Expert Q&A – media

【EXPERT Q&A】What is the domestic medical device registration (NMPA) process like?

Drugdu.com expert’s response: The domestic NMPA registration process for medical devices adopts three differentiated procedures based on the product risk level, as detailed below: I. Pre-procedure for Classification Definition First, clarify the risk category of the product: Class I medical devices are subject to ‌filing management‌, while Class II and Class III medical devices are subject to ‌registration management‌. If the product attributes are ambiguous, you may first apply to the drug regulatory authority for classification definition, and initiate subsequent registration procedures only after obtaining a clear category determination result. II. Core Procedures for Classification-based Registration ‌Class I Medical Device Filing‌: Prepare documents including product technical requirements, safety risk analysis, and production system-related materials, and submit the filing application to the municipal drug regulatory authority. A filing certificate can be obtained quickly if the documents are compliant, with no clinical trials required. ‌Class II Medical Device Registration‌: Complete R&D and ...
- Source: drugdu
- 30
- August 3, 2026
【EXPERT Q&A】What are the requirements for the approval of medical device qualifications?

Drugdu.com expert’s response: I. Basic Eligibility for Applicants To apply for medical device export qualification approval in China, the applicant must be a domestic medical device registrant, filing entity, or a manufacturer that has obtained the Medical Device Production License or completed production filing. Its registered business address must fall within the administrative jurisdiction of the approving authority. Applications will be rejected if the enterprise is under ordered rectification for production suspension, included in the serious illegal and dishonest list, or the relevant product is under ongoing investigation. II. Document Requirements for Two Types of Export Qualifications For medical devices that have completed registration or filing in China, the required documents include the corresponding Medical Device Registration Certificate or product filing record, the supporting Medical Device Production License or production filing record, and valid documents proving the product’s legal sales status. For export-specific medical devices that have not completed domestic ...
- Source: drugdu
- 50
- July 31, 2026
【EXPERT Q&A】When an overseas buyer sends an inquiry, how should the first sentence be replied to?

Drugdu.com expert’s response: When engaging in pharmaceutical foreign trade, many suppliers encounter this situation: You receive an overseas inquiry. The buyer only writes one sentence: “Please send me your price.” or “We are interested in your product.” Upon seeing the inquiry, many enterprises’ first reaction is to quote immediately. However, after sending the quotation, a common problem arises: the buyer does not follow up. Why? Because in the first round of communication, the supplier and the buyer may focus on different things. What the buyer wants to confirm is: Whether this product meets their needs? Whether the supplier has export experience? Can relevant documents be provided? Is the price suitable for their market? Yet suppliers often only focus on: When will the customer place an order? Therefore, the first response to an overseas inquiry is not just to reply to the customer, but more importantly, to initiate effective communication. I‌. Do not ...
- Source: drugdu
- 61
- July 29, 2026
【EXPERT Q&A】There are many export documents for medical devices. Which information should be placed on the product page in advance?

Drugdu.com expert’s response: When communicating with medical device suppliers, we often encounter a common situation: Enterprises hold CE certification, ISO certificates and can provide relevant supporting documents, but the content displayed on their product pages is overly simplistic. Some pages only include the product name, a few images, plus a few generic lines: “High quality”、“CE available”、“OEM supported” For suppliers, these messages are enough to highlight their product advantages. However, for overseas buyers, after seeing such content, they still cannot judge clearly: Whether this product meets their procurement requirements Whether the supplier has relevant experience in their target market Whether the supplier can cooperate to provide necessary documents for subsequent registration, customs clearance or local sales Medical device procurement differs greatly from ordinary commodity procurement. Before contacting suppliers, buyers usually learn about the enterprise’s capabilities and product details through the product page first. Therefore, it is unnecessary to upload all export-related ...
- Source: drugdu
- 59
- July 27, 2026
【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
- 76
- 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
- 85
- 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
- 77
- 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
- 76
- 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
- 80
- 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
- 93
- July 13, 2026

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