports, alert possible deviations, handle deviations or out-of-limit events as required, and take corrective and preventive measures in a timely manner if necessary. The registrant shall regularly review the suitability, sufficiency and effectiveness of product quality control and finished product release control, and implement necessary follow-up measures.

IV. References

(1) "Regulations on the Supervision and Administration of Medical Devices" (2017 amended version)

(2)"Draft Amendment to the Regulations on the Supervision and Administration of Medical Devices (Draft for Review)"

(3)"Methods for the Supervision and Administration of Medical Device Production" (Order No. 7 of the State Food and Drug Administration)

(4)"Announcement of the State Food and Drug Administration on the Release of the Good Manufacturing Practice for Medical Devices" (No. 64 of 2014)

(5)"Notice of the Guangdong Provincial Food and Drug Administration on Issuing the " (2018.08.20)

(6) Announcement of the Guangdong Provincial Drug Administration on the Release of the (2018.7)