Expert Q&A – media

【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
【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
【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
【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
- 61
- July 1, 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
- 67
- June 29, 2026
【EXPERT Q&A】What certifications are required for medical devices to enter the Saudi market?

Drugdu.com expert’s response: The core of entering the Saudi market is mandatory registration and certification with the Saudi Food and Drug Authority (SFDA), along with a series of supporting requirements. The following breaks them down by priority. I. Core Certification That Must Be Completed: SFDA Medical Device Registration This is the only legal entry requirement for all medical devices. Unregistered products cannot clear customs or be sold. Registration Process: Submit registration application through the SFDA online system (MDMA / Saudi Drug Registration System) Submit complete technical documentation; SFDA conducts document review Medium-to-high risk products may be required to provide additional test reports or undergo on-site audits Upon approval, a registration certificate is issued (typically valid for 5 years, renewable upon expiry) II. Products Classified by Risk Level — Requirements Differ SFDA classifies medical devices into four classes. The higher the class, the stricter the review: Class I (Low Risk) — e.g., surgical blades, ...
- Source: drugdu
- 74
- June 22, 2026
【EXPERT Q&A】How to apply for a medical device business license?

Drugdu.com expert’s response: Obtaining a Medical Device Distribution License — the key is to first clarify which class of devices you intend to distribute, as the process for Class II and Class III is completely different. Clarify: Are you applying for a “License” or “Filing”? Class I (Low Risk) — e.g., surgical scalpels, gauze, stethoscopes: Filing during business registration is sufficient. No license required. Class II (Medium Risk) — e.g., blood pressure monitors, thermometers, nebulizers: File with the municipal drug regulatory authority. This is not called a license. Class III (High Risk) — e.g., cardiac stents, CT scanners, ventilators, contact lenses: You must apply for a Medical Device Distribution License from the municipal drug regulatory authority. When people ask about a “license,” they usually mean Class III. The following covers Class III. Application Requirements (Five Mandatory Criteria — All Must Be Met) Personnel: The quality manager must hold a college degree or higher (or intermediate professional ...
- Source: drugdu
- 86
- June 19, 2026
【EXPERT Q&A】What problems do pharmaceutical companies have in the quality management of drug production?

Drugdu.com expert’s response: Common issues in pharmaceutical production quality management are generally concentrated in the following areas: Personnel & Awareness Quality management in many companies remains at the level of “passing inspections” rather than being truly internalized into production habits. Frontline operators have high turnover, training is superficial, and SOP non-compliance is widespread. The quality department lacks authority and often yields to production when output and quality conflict. Data Integrity This is a key regulatory enforcement focus in recent years. Handwritten records are casually altered, electronic data lacks audit trails, abnormal data is deleted without trace, and shared login accounts are common — especially prevalent among small and mid-sized pharma companies. FDA and NMPA requirements on data integrity are tightening, yet many companies’ IT systems are still stuck at the Excel stage. Deviation & Change Control Out of Control When deviations occur, the first instinct is to find a workaround, ...
- Source: drugdu
- 78
- June 17, 2026

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