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【EXPERT Q&A】What are the requirements for the content of the domestic registration application materials for medical devices?

Drugdu.com expert’s response: Regarding the domestic registration and application materials for medical devices in China, the content requirements are as follows: Currently, the requirements for domestic medical device registration and application materials are mainly based on the Requirements and Instructions for Medical Device Registration Application Materials issued by the National Medical Products Administration (NMPA). These requirements came into effect on January 1, 2022, and the previous 2014 version was repealed simultaneously. In addition, the Measures for the Administration of Medical Device Registration and Filing clearly stipulates that applications for registration or filing shall submit materials in accordance with the relevant requirements of the NMPA, and applicants and filers shall be responsible for the authenticity of the materials. The domestic registration and application materials for medical devices mainly consist of 6 major parts: ‌Regulatory Information‌ This section mainly proves “who is applying, what is being applied for, and what is the basis for the application”. ...
- Source: drugdu
- 64
- July 8, 2026
The General Practice Conference & Exhibition (GPCE)

Organiser：Reed Exhibitions Australia Pty Ltd Time：July 31 – August 2, 2026 Address：2 Clarendon Street, Southbank, Melbourne, Victoria, Australia, 3205, Australia Exhibition hall：Melbourne Exhibition & Convention Centre Product range: ‌Testing Equipment: Blood pressure monitors, blood glucose meters, digital thermometers, oximeters, blood test analyzers, various testing reagents, cardiovascular detectors, blood lipid analyzers, stethoscopes, sperm quality testers, contraceptive devices, home ECG monitors, health detectors, pedometers and other home testing devices Health Products: Various small health appliances; functional health textiles with healthcare properties (nano, magnetic therapy, far-infrared, negative ion, tourmaline, bamboo charcoal), sleep products, bedding, apparel, protective gear, accessories, sauna series; nano-electrolytic multi-functional water dispensers, ion water machines, direct drinking water dispensers, central water purification equipment, nano-ecological antibacterial cups, water treatment environmental protection series; functional health activation cups, energy cups, health preservation cups and other health care products Care Equipment: Various rehabilitation care equipment, accessibility equipment, mobility aids, hearing and speech assistive devices, ...
- Source: drugdu
- 80
- July 7, 2026
【EXPERT Q&A】What “File Details” Do Medical Device Suppliers Most Often Overlook Before Export?

Drugdu.com expert’s response: Before exporting medical devices, suppliers often overlook file details related to compliance, information consistency, and local market adaptation. These issues can easily lead to customs delays, registration setbacks, or rejected applications. Common problems include: 1. Failing to match the correct type of export certificate Different intended uses may require different FDA export certificates. For example, devices intended for clinical research may require a Certificate of Exportability under Section 802, while devices intended for further processing may only require a simple notification. Some companies mistakenly use a general Certificate to Foreign Government (CFG), which may not meet the regulatory requirements of the target market. 2. Missing special documents for unregistered products When exporting unregistered medical devices to markets such as Singapore, companies may need to apply for approval under a Special Access Route (SAR) in advance. They must also keep complete traceability records as distribution evidence. Many suppliers ...
- Source: drugdu
- 68
- July 6, 2026
【EXPERT Q&A】Why does incomplete drug registration information affect the advancement of overseas cooperation?

Drugdu.com expert’s response: Incomplete drug registration documents will directly hinder the advancement of overseas cooperation from multiple core dimensions, and the specific reasons are as follows: ‌I. Failure to pass overseas access reviews‌ Overseas drug regulatory authorities (such as the US FDA and EU EMA) have strict requirements for the completeness and traceability of registration documents. Missing key documents will directly lead to the rejection of the registration application, making the product unable to enter the target market, and the foundation for cooperation will be completely invalidated. ‌II. Reduced trust of overseas partners‌ In the access review process of overseas purchasers/partners, complete registration documents are the core basis for proving an enterprise’s compliance capability and product quality stability. Incomplete documents will prevent the other party from completing internal compliance approval, and directly terminate the cooperation promotion process. I‌II. Significantly increased additional compliance costs‌ After missing documents, enterprises need to urgently ...
- Source: drugdu
- 72
- July 3, 2026
Vietnam Medipharm Expo

Organiser：Ministry of Health of Vietnam Time：July 30 – August 1, 2026 Address：Lawrence S. Ting Building, 801 Nguyen Van Linh Parkway, District 7, Ho Chi Minh City, Vietnam Exhibition hall： Saigon Exhibition and Convention Center (SECC) Product range: ‌Medical Products‌: Medical equipment and instruments, medical consumables, medical dressings, surgical equipment, ambulance equipment, diagnostic equipment and supplies, ophthalmic instruments and equipment, otolaryngology equipment, dental equipment and supplies, medical reagents and equipment, healthcare products and devices, medical institution and laboratory technical equipment, medical information and technical exchange, aesthetic instruments. ‌Analytical Instruments‌: Optical analytical instruments, mass spectrometers, spectrometers, chromatographs, spectrometers, electrochemical analytical instruments, ray analytical instruments, gas chromatographs, liquid chromatographs, thermal analytical instruments, various portable instruments, surface analytical instruments, nuclear analytical instruments, elemental analytical instruments, process analytical instruments, component analytical instruments, injection analytical instruments and other general analytical instruments. ‌Laboratory Equipment‌: Laboratory instruments and equipment, laboratory automation and accessories, optical instrument equipment, microscopes, optical ...
- Source: drugdu
- 81
- July 2, 2026
【EXPERT Q&A】Compliance Information to Be Displayed on Medical Device Product Pages

Drugdu.com expert’s response: In accordance with the Quality Management Specifications for Online Sales of Medical Devices which came into effect on October 1, 2025 and relevant regulatory requirements, the following compliance information must be continuously displayed in a prominent position on the medical device product page: ‌Core Product Qualification Information‌ Images of the Medical Device Registration Certificate (for Class II and Class III devices) or the Class I Medical Device Filing Information Form, or the link identifier of the corresponding electronic certificate. ‌General Warning Information‌ For all medical devices sold online in retail mode, the warning statement “Please carefully read the product manual before purchase and use, or purchase and use it under the guidance of medical personnel” must be displayed. ‌Exclusive Warnings for Special Categories‌ For selling contact lenses (contact lenses): The mandatory warning statement “Wearing this product must be fitted by an optometry professional” must be displayed. For selling hearing aids: The mandatory warning statement “Before fitting a ...
- Source: drugdu
- 68
- July 1, 2026
AACC – Clinical Lab Expo

Organiser：American Association for Clinical Chemistry Time： July 28–30, 2026 Address：2301 S. Lake Shore Drive Chicago, Illinois 60616 USA Exhibition hall：McCormick Place Product range: In Vitro Diagnostic (IVD) Instruments & Reagents, biochemical instruments, chemical reagents, chromatographs, food safety detectors, amino acid sequencers, DNA synthesizers, microplate readers, fermentation equipment, extraction equipment, separation equipment, purification equipment, biopharmaceutical instruments & consumables, diagnostic instruments, pharmaceuticals and diagnostics, electronic and optical microscopes, spectrometers, spectrum analyzers, X-ray analytical instruments, injection analytical instruments, electrolytes, cancer testing, blood glucose testing, DNA analysis, enzymology, molecular diagnostics, hematology and hemostasis, cardiology testing, infectious disease testing, medical genomics, informatics, etc. About AACC – Clinical Lab Expo： AACC – Clinical Lab Expo, also known as the American Clinical Laboratory & In Vitro Diagnostic Exhibition, is the world’s largest and most influential annual scientific conference and clinical laboratory event. It offers attendees opportunities to connect with global leaders in clinical chemistry, molecular diagnostics, ...
- Source: drugdu
- 82
- June 30, 2026
【EXPERT Q&A】Why Do Class III Medical Device Buyers Pay More Attention to Compliance Documents?

Drugdu.com expert’s response: In medical device procurement, communication around Class III products often takes longer than for Class I or Class II products. Many suppliers may feel that buyers are asking “too many details”: registration certificates, production licenses, ISO certificates, CE/FDA documentation, test reports, clinical data, authorization letters, quality system documents, after-sales service plans… Sometimes, the full set of documents has not even been provided before pricing discussions begin. But for Class III medical device buyers, compliance documents are not an extra requirement. They are the first threshold in procurement evaluation. According to China’s Regulations on the Supervision and Administration of Medical Devices, Class III medical devices refer to products with higher risks that require special measures for strict control and management to ensure their safety and effectiveness. Risk classification takes into account factors such as intended use, structural characteristics, and method of use. In other words, Class III products ...
- Source: drugdu
- 72
- June 29, 2026
【Company Recommendation】Emeishan Hongsen Biopharmaceutical Co., Ltd.

Company Introduction Emeishan Hongsen Biopharmaceutical Co., Ltd. is a national high-tech enterprise focusing on peptide fragments, protected amino acids, pharmaceutical intermediates, APIs, and CMO/CDMO fields. Business scope: an experienced project undertaking team escorts full life-cycle CMO/CDMO services; a GMP quality system that has been audited many times by domestic and foreign customers; the company has an independent technology R&D center, a provincial enterprise technology center, and Leshan Synthetic Biology Engineering Technology Research Center, providing one-stop services including process optimization, R&D, production, and sales. The company was established on February 18, 2011. It currently has more than 150 employees and more than 70 sets of various reactors ranging from 100L to 6300L, providing flexible and diversified cooperation models. Star Products 89030-95-5 Copper Peptide Copper peptide can effectively stimulate the biosynthesis of collagen in fibroblasts, thereby promoting rapid wound healing. It can also effectively block the neurotransmission of acetylcholine substances, thereby relaxing ...
- Source: drugdu
- 125
- June 26, 2026
China’s first ADC (Advanced Dioxide Doppler) to be submitted for market approval

On June 23, the CDE (Center for Drug Evaluation) website showed that Chia Tai Tianqing Pharmaceutical Group’s application for marketing authorization of vetectobactimab for injection was accepted. This monotherapy is indicated for patients with CLDN18.2-positive, locally advanced, or metastatic gastric/gastroesophageal junction adenocarcinoma who have received at least two lines of prior systemic therapy . Previously, this drug had been formally included in the CDE’s priority review and approval process . Screenshot source: CDE official website Vitacotobactam (development code: LM-302 ) is an antibody-drug conjugate (ADC) targeting Claudin18.2 (CLDN18.2) developed by Lixin Pharmaceuticals. It specifically binds to CLDN18.2-positive tumor cells, enters the cells via endocytosis, and releases small molecule toxins to achieve precise killing of tumor cells. In July 2025, China Biopharmaceutical announced that it would acquire 100% of Lixin Pharmaceutical Technology (Shanghai) Co., Ltd. for a net consideration of approximately US$500 million , bringing the latter’s highly regarded bispecific antibody ...
- Source: drugdu
- 126
- June 25, 2026

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