Expert Q&A – Page 3 – media

【EXPERT Q&A】How to apply for a medical device registration certificate?

Drugdu.com expert’s response: For medical device registration certificate application, the first step is not to immediately prepare a large stack of materials, but to determine which risk class the product belongs to. In China, medical devices are categorized into Class I, Class II and Class III based on their risk levels. Class I devices are subject to record-filing management, while Class II and Class III devices are subject to registration management. The “medical device registration certificate application” that enterprises usually refer to mainly targets Class II and Class III products. For domestic Class III devices, as well as imported Class II and Class III devices, the National Medical Products Administration (NMPA) is responsible for the review, evaluation and approval. Domestic Class II devices are generally registered under the charge of provincial drug regulatory authorities. After clarifying the product classification, you need to confirm the registration applicant and the production relationship. ...
- Source: drugdu
- 138
- September 23, 2026
【EXPERT Q&A】If the buyer requests COA, GMP and DMF at one time, do all the documents need to be sent?

Drugdu.com expert’s response: When exporting APIs, excipients, and peptide APIs, suppliers often receive inquiries like this. After asking about the product and price, the buyer quickly adds: “Please send COA, GMP and DMF.” Some suppliers may think the buyer is professional and immediately send all the documents they have. Others may be more cautious, worry about sensitive information, and simply reply: “Available.” Neither approach is ideal. When a buyer asks for COA, GMP and DMF at once, it may mean that this is not just a casual price inquiry. The buyer may already be checking whether the product can move forward to purchasing, registration, or supplier qualification. But what documents to send, and how much to share, still depends on the project stage. First, understand why the buyer needs these documents Even when buyers ask for the same documents — COA, GMP and DMF — their purpose may be different. Some buyers ...
- Source: drugdu
- 187
- September 21, 2026
【EXPERT Q&A】A Buyer Asked for Free Samples in the First Inquiry. Should You Send Them Right Away?

Drugdu.com expert’s response: If you’re working in the pharmaceutical or medical device export business, you’ve probably seen inquiries like this: Before discussing pricing or technical details, the buyer simply asks: “Can you provide free samples?” Some suppliers see this as a positive signal. They assume the buyer is ready to evaluate the product and hope that sending samples quickly will increase the chance of winning the order. Others become cautious immediately, worrying that the buyer is only looking for free samples with no real purchasing intention. In reality, both conclusions may be premature. A sample request shows that the buyer is interested enough to evaluate the product, but it doesn’t tell you why they need the sample, what they intend to do with it, or whether a commercial order is likely to follow. Instead of rushing to ship samples, it’s usually more valuable to clarify the buyer’s requirements first. ...
- Source: drugdu
- 167
- September 18, 2026
【EXPERT Q&A】How are in vitro diagnostic kits developed?

Drugdu.com expert’s response: The R&D of in vitro diagnostic kits is a rigorous and standardized full-process system, with 5 core key stages that ultimately produce safe and effective products complying with regulatory requirements. Stage 1: Project Initiation and Preparation Clarify the target analyte to be tested, intended use and application scenarios, and complete research on market capacity, competing products and clinical demands. Confirm technical feasibility through literature review, form the project team, and prepare the project initiation assessment document for review and approval. Define core indicators such as product performance parameters and intended use, complete design input, and form the product summary materials required for registration. Stage 2: Product Development Raw material screening: Select no less than 3 qualified suppliers to ensure the quality of core raw materials (antigens, antibodies, primers, probes, etc.) is stable and traceable. Process and system optimization: Determine key parameters such as reagent formulation ratio, reaction ...
- Source: drugdu
- 126
- September 16, 2026
【EXPERT Q&A】What is the process for applying for a medical device registration certificate?

Drugdu.com expert’s response: The application for a Medical Device Registration Certificate generally does not start with “preparing documents”. Instead, the first step is to confirm exactly which risk class the product belongs to. In China, medical devices are categorized into Class I, Class II and Class III based on their risk levels. Class I devices are subject to record-filing management, while the registration certificate application process is usually required only for Class II and Class III devices. Therefore, before formally launching the application, enterprises must first complete product classification judgment, confirming the product name, structural composition, intended use, working principle and risk level, to avoid taking a wrong path in subsequent tests, clinical evaluation and declaration. After the classification is confirmed, the enterprise needs to clarify the registration applicant and the production arrangement. That is to confirm who acts as the registration applicant, who is responsible for production, whether entrusted ...
- Source: drugdu
- 119
- September 14, 2026
【EXPERT Q&A】How should one apply for a medical device license (Class III)?

Drugdu.com expert’s response: For trading companies and distributors that sell Class III medical devices, it is the Class III Medical Device Business License that they need to apply for. For manufacturers, the required qualifications are the Medical Device Production License and the product-specific Medical Device Registration Certificate, and these two sets of qualifications must not be confused. The general application process for the Class III Medical Device Business License is as follows: Confirm that the product falls into the Class III category: Look up the medical device classification and corresponding classification coding of the target product first. Different products correspond to different business scope entries, and this step will directly affect the subsequent requirements for personnel, business premises and warehousing conditions. Prepare the required operating conditions: The enterprise needs to have a business premises that matches its operating scale, qualified quality management personnel, complete quality management rules and a computer ...
- Source: drugdu
- 122
- September 11, 2026
【EXPERT Q&A】If the buyer only says “Send me your catalog”, should the entire catalog be sent directly?

Drugdu.com expert’s response: When engaging in pharmaceutical foreign trade, you often receive very short inquiries that simply say: “Send me your catalog.” Some buyers only leave their country and email address, with no mention of specific products, purchase quantities, or whether they are importers, distributors or end users. Many suppliers’ first reaction is to send over the company catalog directly. It is a dozens-of-page PDF covering a full product line, complete with images, parameters and company introduction. After sending it, they just wait for the buyer’s reply. But more often than not, there is no follow-up response. It is not that the catalog is completely useless. The problem is that when you send the entire catalog directly, the buyer may not bother to read it carefully. Especially for products like APIs, excipients, medical devices and consumables, buyers rarely go through a catalog “just browsing casually”. They probably already have a ...
- Source: drugdu
- 153
- September 9, 2026
【EXPERT Q&A】For suppliers without mature export cases, what else can be written on the enterprise page?

Drugdu.com expert’s response: Many new suppliers on the platform get stuck on one question when completing their company profile page: “We don’t have many mature export cases yet, so is there nothing substantial to write in our company introduction?” This is especially true for enterprises in the API, excipient, pharmaceutical intermediate and medical device sectors. If they do not yet have stable overseas orders or representative clients, they can easily end up with a very empty and generic company page. Common generic lines include: “We are a professional supplier.” “We provide high quality products.” “We have competitive prices and good service.” These statements are not technically wrong, but overseas buyers can hardly tell exactly what the enterprise is capable of delivering after reading them. Not having mature export cases does not mean your company page has to be empty. When buyers visit a company page, they do not only look ...
- Source: drugdu
- 126
- September 7, 2026
【EXPERT Q&A】Is ce certification required for products exported to the European Union?

Drugdu.com expert’s response: Products exported to the EU ‌do not all require CE marking‌. Only product categories explicitly covered by the EU’s unified harmonised regulations are mandatorily required to affix the CE mark. Products outside the scope of the regulations do not need to apply for CE certification, nor may they use the CE mark arbitrarily. Mandatory Application Areas for CE Certification ‌Core regions‌: All EU member states, plus Iceland, Liechtenstein and Norway (the three EEA countries), where CE marking is a legal market access requirement. ‌Other recognized regions‌: Turkey also recognizes CE certification as a basis for market access, subject to confirmation in accordance with the latest local regulations. ‌Special note‌: After Brexit, the UK no longer fully recognizes the CE mark on its domestic market, and the UKCA marking requirements shall apply instead. Common Product Categories Mandatorily Requiring CE Certification ‌Electrical and electronic products‌: Household appliances, lighting equipment, ...
- Source: drugdu
- 134
- September 2, 2026
【EXPERT Q&A】What on earth is the buyer looking at when he asks for the latest three batches of COA at once?

Drugdu.com expert’s response: When doing API foreign trade, you often encounter such inquiries. The customer has already confirmed the product name and specifications, and has obtained one copy of COA. After one or two rounds of communication, they put forward a new request: “Could you provide COAs for the latest three batches?” Some suppliers may feel confused: since one COA already shows all product indicators, why do customers need three consecutive batches? When a customer starts to review data of consecutive batches, their focus is no longer limited to confirming “whether you have this product”, but further judging whether this supplier can be included in their procurement system. I. One COA Shows Indicators, Multiple Batches Prove Stability A single COA can only reflect the test result of one specific batch. For customers who plan to make long-term purchases, this is far from sufficient. Taking APIs as an example, buyers will ...
- Source: drugdu
- 134
- August 31, 2026

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