media – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】Before exporting medical devices, first sort out these “easily ambiguous” issues

Drugdu.com expert’s response: Medical devices are a highly regulated product category worldwide. In foreign trade communication, customs clearance, and overseas regulatory inspections, many vaguely expressed, inconsistent, or unsupported details can easily lead to repeated inquiries from buyers, cargo detention, and order delays. Many suppliers only briefly inform customers that “all certificates are complete and compliant” without sorting out industry-specific controversial points in advance, resulting in repetitive and inefficient communication.I. Qualification Certificates: Complete in Name but Mismatched in Details (Most Frequently Questioned) This is the most frequently questioned area by customers. Many companies only generally claim to have “a full set of certificates,” yet suffer from inconsistent information, ambiguous scope of application, and unclear validity periods. Domestic Qualification Matching Common ambiguities: Whether the model, production address, and product scope on the Class I/II/III medical device registration/filing certificate, production license, and export sales certificate are fully consistent; whether a compliant export ...
- Source: drugdu
- 38
- July 13, 2026
【EXPERT Q&A】Why Do Buyers Keep Asking Questions Even After You Say “All Certificates Are Complete”?

Drugdu.com expert’s response: In daily sales and procurement communication, many suppliers share a common confusion: even after clearly telling buyers that “all certificates are complete and qualifications are formal,” the other party still keeps asking questions and repeatedly requests various supporting documents. Many people assume that the buyer is distrustful or deliberately being difficult, but this is not the case. Such behavior is not personal; it is an inevitable result of risk control, compliance requirements, process standards, and trust-building in the procurement process, with very practical and reasonable underlying logic. First and foremost, the buyer’s core concern is the authenticity and validity of the certificates. The current market environment is complex, and cases of forged certificates, misappropriated certificates, expired qualifications, and use beyond authorized scope are not uncommon. Especially in highly regulated industries such as pharmaceuticals, chemicals, food, building materials, and import/export, one non-compliant qualification can lead to seizure of ...
- Source: drugdu
- 48
- July 10, 2026
【Company Recommendation】Shanghai Wantewant Technology Co., Ltd

Company Profile We are a high-tech enterprise oriented towards research and development, specializing in the fields of pharmaceutical raw materials, intermediates, peptide components, cosmetic raw materials, and nutritional supplement raw materials. We offer standardized large-scale production services and conduct global wholesale business. Our multiple peptide raw materials possess core physiological effects such as weight loss, muscle building, blood sugar reduction, and anti-aging, are widely applicable to the research and production demands in the pharmaceutical, beauty, and health care sectors. We adopt strict batch production standards and have sufficient production capacity and stable supply capabilities. All products have been professionally tested by third-party institutions and come with complete test reports and qualification certificates, ensuring stable batch quality and complete traceability. For large-scale orders, we offer competitive wholesale prices. We uphold the core values of integrity, pragmatism, innovation and development, and continuously enhance our technical strength and product quality. Product Introduction We ...
- Source: drugdu
- 61
- July 10, 2026
Ascletis Pharma submits Investigational New Drug (IND) applications to the FDA for two new obesity drugs

Recently, Ascletis Pharma announced that it has recently submitted two Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA): ASC36, a next-generation peptide amylin receptor agonist administered once monthly to quarterly, and ASC36_35FDC, a once-monthly injectable combination of ASC36 and the peptide GLP-1R/GIPR agonist ASC35, for the treatment of obesity. According to relevant data, the overweight rate among adults in my country is about 34.3%, and the obesity rate is about 16.4%; the overweight rate among children and adolescents aged 6 to 17 is 11.1%, and the obesity rate is 7.9%, indicating that the overall situation is still not optimistic. https://mp.weixin.qq.com/s/Vt-YLF5ncLZAxzwrngG75A
- Source: drugdu
- 62
- July 9, 2026
Fengtou News | Highlight Pharmaceuticals’ Ganoxitinib Receives Breakthrough Therapy Designation from CDE

Today, Glorious Pharmaceuticals announced that its independently developed oral highly selective JAK1/TYK2 dual inhibitor, ganoxitinib (TLL-018), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration for the treatment of rheumatoid arthritis (RA). This designation is based on positive topline data from the Ganoxitinib Phase III Registration Study (TARA). The CDE (Center for Drug Evaluation) has determined that Ganoxitinib meets the criteria for breakthrough therapy, indicating its use in the prevention and treatment of life-threatening or quality-of-life diseases, and demonstrating a more significant or important therapeutic effect compared to existing treatments. The TARA study is the world’s first Phase III clinical trial of RA using the marketed JAK inhibitor Shangjie® (tofacitinib) as a positive control and achieving the superiority endpoint. Data showed that ganoxitinib was significantly superior to tofacitinib in both the primary endpoint and all secondary efficacy endpoints (p ...
- Source: drugdu
- 61
- July 9, 2026
MEDICALL EXPO

Organiser：Messe Düsseldorf GmbH, Germany Time：July 24th – July 26th, 2026 Address：Chennai Trade Centre, Chennai, INDIA Exhibition hall：Chennai Trade Centre Product range: Medical Technology/Electronic Medical Products, Equipment and Systems Zone Diagnostics and Imaging Products, Equipment and Systems Zone Portable Physiotherapy and Orthopedic Products, Equipment and Systems Zone Surgical Products, Equipment and Systems Zone Hygiene and Disinfection Products, Disposable Consumables Zone Rehabilitation Devices and Equipment Zone About MEDICALL EXPO： MEDICALL EXPO is one of the most professional medical equipment exhibitions in India and South Asia. Organized by Messe Düsseldorf GmbH, it serves as a pivotal trade event for India’s hospital and medical device industries. The previous edition covered a total area of 25,000 square meters, with 750 participating enterprises from China, the United States, the United Kingdom, Germany, Japan, South Korea, Thailand, Malaysia, Chinese Taiwan, Australia, Singapore and other regions, attracting 23,000 attendees. It enables participants to connect with global ...
- Source: drugdu
- 51
- July 9, 2026
【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
- 56
- 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
- 57
- 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
- 62
- 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
- 67
- July 3, 2026

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.