Adjustment of consultation work arrangement for technical problems before acceptance of medical devices

announcement

No. 37 in 2022

In order to comprehensively boost the development of China's medical device industry, give full play to the technical support role of the medical device innovation service station for the development of the medical device industry in the region, the leading role of Beijing in the integration of Beijing, Tianjin and Hebei, and the new benchmark role of Hainan in comprehensively deepening the reform and opening up in the new era, learn from the experience of the Yangtze River Delta Branch Center and the Dawan Branch Center for Devices in consulting technical issues before registration acceptance, Sichuan Medical Device Innovation Service Station, Jilin Medical Device Innovation Service Station, Fujian Medical Device Innovation Service Station, Beijing Drug Administration and Hainan Drug Administration will be included in the scope of technical consultation before registration and acceptance as participating units, so as to provide more high-quality and efficient consultation guidance for medical device manufacturers in the region, and simultaneously adjust the consultation arrangement of the Center. Relevant matters are hereby notified as follows:

One、Implementation unit

（1） Leading unit

As the leading unit, the Institute Audit Center is responsible for the overall management and implementation of the technical problem consultation before the registration acceptance.

（2） Participants

Equipment Yangtze River Delta Branch Center, Equipment Dawan Branch Center, Sichuan Medical Device Innovation Service Station (hereinafter referred to as "Sichuan Service Station"), Jilin Medical Device Innovation Service Station (hereinafter referred to as "Jilin Service Station"), Fujian Medical Device Innovation Service Station (hereinafter referred to as "Fujian Service Station"), Beijing Drug Administration (hereinafter referred to as "Beijing Bureau") Hainan Provincial Drug Administration (hereinafter referred to as "Hainan Bureau"), as a participating unit, carried out consultation on technical issues before registration acceptance under the guidance of the leading unit.

Two、Consultation on technical problems before acceptance of medical device registration

（1） On site consultation time

Audit Center: 13:30~16:30 every Friday (except legal holidays).

Equipment Yangtze River Delta Branch Center, Equipment Dawan Branch Center, Sichuan Service Station, Jilin Service Station, Fujian Service Station, Beijing Bureau, Hainan Bureau: from November 1, they will receive the consultation, and the consultation will be held every Thursday (except for legal holidays). The specific time period for consultation and the consultation time arrangement of each administrative counterpart shall be subject to the actual notice of each unit.

（2） Site consultation location

Instrument Examination Center: the first floor of Gate 3, Dacheng Plaza, No. 28, Xuanwumen West Street, Xicheng District, Beijing, and the administrative acceptance service hall of the State Drug Administration.

Yangtze River Delta Sub center: Floor 1, Building 5, Lane 36, Xuelin Road, Pudong New Area, Shanghai. Tel.: 021-68662180.

Dawan Sub center: Room 906, Building G, Shenzhen Hong Kong International Science and Technology Park (Guangtian International Center), No. 3, Binglang Road, Futian District, Shenzhen, Guangdong Province. Tel.: 0755-83087032.

Sichuan Service Station: F6, Jinrong Building, No. 69, Keyuan South Road, Chengdu, Sichuan. Tel.: 028-61556637.

Jilin Service Station: No. 657, Zhanjiang Road, Economic Development Zone, Changchun City, 333, the third floor of Jilin Drug Administration. Tel.: 0431-81763087.

Fujian Service Station: Fujian Drug Evaluation, Monitoring and Evaluation Center (708/709, Floor 7, Zhanqi Building, No. 156, Dongpu Road, Gulou District, Fuzhou). Tel.: 0591-87723192.

Beijing Bureau: Room 303, East Building, No. 13 Shuiche Hutong, Xicheng District, Beijing. Tel.: 010-58549948.

Hainan Bureau: 53 Nanhai Avenue, Haikou, Hainan, meeting room of Hainan Drug Administration. Tel.: 0898-66833812.

（3） Consultation object and scope

The objects and scope of technical problems consultation between the Center and participating units before acceptance are as follows:

Ⅰ. Clients

Domestic Class III medical device research and development institutions, manufacturing enterprises, and enterprise legal persons (including sole proprietorship companies, joint ventures, etc.) with equity established in China by the applicant for registration of imported medical devices.

Ⅱ. Corresponding scope

Instrument audit center: on-site consultation applications nationwide, and e-mail consultation applications outside the area of responsibility of the participating units.

Yangtze River Delta Sub center: consulting applications in Shanghai, Jiangsu, Zhejiang and Anhui.

Dawan Sub center: consulting applications in Guangdong Province, Hong Kong and Macao.

Sichuan Service Station: consulting application in Sichuan Province.

Jilin Service Station: the consultation application within the region of Jilin Province.

Fujian Service Station: the consultation application within Fujian Province.

Beijing Bureau: the consultation application in Beijing.

Hainan Bureau: consulting applications in Hainan Province.

（4） Advisory arrangements

The consultation on technical problems before acceptance of the Center still maintains the existing grouping arrangement. For specific rotation arrangement, please pay attention to the notice on arrangement of consultation on technical problems before acceptance of medical device registration regularly published on the website of the Center and WeChat official account.

The consultation on technical issues before acceptance by each participating unit is not restricted by the grouping arrangement of the Center. The domestic research and development institutions and manufacturers of Class III medical devices within the participating unit area, as well as the enterprise legal persons (including wholly-owned companies, joint ventures, etc.) with equity established in China by the applicant for the registration of imported medical devices can propose active medical devices, passive medical devices, in vitro diagnostic medical devices Application for consultation on technical issues before acceptance in terms of examination of innovative medical devices.

（5） Form of consultation

Before accepting the registration of medical devices, the consultation on technical issues shall be carried out in the form of on-site consultation (considering the epidemic prevention and control requirements, each unit can carry out video consultation according to the actual situation) and e-mail consultation, and the registration form of on-site receiving consultation will not be restored temporarily.

Ⅰ. Consulting form of the Institute Audit Center

(1) On site consultation

The administrative counterpart can make an appointment through the online reservation acceptance system of the administrative acceptance service hall of the State Drug Administration, and can choose to log in to the government affairs service portal of the State Drug Administration（ http://zwfw.nmpa.gov.cn/web/index ）, enter the online service hall, register the corporate account and log in, click the function bar "Online reservation" on the right to make an appointment. The administrative counterpart can also log on the website of the Center for Acceptance and Reporting of the State Food and Drug Administration（ http://www.sfdaccr.org.cn/ ）Click "Online reservation acceptance" on the right function bar to make an appointment.

Each evaluation department and comprehensive business department can reserve 20 on-site consultation numbers on each consultation day, and the clinical and biological statistics department can reserve 15 on-site consultation numbers. When making an appointment, the medical device research and development institutions, manufacturers, and enterprise legal persons (including wholly-owned companies, joint ventures, etc.) with equity established in China by the applicant for the registration of imported medical devices should upload the "Registration Form for Consultation on Technical Issues before Acceptance of Medical Device Registration" (see Appendix 1), "Registration Form for Consultation on Technical Issues before Acceptance of Medical Device Registration" (see Appendix 2) For the scanned copy of the business license or corporate certificate, each registration form can be filled in with up to 5 questions, which are limited to the functional scope of the department on duty at the corresponding booking port on the same day. If the consulting registration form, information registration form, business license or legal person certificate are not submitted, or the submitted questions do not fall within the scope of the corresponding consulting department, the appointment will be deemed unsuccessful and the arrangement will not be made. For the time being, on-site consultation is only available to those who have successfully made an appointment, The unit that has successfully made an appointment shall hold the power of attorney affixed with the official seal of the application unit for appointment consultation and the valid personal identity card to the administrative acceptance service hall for on-site consultation at 13:00~15:00 on the day of consultation (if the notification of the rotation arrangement for pre acceptance technical consultation issued by the Center indicates that the staff will inform the specific video conference information by phone or email before 10:00 on the day of consultation).

(2) Email consultation

Units that did not make an appointment for on-site consultation or failed to make an appointment can submit an application for consultation by mail. From 8:30 on Monday to 16:30 on Wednesday, the consultation registration form (only in word format), information registration form (only in the specified format), power of attorney stamped with the official seal of the application unit for appointment for consultation and the scanned copy of the business license or corporate certificate involving the department on duty in the current week will be sent to the designated mailbox. Please name the email with "the name of the rotation department of the machine audit center to which the inquiry belongs+the province where the applicant is located+the product name+the name of the applicant". The name of the inquiry registration form and the information registration form is the same as the email title. For example, if the infusion pump product of ABC Company in Hebei Province intends to apply for email consultation, and the consultation product belongs to the business scope of Evaluation Department I, the email name, consultation registration form and information registration form should all be named as "Evaluation Department I+Hebei+infusion pump+ABC Company". After screening the mails, the staff of the Audit Center will transfer the qualified applications to the weekly shift department before 16:00 every Friday, and the shift department will reply by email within 5 working days.

Ⅱ. Consultation form of participating units

The consultation of participating units includes on-site consultation and e-mail consultation. Before online reservation conditions are met, the consultation shall be made by e-mail. The equity holding enterprise legal persons (including sole proprietorship companies, joint ventures, etc.) established in China by domestic Class III medical device development institutions, manufacturing enterprises, and imported medical device registration applicants within the region of each participating unit,The consultation registration form (only in word format)、The information registration form (only the specified format is accepted), the power of attorney stamped with the official seal of the applicant for appointment consultation, and the scanned copy of the business license or legal person certificate are sent to the designated mailbox (see Annex 3). Each registration form can be filled with up to 5 consultation questions.

For those who apply for on-site consultation, please name the email as "on-site+name of the organ audit center to which the question belongs+province of the applicant+product name+name of the applicant". The name of the consultation registration form and information registration form is the same as the email title. For example, Zhejiang XYZ Company's infusion pump products are intended to apply for on-site consultation with participating units, and the consultation product belongs to the business scope of the First Evaluation Department of the Center for Instrument Review, so the email name, consultation registration form and information registration form should all be "on-site+First Evaluation Department+Zhejiang+infusion pump+XYZ Company". If you apply for email consultation, please name the email as "the name of the organ audit center department to which the inquiry belongs+the province where the applicant is located+the product name+the name of the applicant". The name of the consultation registration form and information registration form is the same as the email title. For example, Zhejiang XYZ Company's infusion pump products are intended to apply for email consultation, and the consultation product belongs to the business scope of the Evaluation Department I of the Equipment Audit Center, so the email name, consultation registration form and information registration form should all be "Evaluation Department I+Zhejiang+infusion pump+XYZ Company". After filtering the mails, all participating units shall sort out the qualified mails according to the order of submission.

Each participating unit shall confirm the specific consultation time by telephone according to the order in which the applicant submits the effective application for on-site consultation, and send the information related to the successful appointment by e-mail. The applicant who has successfully made an appointment shall consult at the place designated by the participating unit at the agreed time with the power of attorney affixed with the official seal of the applicant, the consultation registration form, the valid ID card and the email of successful appointment.

If the effective application for on-site consultation submitted weekly by the applicant within the area of each participating unit fails to arrange on-site consultation, or if the applicant directly applies for e-mail consultation, each participating unit shall reply by e-mail within 10 working days.

All participating units shall carry out pre acceptance technical consultation based on the consensus contents such as common question answers, review guidelines, and review points that have been formed by the Center. Before replying to the consultation opinions, each participating unit shall collectively study the questions in the consultation registration form to form a reply. For the questions that need to be further confirmed or beyond the scope of the consultation process and can not be answered by each participating unit, each participating unit shall make records and uniformly feed back the questions to the Institute Audit Center within the specified time. After the corresponding department studies and forms the reply opinions, each participating unit shall reply.

（6） Precautions

Ⅰ. From the date of promulgation of this circular, domestic Class III medical device research and development institutions, manufacturing enterprises and imported medical device registration applicants within the region of each participating unit can make an appointment for on-site consultation. They can select either the audit center or the participating unit in the region where they live, but not the participating unit in the region where they do not live; The email consultation applications of medical device research institutions, manufacturers and imported medical device registration applicants in the regions of all participating units shall be uniformly sent to the email address of the participating units in the regions where they live, and shall not be sent to the email address of the rotating department of the Certification Center.

Ⅱ. If the name of the mail does not meet the requirements, the name of the applicant in the mail name is inconsistent with the power of attorney, the format of the consultation registration form is wrong, the consultation content is inconsistent with the functions of the shift duty department of the week, the consultation application for the week is not submitted within the specified time (8:30 on Monday to 16:30 on Wednesday of the week), the consultation application is not submitted to the correct mailbox, and the consultation information registration form is not filled in correctly, the application is deemed invalid, The consulting and screening staff will reply directly and will not transfer to another office.

Ⅲ. In order to meet the consulting needs of more medical device development institutions and manufacturers in the area of each participating unit, each unit can only submit one on-site appointment application per week, and more than one will be considered as an e-mail consultation application, and no on-site consultation will be arranged.

Ⅳ. For the appointment consultation arranged by the participating units, the consultants shall handle the consultation according to the appointment time. If they fail to arrive at the appointment time, they shall be deemed as having broken the appointment and recorded once. For each time of breaking the appointment, the participating units will suspend receiving on-site consultation for 3 months. If they break the appointment for 3 times, the participating units will suspend receiving on-site consultation.

Ⅴ. The on-site consultants shall be the on-the-job personnel of the company that has successfully made an appointment. It is strictly prohibited to resell or transfer the on-site consulting qualification. It is prohibited to entrust the personnel of the company that has not made an appointment to conduct consulting. Once it is found, the Machine Audit Center and the participating units will suspend receiving the consulting from the company.

Ⅵ. During the normalization of epidemic prevention and control, the number of on-site personnel shall be strictly controlled. Each appointment number is limited to one person and shall be consistent with the appointment information. Due to the limited consultation time and space, in order to ensure the consultation effect and maintain the on-site order, please obey the command of the on-site staff.

Ⅶ. Before going to the appointed place for on-site consultation, the consultants should confirm whether the relevant personal information conforms to the local epidemic prevention and control policy. If the on-site consultation cannot be carried out after the appointment due to non-compliance with the epidemic prevention and control policy, the consequences should be borne by themselves.

（7） Contact information

If you have any questions about the technical questions before the acceptance of the registration of medical devices, you can call the following number during working hours:

Audit Center: 010-88331776

Yangtze River Delta Sub center: 021-68662180

Dawan Sub center: 0755-83087032

Sichuan Service Station: 028-61556637

Jilin Service Station: 0431-81763087

Fujian Service Station: 0591-87723192

Beijing Bureau: 010-58549949

Hainan Bureau: 0898-66833812

The above contents shall come into effect as of the date of issuance of this circular. In case of any discrepancy between the relevant provisions on consultation arrangements for technical issues before acceptance issued by our center and this circular, this circular shall prevail.

It is hereby notified.

Appendix:
1. Consultation Registration Form

2. Information Registration Form

3. Receiving mailbox for technical questions before acceptance

State Drug Administration

Medical Device Technical Evaluation Center

October 16, 2022