Shanghai innovative medical device registration guidance service work standard

In order to implement the innovation-driven development strategy, further promote the reform of the medical device review and approval system, optimize the registration service guidance of innovative medical devices before listing, and establish the work specification for the registration guidance service of innovative medical devices in this city.

I. Scope of services

This Specification applies to the examination of medical devices that meet one of the following circumstances:

i.  The applicant in this city intends to apply for service consultation on the special review procedure for Class II or Class III innovative medical devices;

ii. Consultation on product registration services that have entered the special review process for Class II innovative medical devices in this city, including product technical requirements, clinical evaluation, design transformation, production quality management system, etc;

iii. Consultation and registration tracking guidance on product registration system services that have entered the special review process for Class III innovative medical devices in this city,

II.  Responsible department

The Medical Device Registry Dept of Shanghai MPA (hereinafter referred to as the “Device Registry”) is responsible for the guidance services before the preliminary examination of the innovation declaration of the Class III medical device in Shanghai and the registration tracking guidance of products entering the innovation channel.
Shanghai Medical Devices and Cosmetics Review and Verification Center (hereinafter referred to as the “Device Review Center”) is responsible for the declaration and pre-registration consulting services of the Class II innovative medical devices in Shanghai, as well as the consulting services of the Class III medical devices quality system that has entered the national innovation special review procedure.

III. Service content

i. Class II renovative Device

（i）Products intended to apply for entry into the City’s special examination procedures for Class II innovative medical devices
The applicant may submit or mail the relevant application materials to the Administrative Service Center of Shanghai MDA (hereinafter referred to as the Administrative Service Center) in accordance with the requirements of Shanghai Special Review Procedure for Class II Innovative Medical Devices and Shanghai Special Review Guide for the Preparation of Application Materials for Class II Innovative Medical Devices (Trial) before formally submitting the application for Special review. Address: Floor Hall, Building 3, No. 728 Yishan Road). The Center set up an innovation review service team to complete the pre-review within 10 working days after receiving the data.

(ii) Products that have entered the special review process for Class II innovative medical devices in this city and have not yet been registered and accepted

The Class II medical device innovation service group shall be established by the Device

Audit Center, and the contact person shall be designated to provide full service and track the progress. In accordance with the principles of early intervention, specially assigned tracking and scientific review, the service group mainly carries out pre-registration guidance services for product technical requirements, clinical evaluation, design transformation and production quality management system.  A pre-examination can be applied for the first submission of registration application information and correction information.

(iii) Service duration

Once the product registration application is submitted and accepted, the pre-service will be automatically terminated.

i. The Class ii innovative medical devices

(i) Products to be declared for preliminary examination of the national innovative medical device special review procedure
The applicant shall send the main information of the product, the Application Form for Consultation of Advance Service Product (Attachment 2) and the contact information of the applicant to the email address of the Device Registry (qxzcc@smda.gov.cn). The title of the email shall be named in the format of “Application for the Class III

 Innovation Channel – Product Name – Short name of Enterprise”. Upon receipt of the relevant information, the Device Registry shall, Designate a special person to connect with the enterprise, carry out the guidance of application materials before the preliminary examination, and complete the preliminary examination.

(ii) Products that have entered the national innovative medical device special review procedures and have not yet obtained registration certificates
The Device Registration Office is responsible for providing full tracking and guidance on the registration of products entering the national innovative medical device special review process, seeking guidance from the Centre for Medical Device Evaluation. NMPA (hereinafter referred to as the “National Audit Center”) and Yangtze River Delta for Medical Device Evaluation and Inspection of NMPA (hereinafter referred to as the “Yangtze River Delta Sub Center”) and assisting applicants in communication and exchange.

The Device Audit Centre is responsible for providing pre registration service guidance for the design transformation and production quality management system of products that have entered the national innovative medical device special review program (terminated after the product is officially registered and accepted), the applicant will submit in person or by mail to the Administrative Service Centre the documents proving that the product has entered the special review procedure for innovative medical devices of the NMPA, the “Application Form for Consultation Issues on Products of Pre-existing Services” (Attachment 2) and the contact information of the enterprise.

(iii) Service mode

On The basis of full research and collective consultation, the Device Audit Center replies by telephone, mail, remote video, on-site communication and other forms, and makes a good record of the replies. If the consultation question belongs to the information that has been publicly released such as regulations and processes or the common question answering category that has been published by the wechat public account of the Center for Audit, the applicant will be informed of the inquiry path.

(iv) Service duration

After the Class III innovative medical devices obtain the medical device registration certificate in accordance with the special review procedure, or the applicant clearly informs the innovative product no longer applies for registration within the time limit, the product guidance service will automatically terminate.

Ⅳ. Job specification

i. The intended use, technical characteristics and mechanism of the innovative products for which the applicant intends to apply are clear, and the products have been basically finalized.

ii. The applicant has no serious defects such as violations of laws and regulations, integrity problems and other serious defects in the important supervision processes such as clinical trial verification, supervision and inspection or supervision and sampling inspection in the last three years, resulting in production suspension and rectification.

iii. Relevant departments involved in innovative product registration guidance services shall strictly abide by relevant requirements such as laws and regulations, work discipline, confidentiality discipline and integrity.
These specifications shall come into force as of the date of promulgation and shall be interpreted by the Shanghai MPA.

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Source: Shanghai MPA

Translated & edited ： Bradyknows