Expert Q&A – media

【EXPERT Q&A】How can clinical evaluations be carried out efficiently under the EU MDR regulation?

Drugdu.com expert’s response: Under the EU MDR Regulation, the core of efficiently carrying out clinical evaluation is to avoid repeated rectification in the later stage and greatly shorten the compliance cycle through advance planning, process standardization and pre-risk control. Below are the directly implementable efficient methods: 1. Build a Standardized Clinical Evaluation Plan (CEP) in Advance ‌Clarify core elements‌: Directly anchor the general safety and performance requirements supported by clinical data, the precise target patient population of the product, and quantifiable clinical benefit indicators in the plan to avoid repeated supplementation in subsequent stages. ‌Align compliance boundaries in advance‌: Proactively align with the requirements of MDR Annex XIV and MDCG 2021-6 guideline, so as to avoid common problems caused by missing plan elements from the very beginning. ‌Reserve a gap prediction session‌: Preset the execution nodes for literature retrieval and data assessment in advance, to identify potential clinical evidence gaps ...
- Source: drugdu
- 44
- August 21, 2026
【EXPERT Q&A】What are the registration requirements for exporting medical devices to Brazil?

Drugdu.com expert’s response: For medical devices exported to Brazil, ‌all products that enter the Brazilian market for circulation, sale and clinical use must complete ANVISA-related registration/notification, which is a mandatory pre-requisite for legal entry, and there is no general compliance exemption‌. Below is the complete latest 2026 registration requirements: 1. Core Regulatory Basic Requirements ‌Regulatory Authority‌: All medical devices are uniformly regulated by the Brazilian National Health Surveillance Agency (ANVISA). Overseas manufacturers cannot submit registration applications directly, and must appoint a ‌Brazilian Local Registration Holder (BRH)‌ with a valid Brazilian CNPJ tax number as the legally responsible entity, who is in charge of submitting technical documents, undertaking post-market adverse event reporting, recall execution and other compliance responsibilities. ‌Basic Legal Basis‌: Anchored in Law 6,360/1976, Law 9,782/1999, supported by technical details such as the RDC 751/2022 risk classification rules and RDC 665/2022 GMP specifications. 2. Risk Classification and Corresponding Registration Paths ...
- Source: drugdu
- 53
- August 19, 2026
【EXPERT Q&A】Why is the cycle of drug clinical trials usually very long?

Drugdu.com expert’s response: Many people assume that the lengthy R&D timeline of a new drug stems from slow experimental execution. In reality, the most time-consuming part is rarely running experiments, but the continuous verification of whether the drug is truly effective and sufficiently safe. Before a new drug moves from the laboratory to the market, it typically goes through multiple stages, each with distinct research objectives. Any problem identified in a single link may require supplementary studies or even a full restart of relevant procedures. ‌Clinical trials are conducted in sequential phases‌ After a drug enters human trials, it usually needs to go through Phase I, Phase II and Phase III clinical trials. Phase I focuses on safety, evaluating human tolerance to the drug and observing its absorption, distribution, metabolism and excretion (ADME) in the human body. Phase II initiates efficacy verification, explores appropriate dosing regimens, and continues to accumulate ...
- Source: drugdu
- 54
- August 17, 2026
【EXPERT Q&A】The buyer only left the product name and country. What else should be asked in the first round?

Drugdu.com expert’s response: It is quite common for overseas buyers to leave very limited information in their first inquiry. Some buyers only fill in the product name and their country, without specifying specifications, quantities or detailed procurement needs. At this point, many suppliers’ first reaction is to quote directly. But in fact, when the demand information is incomplete, the quotation can only be a reference price, and repeated confirmations will be needed later. This not only increases communication costs, but may also affect the buyer’s procurement experience. Instead of rushing to quote, the top priority of the first round of communication is to figure out the buyer’s real needs, so as to prepare for providing more accurate product solutions and quotations later. ‌Confirm product specifications or models‌ The same product often comes in different models, specifications, concentrations, sizes or packaging methods. Especially for products like medical devices and API (Active ...
- Source: drugdu
- 63
- August 14, 2026
【EXPERT Q&A】Should this inquiry be prioritized for follow-up when the buyer in the pharmaceutical foreign trade scenario starts to request the COA, specification sheet and samples?

Drugdu.com expert’s response: In pharmaceutical foreign trade, after receiving an inquiry, the hardest part is often not figuring out how to reply, but determining which one deserves more of your time investment. Some buyers only send a one-line message saying “Please send price”, while others directly list product specifications, quantities and destination countries. There are also clients who, after two rounds of communication, start requesting COAs, Specifications, GMP documents, and even ask for samples. When several inquiries are laid out in front of you, the one with abundant information may not close a deal immediately, and the seemingly simple inquiry does not necessarily mean there is no procurement plan at all. To judge whether an inquiry is worth following up on with priority, you can refer to several specific behavioral signals from the buyer. Buyers asking about product details are usually more worthy of further exploration than those who only ...
- Source: drugdu
- 68
- August 12, 2026
【EXPERT Q&A】How should a post-market supervision plan for in vitro diagnostic products be established under the EU IVDR regulation?

Drugdu.com expert’s response: Many IVD enterprises, when preparing for EU market compliance, tend to prioritize pre-market requirements such as CE certification, technical documentation and performance evaluation. However, regulatory obligations do not terminate once the product is placed on the market. In accordance with the EU IVDR, manufacturers are mandated to establish a Post-Market Surveillance (PMS) system to continuously collect post-launch real-world usage data, safety performance and potential risks of the device, and implement corresponding corrective actions based on the feedback. For IVD enterprises planning to access the EU market, the post-market surveillance plan shall be established as follows: 1. Define the objectives and scope of post-market surveillance in advance Prior to developing the PMS plan, the enterprise shall explicitly determine: The product portfolio covered by the surveillance scope; The sales territories of the products; Target user groups; Risk class of each product; Key issues requiring prioritized attention. Different IVD products ...
- Source: drugdu
- 62
- August 10, 2026
【EXPERT Q&A】What are the key requirements of the EU CE for the design and development control of medical devices?

Drugdu.com expert’s response: The key requirements of EU CE for medical device design and development control, which are centered on full-process compliance management, are mainly divided into the following modules: I. Planning Phase Before initiating the design, a complete project plan shall be formulated, clarifying project objectives, timelines, resource allocation, risk assessment and verification protocols. Accurately define the design inputs based on user requirements, EU regulations, safety standards and technical specifications, and specify core indicators such as the device’s performance, functions and safety. II. Implementation Phase Produce clear and actionable design deliverables, including product drawings, technical specifications, process flows and other contents to facilitate subsequent production and inspection. Organize regular cross-departmental design reviews to ensure that design outputs fully meet the requirements of design inputs, and simultaneously optimize design details. Implement full-process risk management, identify potential risks throughout the design, production and usage processes, and formulate corresponding risk control measures. ...
- Source: drugdu
- 81
- August 7, 2026
【EXPERT Q&A】Why do buyers still not know your advantages after uploading dozens of peptide products?

Drugdu.com expert’s response: Many peptide API enterprises have a common habit when launching overseas promotion: uploading their entire existing product catalog at once, showcasing dozens of varieties or even hundreds of CAS numbers in a single batch. Their logic is straightforward — the broader the product coverage, the higher the chance of being discovered by overseas buyers. However, in actual platform operation, they often encounter a counterintuitive situation: despite a large number of products and considerable page views, the volume of truly matched inquiries remains low. The problem rarely lies in insufficient product quantity; instead, it stems from the failure to present the information buyers need to confirm quickly after landing on the page. There is a distinct difference between peptide API procurement and general chemical product sourcing. Buyers do not judge a supplier’s strength merely by the scale of its product portfolio. What they prioritize are: Whether the enterprise ...
- Source: drugdu
- 79
- August 5, 2026
【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
- 98
- 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
- 96
- July 31, 2026

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