Expert Q&A – Page 3 – media

【EXPERT Q&A】When a buyer asks, “Can it be imported into our country?”, how should the supplier respond?

Drugdu.com expert’s response: In medical device foreign trade communication, many buyers do not ask for prices right away. Instead, they frequently raise questions like: “Can this product be imported into our country?” or “Do you have documents for our market?” Quite a few suppliers simply reply: “Yes, we can export.” This statement is not incorrect, but it fails to provide sufficient information for buyers. When a buyer asks “whether the product can be imported”, they do not merely want to confirm if the supplier has export experience. What they care more about are potential issues the product may encounter when entering the local market, including registration, certification, customs clearance, labeling, instructions for use, after-sales services and other related aspects. If a supplier only replies “we can export”, the buyer will have to ask numerous follow-up questions. Once the communication process becomes overly lengthy, the buyer is very likely to turn to other suppliers ...
- Source: drugdu
- 116
- July 24, 2026
【EXPERT Q&A】What are the core requirements for manufacturers’ QMS under the EU MDR regulation?

Drugdu.com expert’s response: Under the EU MDR, the quality management system requirements for manufacturers are not limited to “production process compliance.” Manufacturers are expected to establish a quality management system that covers the full lifecycle of medical devices. In simple terms, the QMS should demonstrate that the product remains under continuous control from design and development, production and release, through to post-market feedback and risk control. The key requirements can be summarized in five areas: 1. Establish a quality management system that meets MDR requirements Manufacturers need to establish, implement, maintain and continuously improve their QMS. The system should cover processes such as product design and development, production, inspection, release, supplier management, document control, change control, nonconforming product handling, CAPA, internal audits and management review. 2. Include regulatory compliance in the QMS The QMS should clearly define product classification, conformity assessment routes, applicable standards, evidence of compliance with the General ...
- Source: drugdu
- 134
- July 22, 2026
【EXPERT Q&A】How are medical devices classified and managed?

Drugdu.com expert’s response: Medical devices are classified and managed into three categories ‌in ascending order of risk level‌, with the Rules for the Classification of Medical Devices as the core basis. 1. Management Classification of Three Categories of Medical Devices ‌Class I‌: Medical devices with low risk, whose safety and effectiveness can be ensured through routine management, such as ordinary medical surgical masks and medical examination gloves. ‌Class II‌: Medical devices with moderate risk that require strict control and management to ensure safety and effectiveness, such as clinical thermometers and non-invasive monitors. ‌Class III‌: Medical devices with relatively high risk that need particularly strict control measures to ensure safety and effectiveness, such as implantable cardiac pacemakers and artificial joints. 2. Supporting Classification Management Rules In addition to the risk classification of the products themselves, China also implements classified and hierarchical supervision for the production and operation links, clarifying the responsibilities of regulatory ...
- Source: drugdu
- 108
- July 20, 2026
【EXPERT Q&A】The product has page views, but why are there still no inquiries?

Drugdu.com expert’s response: Recently, some suppliers have raised a very practical question: “My products already have views. Why are there still no buyer inquiries?” This is quite common for medical device products. When medical device buyers browse products on a platform, they usually do not send an inquiry immediately after seeing one product. They first make a judgment: Is this the product I am looking for? Is this company reliable? Can the certificates and documents support my target market? Will communication with this supplier be complicated? So, having views does not mean inquiries will come right away. Views show that the product has received a certain level of exposure. But whether buyers are willing to make further contact depends on whether the product page and company information can support their sourcing decision. 1. Buyers saw the product, but did not see a clear reason to contact you For many product ...
- Source: drugdu
- 127
- July 20, 2026
【EXPERT Q&A】Why Do Medical Device Products Get Views but No Inquiries?

Drugdu.com expert’s response: Recently, some suppliers have raised a very practical question: “My products already have views. Why are there still no buyer inquiries?” This is quite common for medical device products. When medical device buyers browse products on a platform, they usually do not send an inquiry immediately after seeing one product. They first make a judgment: Is this the product I am looking for? Is this company reliable? Can the certificates and documents support my target market? Will communication with this supplier be complicated? So, having views does not mean inquiries will come right away. Views show that the product has received a certain level of exposure. But whether buyers are willing to make further contact depends on whether the product page and company information can support their sourcing decision. 1. Buyers saw the product, but did not see a clear reason to contact you For many product ...
- Source: drugdu
- 120
- July 15, 2026
【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
- 131
- 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
- 137
- 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
- 134
- 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
- 130
- 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
- 137
- July 3, 2026

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