Medical protective clothing becomes “Zhongshan-made”
Medical protective clothing is protective clothing used by clinical medical staff when working. It can block germs, harmful ultrafine dust, etc. It is used to protect the safety of medical staff and is an important material for epidemic prevention and control. Since the beginning of this year, the Municipal Market Supervision Bureau has been determined to be a good “waiter” and assisted Guangdong Runtaijian Medical Equipment Co., Ltd. (“Runtaijian Company” for short) to successfully obtain medical disposable protective clothing (sterile and non-sterile) in May. (provided by bacteria) medical device registration certificate, becoming the first enterprise in our city and the twelfth enterprise in the province with the qualification to produce sterile medical disposable protective clothing, achieving a zero breakthrough among Zhongshan City’s sterile medical disposable protective clothing manufacturers.
Quick approval
Filling the gap in the production of medical protective clothing in our city
Achieving localized production of medical protective clothing is an important task for Zhongshan City to ensure epidemic prevention supplies, and is included in the 2021 Zhongshan Municipal Government Work Report. In order to fill the gap in the localized production of medical protective clothing in Zhongshan City, the Municipal Market Supervision Bureau focused on pain points such as unfamiliar registration procedures and insufficiently optimized production processes for enterprises switching to production of anti-epidemic materials. With the determination to be a good “waiter”, it intervened in advance, tracked and provided assistance throughout the process. Provide guidance and carry out “full-chain precision assistance” work for key epidemic prevention enterprises that have switched production to do practical things for the enterprises.
The medical protective clothing project has a long registration period from project establishment to the registration certificate, and the regular application time is at least one and a half years. In order to assist companies to successfully obtain the registration certificate as soon as possible, the Municipal Market Supervision Bureau maintains cooperation with the Provincial Food and Drug Administration The relevant business offices communicated with the Provincial Medical DeviceQuality Supervision and Inspection Institute to obtain priority channels for registration inspection, registration declaration and registration quality system verification of project declaration. Let the product registration inspection cycle be shortened by at least half a year. In May 2021, Runtaijian Company obtained the registration certificate within less than a month after accepting the quality system verification work, becoming the first enterprise in our city and the twelfth enterprise in the province with the qualification to produce sterile medical protective clothing, setting a new record in the world. The provincial epidemic prevention and control normalization review and approval is the fastest, and the entire product registration cycle has been shortened by nearly a year, giving companies a head start in product launches and filling the city’s vacancy in the supply of medical protective clothing.
Respond when necessary
Full-process one-stop service enterprise
The reason why Runtaijian Company obtained the registration certificate so quickly is due to the one-stop service provided by the Municipal Market Supervision Bureau. In September 2020, after receiving Runtaijian Company’s application for a registration certificate project for medical protective clothing, the Municipal Market Supervision and Administration Bureau immediately sent business backbones to the company to conduct research and docking, preparing for the company’s production, registration inspection, and quality system The verification provides professional guidance and suggestions, clarifies the registration process and steps, gives companies reassurance when starting protective clothing projects, and dispels their concerns and worries.
Medical protective clothing belongs to the second category of medical devices and is highly professional and technical. The speed of the registration cycle is determined by the company’s readiness. From project establishment, product design and development, process verification, production inspection site and production inspection equipment configuration, sample registration inspection, registration application and registration quality system verification, etc., they are all linked together, and no mistakes can be made in every link. In order to support the implementation of the registration certificate for medical protective clothing of Runtaijian Company, the Municipal Market Supervision Bureau established a special working group to decentralize the assistance work, straighten out the “mess” that the company had no way to start with, and guide the company in the production and inspection workshops Layout design and construction work, material selection and process optimization, preliminary review of registration information, standardize its document management, procurement control, design and development, production process, quality control and handling of unqualified products one by one, providing key positions for the company’s personnel Provide professional guidance to ensure the effective operation of the quality management system until it successfully passes the on-site inspection of the registration quality system organized by the Provincial Food and Drug Administration.
The investment cost of medical protective clothing is high, and the key to affecting product quality lies in the fabric. Therefore, finding qualified fabrics has become the key to the smooth start of the medical disposable protective clothing project. In order to find qualified fabrics as soon as possible, the Municipal Market Supervision Bureau actively assists companies in collecting effective purchasing information for protective clothing fabrics, and provides fabric supplier information of companies that have obtained medical protective clothing registration certificates to companies. The companies will then compare fabrics from different manufacturers according to medical Select protective clothing products based on technical requirements and independently determine fabric suppliers. At the same time, experts from the Provincial Institute of Medical Device Quality Supervision and grassroots medical staff from medical institutions are invited to accurately provide accurate guidance, provide opinions and suggestions on fabrics and design styles, analyze items that do not meet the standards during trial production sample inspection, and propose corresponding rectification plans to ensure product quality. Safe and effective.
In the next step, the Municipal Market Supervision Bureau will take a new attitude of “changing its style, starting again, and opening a new situation” to innovate supervision ideas, improve service levels, and promote the high-quality development of medical devices in Zhongshan City with the fastest speed Speed, use the best services, focus on corporate needs, serve the city’s key medical device projects and innovative development of key enterprises, go all out to support and serve the development of enterprises, and promote the comprehensive and high-quality development of the medical device industry.
Stabilize business and stabilize business again��发
“Enterprise Intellectual Property Rights Protection Mobile Studio” is activated
On November 22, we learned from the Municipal Market Supervision Bureau that Zhongshan Municipal Market Supervision Bureau’s Enterprise Intellectual Property Protection Mobile Studio No. 001 (hereinafter referred to as: Studio) has officially settled in Guangdong Tongyu Communications Co., Ltd., which will help enterprises Establish and improve the intellectual property management system, with the purpose of promoting corporate technological innovation, protecting corporate core intellectual property rights, and improving corporate market competitiveness, enhance corporate intellectual property management capabilities, strengthen corporate intellectual property protection awareness, and enhance corporate intellectual property comprehensive strength, thereby Promote the improvement of Zhongshan’s industrial innovation capabilities.
It is understood that Gao Peipeng, director of the Municipal Market Supervision Bureau, recently led a team to Guangdong Tongyu Communications Co., Ltd. for on-site investigation to gain an in-depth understanding of the company’s difficulties in intellectual property management, and hosted a high-quality development seminar to clarify the requirements for the company’s establishment “Intellectual Property Protection Mobile Studio” and set up a special class, with the director as the team leader, the leader in charge and co-management as the deputy team leader, the Intellectual Property Protection Section, the Intellectual Property Promotion Section, the Price Supervision and Inspection and Anti-Unfair Competition Section, The heads of the Law Enforcement Supervision Section and relevant law enforcement sections serve as members to coordinate and promote this work.
This work is divided into three stages. The first stage (November 2021) is the bottom-up stage, which focuses on understanding the creation, protection, and management of intellectual property rights of listed companies and other key enterprises. The second phase (November 2021-June 2022) targets key enterprises with key support, gathers policy, funding, law enforcement, service and other resources and professional team strength, focuses on solving the intellectual property problems currently faced by enterprises, and helps enterprises Establish and improve the entire chain protection system for intellectual property rights and form typical cases. The third phase (June-December 2022) combines the typical case practices of key supported enterprises and based on the actual needs of the enterprise, promotes and replicates the “Enterprise Intellectual Property Protection Mobile Studio” special service to other key enterprises to help enterprises establish and improve knowledge The property rights management system strengthens corporate intellectual property protection awareness and enhances corporate innovation and creativity capabilities.
According to reports, the “Enterprise Intellectual Property Protection Mobile Studio” will focus on three aspects: the construction of an intellectual property management system, the cultivation and layout of high-value intellectual property rights, and rapid intellectual property rights protection services. In terms of the construction of intellectual property management systems, support key enterprises in formulating corporate intellectual property management systems and development plans, strengthen the full-chain protection mechanism for procurement, R&D and design, production and processing, marketing, after-sales services and other links, and improve the internal intellectual property management of enterprises. system. At the same time, key enterprises are supported to carry out patent analysis and evaluation, study and determine infringement risks, and formulate response plans. In addition, we help key enterprises establish and improve trade secret protection systems and risk prevention and control systems such as employee due diligence and technology source rationality investigations, establish and improve the confidentiality system of internal operating secrets and technical secrets, and effectively reduce corporate trade secret risks.
In terms of cultivating and laying out high-value intellectual property rights, support key enterprises in building high-value patent cultivation and layout centers, formulate intellectual property layout plans, and strengthen the creation and reserve of intellectual property rights in key areas and core technologies. At the same time, enterprises are encouraged to establish a patent navigation enterprise development working mechanism, guide enterprises to use patent information search and analysis, carry out high-quality patent mining and layout, form an intellectual property portfolio that supports the enterprise’s main business income and future development needs, and improve the enterprise’s knowledge of its own The ability of intellectual property products and major competitors to monitor intellectual property infringement risks.
In terms of rapid intellectual property rights protection services, the “Intellectual Property Protection Mobile Studio” provides enterprises with a dedicated service channel for intellectual property rights protection assistance, provides enterprises with professional guidance on intellectual property protection, and helps enterprises quickly resolve patent disputes in the early stages. Respond effectively to avoid undue losses. At the same time, the investigation and handling period for patent administrative enforcement cases involving key enterprises will be shortened within the scope permitted by law.
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