On September 29, the Dongguan Workstation for Drug and Medical Device Registration Guidance Services under the Evaluation & Inspection Center of Guangdong Medical Products Administration (“the Dongguan Workstation”) was officially inaugurated.
This marks the establishment of a new registration guidance service platform in Dongguan, dedicated to providing local pharmaceutical and medical device enterprises with pre-registration guidance, policy consultation, technical Q&A, and communication channels with the provincial review and certification center. The new platform aims to tackle the pain points and bottlenecks enterprises face during the registration process, reducing registration costs and shortening the time-to-market cycle for new products.
The Dongguan Workstation for Drug and Medical Device Registration Guidance Services is officially unveiled.
The Dongguan Workstation, jointly established by the Guangdong Medical Products Administration (“GDMPA”) and the Dongguan Municipal People’s Government, is operated by the Dongguan Institute for Food and Drug Control.
According to Qiu Nan, Deputy Director of the GDMPA, Dongguan’s pharmaceutical industry spans multiple sectors including traditional Chinese medicine, chemical pharmaceuticals, biopharmaceuticals, and medical devices, forming a comprehensive ecosystem that integrates traditional medicine with modern biotechnology. The sector, he noted, is demonstrating strong growth momentum.
The establishment of the Dongguan Workstation represents a strategic step in implementing national and provincial directives from the CPC Central Committee, the State Council, and the Guangdong Provincial People’s Government to promote the high-quality development of the biopharmaceutical industry. The Dongguan Workstation will introduce three key innovations, advance review services, localized technical guidance, and innovation resource integration. Together, these mechanisms will create a full-chain service system covering R&D transformation, registration and approval, and post-market supervision.
“With this new workstation, we can now access professional registration guidance right at our doorstep”, said Yu Zhiyang, Registration Director of Guangdong Fapon Biotech Co., Ltd. He noted that the new service platform will effectively address long registration cycles and the challenges of aligning with review standards. “In the past, we had to travel to the provincial or even national administration to file for product registration”, Yu explained. “Now, both transportation and communication costs are significantly reduced. Moreover, the workstation’s pre-consultation and technical guidance services greatly stimulate innovation among pharmaceutical enterprises.”
Deputy Director Qiu Nan stated that the GDMPA will continue to deepen coordination with the Dongguan Municipal People’s Government to jointly advance the city’s high-quality biopharmaceutical development. He expressed hopes that Dongguan will seize this opportunity to leverage its advanced manufacturing clusters, further promote industry-university-research collaboration, and nurture a group of biopharmaceutical enterprises with strong core competitiveness. Ultimately, Dongguan aims to become a benchmark city for the biopharmaceutical industry in the Guangdong-Hong Kong-Macao Greater Bay Area, contributing to Guangdong’s goal of building a globally influential hub for bio-pharmaceutical innovation.
Why Songshan Lake was chosen as the workstation’s home?
The biopharmaceutical industry has become a key track in the new wave of technological revolution and industrial transformation. Recognizing this trend early on, Dongguan has identified biopharmaceuticals as one of its strategic emerging industries, giving it focused policy and resource support.
So why was the Dongguan Workstation for Drug and Medical Device Registration Guidance Services established in Songshan Lake?
According to Feng Bin, Deputy Secretary-General of the Dongguan Municipal People’s Government, the city’s biopharmaceutical sector is enjoying strong growth momentum, bringing together a number of leading enterprises in specialized fields, including Zhongsheng Pharma, HEC, 3SBio, Fapon Biotech, BrosMed Medical, and Modern Dental. As the core area of Dongguan’s biopharmaceutical landscape, Songshan Lake has attracted numerous well-known domestic and international enterprises and innovation teams. With just one-quarter of the city’s total industrial footprint, Songshan Lake concentrates 80% of Dongguan’s innovation resources, forming a complete value chain from research and development to commercialization. It has become a key growth pole on the biopharmaceutical innovation map of the Guangdong-Hong Kong-Macao Greater Bay Area.
Feng Bin noted that the establishment of the Dongguan Workstation in Songshan Lake will serve as a bridge and link between the GDMPA and the Dongguan Municipal People’s Government, facilitating deeper collaboration to jointly drive the development of Dongguan’s biopharmaceutical industry. The Dongguan Workstation will also become a crucial engine and driving force for the city’s biopharmaceutical sector to accelerate its rise and move up the value chain.
Looking ahead, Dongguan will adhere to high standards and rigorous requirements in building and operating the workstation. The city plans to further consolidate innovation resources, make full use of the existing biopharmaceutical innovation assets and high-level sci-tech platforms within Songshan Lake High-tech Industrial Development Zone, and build a recognizable service brand for the workstation. By providing cutting-edge technological support for enterprise innovation, Dongguan aims to attract more biopharmaceutical companies to establish a presence in the city.
/Learn More/
Dongguan Workstation for Drug and Medical Device Registration Guidance Services
[Service Scope]
The workstation serves all pharmaceutical (including chemical drugs, traditional Chinese medicine, and biological products) and medical device (covering Category I filing, Category II/III registration) enterprises, R&D institutions, and research organizations in Dongguan.
[Core Services]
Pre-registration guidance, policy interpretation and training, communication and coordination with regulatory authorities, and talent cultivation
[Service Procedure]
Request submission: Enterprises may submit the Drug and Medical Device Registration Service Request Form either in person at the workstation or online via email (Dgshiyaojian@163.com) or phone (0769-22603887). The form should specify product type, registration stage, and specific issues requiring guidance.
Request evaluation: The workstation will respond within three (3) working days, forwarding the case to technical staff from the Dongguan Institute for Food and Drug Control or experts from the GDMPA based on classification.
Guidance implementation: Solutions will be provided through document pre-reviews, expert consultations, and mock evaluations, offering targeted professional advice.
Feedback delivery: Formal guidance will be provided to enterprises within 5-10 working days (or up to 15 working days for complex cases).
[Contact Information]
Address: 4/F, Dongguan Institute for Food and Drug Control, No. 7 Huangqi Street, Changyuan Road, Songshan Lake High-tech Industrial Development Zone, Dongguan City
Contact Person: LIU PEI (Dedicated Workstation Staff) Phone: 0769-22603887
Email: Dgshiyaojian@163.com
Working Hours: Monday to Friday, 9:00-12:00 / 13:30–17:00
Written by: Feng Huan Photo by: Zheng Jiaxiong Edited by: Wang Baoguang
