Expert Q&A – media

【EXPERT Q&A】When overseas buyers contact multiple suppliers simultaneously, is it still necessary for enterprises to invest a lot of time in following up?

Drugdu.com expert’s response: When conducting foreign trade in pharmaceuticals and medical devices, suppliers frequently encounter this scenario: overseas buyers send inquiries asking about product prices, specifications, delivery lead times, and relevant qualifications. After a period of communication, they later discover that the buyer has simultaneously contacted several suppliers, and even explicitly stated that they are comparing quotations and supply terms from different companies. Some suppliers consequently reduce the priority of these inquiries, assuming that since the buyer is reaching out to multiple firms, they may not ultimately select their offer. This is especially true for products like APIs, pharmaceutical excipients, and medical equipment, where preparing quotations, COAs, specifications, and other technical documentation takes considerable time. If the effort only ends up helping the buyer gather market information, the upfront investment can seem to hold little value. However, in pharmaceutical B2B procurement, it is quite common for buyers to evaluate multiple ...
- Source: drugdu
- 96
- November 9, 2026
【EXPERT Q&A】If the buyer requests the API to provide stability data, is it sufficient for the supplier only to have the COA?

Drugdu.com expert’s response: When exporting Active Pharmaceutical Ingredients (APIs), overseas buyers often request suppliers to provide Certificates of Analysis (COA), product specifications, and GMP-related documentation. However, after initial communication, some customers will further ask for Stability Data to confirm the product’s quality changes under different storage conditions. This can sometimes pose a dilemma for suppliers. While enterprises can provide COAs for recent batches to prove that products meet quality standards at the time of release, buyers still demand long-term stability data, accelerated stability study results, and even inquire about the product’s re-test period and storage conditions. So why are stability data required even when a COA is already available? If an enterprise does not yet have a complete stability study report, will this affect subsequent procurement? COA and Stability Data Demonstrate Different Quality Attributes A COA (Certificate of Analysis) primarily indicates whether the test results of a specific batch of ...
- Source: drugdu
- 75
- November 6, 2026
【EXPERT Q&A】What regulatory requirements should be noted when applying for an IVDRCE certificate for self-tested in vitro diagnostic reagents in the European Union?

Drugdu.com expert’s response: For enterprises preparing to export products such as pregnancy test strips, urine test strips, and infectious disease self-test kits to the EU, IVDR CE conformity assessment is a critical step to enter the EU market. Compared with in vitro diagnostic reagents mainly used by laboratory professionals, self-test products also need to consider whether ordinary consumers can correctly operate and interpret test results, as well as the health risks that may arise from improper use. The EU Regulation on In Vitro Diagnostic Medical Devices (EU) 2017/746, known as IVDR, has been applicable since May 26, 2022. This regulation sets requirements for the classification, performance evaluation, technical documentation, quality management system and post-market surveillance of IVD products. When enterprises apply for IVDR CE-related certificates, they need to pay special attention to the following aspects. First, it is necessary to confirm whether the product is a self-testing IVD and its ...
- Source: drugdu
- 75
- November 4, 2026
【EXPERT Q&A】What exactly are the General Safety and Performance Requirements (GSPR) that medical devices must meet to obtain the EU CE marking?

Drugdu.com expert’s response: When medical device enterprises prepare to enter the EU market, they often come into contact with requirements such as CE marking, MDR regulations, technical documentation and GSPR. Among them, GSPR is a particularly critical part of technical documentation preparation and product conformity assessment. Some enterprises have already obtained the ISO 13485 quality management system certification and completed product performance tests, but when preparing EU MDR technical documents, they find that they still need to explain item by item how their products meet GSPR requirements. So what exactly is GSPR? What is its relationship with CE certification and product standards? GSPR refers to the general safety and performance requirements for medical devices in the EU. Its full English name is General Safety and Performance Requirements, which are specified in Annex I of the EU Medical Device Regulation (EU) 2017/745 (MDR). To put it simply, the EU requires that ...
- Source: drugdu
- 83
- November 2, 2026
【EXPERT Q&A】What issues should the supplier pay attention to when the buyer requests the last three batches of COA?

Drugdu.com expert’s response: When exporting APIs, pharmaceutical intermediates and pharmaceutical excipients, suppliers often encounter situations where overseas buyers request a COA (Certificate of Analysis). Some customers only ask for one COA to gain a preliminary understanding of product quality, while others, after confirming product specifications, further express their wish to review the COAs of the latest three batches. For suppliers, a single COA is usually easy to provide, but consecutive three batches of COAs involve actual test data from different production batches, which requires more careful preparation. Why do buyers want to see three batches? Does it mean their procurement intention is relatively clear? If there are differences in the test results of different batches, will it affect the buyer’s judgment? These problems are very common in overseas procurement of pharmaceutical products such as APIs. Why do buyers request the COAs of the latest three batches? For pharmaceutical enterprises with ...
- Source: drugdu
- 138
- October 30, 2026
【EXPERT Q&A】The product has received inquiries, but there are no orders for a long time. Is it still worth promoting?

Drugdu.com expert’s response: When conducting foreign trade in pharmaceuticals and medical devices, some enterprises often encounter such a situation: after their products are launched on B2B platforms, they receive inquiries from overseas buyers one after another. Some ask for prices, some request COAs and product specifications, and others further inquire about packaging, purchase quantities and delivery lead times. Suppliers provide the required documents and complete quotations as requested, yet one or two months pass without any actual orders being formed. At this point, enterprises will inevitably begin to doubt the effectiveness of their promotion efforts. Clearly, there are already consultations, but why have no transactions been closed? Are the buyers insincere about procurement, or are the products uncompetitive? Is it still necessary to continue promoting this product? For pharmaceutical B2B businesses, there is often a procurement evaluation process between an inquiry and a confirmed order. Especially for products like APIs, ...
- Source: drugdu
- 130
- October 28, 2026
【EXPERT Q&A】‌‌What are the mandatory core requirements for NMPA registration materials of Class II active medical devices?

Drugdu.com expert’s response: When enterprises apply for domestic registration of Class II active medical devices, they need to focus on demonstrating the product’s safety, effectiveness and quality controllability. Compared with some passive medical devices, active products usually involve functions such as power supply, circuits, software, control systems and energy output. Therefore, in the registration review process, electrical safety, electromagnetic compatibility (EMC), software verification and product performance are the key areas of concern. In accordance with the Regulations on Administration of Medical Device Registration and Filing of the National Medical Products Administration (NMPA) and Announcement No. 121 of 2021, domestic Class II medical devices are subject to registration review and approval by the provincial drug regulatory department where the enterprise is located, while imported Class II medical devices are reviewed and approved by the NMPA. The registration application materials shall be prepared in accordance with the specified catalogue and format, and the technical ...
- Source: drugdu
- 125
- October 26, 2026
【EXPERT Q&A】‌‌With a large number of main products, which items should an enterprise prioritize for overseas promotion?‌

Drugdu.com expert’s response: When many pharmaceutical and medical device enterprises start overseas promotion, they will encounter a common problem: there are dozens or even hundreds of products in the company’s product catalog, but which ones should be prioritized for key promotion on B2B platforms? Some enterprises are used to uploading all their existing products, believing that the more products they list, the higher the chance of being searched by overseas buyers. Others directly select several best-selling products in the domestic market, assuming that items performing well at home will surely meet demands in overseas markets. Both ideas are reasonable to a certain extent, but more factors need to be taken into account in actual overseas procurement scenarios. Whether a product can attract buyers’ attention is related not only to market demand, but also to the enterprise’s supply capacity, product documentation, target market access status and peer competition. A Large Product ...
- Source: drugdu
- 145
- October 23, 2026
【EXPERT Q&A】‌To what extent should an enterprise prepare when overseas buyers inquire whether products can support local registration?‌

Drugdu.com expert’s response: When conducting foreign trade in pharmaceuticals and medical devices, some overseas buyers, after confirming product specifications and prices, will further ask: “Can you support product registration in our country?” This question may seem straightforward to suppliers. If an enterprise holds relevant certificates such as GMP, CE, or ISO 13485, or has past export experience, it can easily reply directly that it can support registration. However, the “registration support” mentioned by buyers may involve far more work than just providing a few certificates. Especially for pharmaceuticals, APIs and medical devices, there are significant differences in registration pathways, application entities, technical documents and approval requirements across different countries. The fact that a supplier can provide product materials does not mean these materials already meet local registration requirements; nor does the fact that a product has been approved for marketing in one market mean it can directly enter another. What Are ...
- Source: drugdu
- 147
- October 23, 2026
【EXPERT Q&A】What is the process for applying for a medical device registration certificate?

Drugdu.com expert’s response: When applying for a Medical Device Registration Certificate, you should not start by simply asking “what documents to prepare”. The more accurate workflow is to first determine the classification of the medical device, confirm the competent regulatory authority for acceptance, and finally prepare the testing, clinical evaluation, quality system and registration application documents. In China, Class I medical devices are subject to filing management, while Class II and Class III medical devices are subject to registration management. That is to say, the “Medical Device Registration Certificate” in the general sense mainly corresponds to Class II and Class III medical devices. Domestic Class III medical devices, as well as imported Class II and Class III medical devices, are reviewed and approved by the National Medical Products Administration (NMPA); domestic Class II medical devices are generally the responsibility of the provincial drug regulatory authorities. Before initiating the process, the ...
- Source: drugdu
- 122
- October 19, 2026

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