Expert Q&A – Page 4 – media

【EXPERT Q&A】How to handle the production filing for medical devices?

Drugdu.com expert’s response: The medical device production filing is only applicable to the production activities of ‌Class I Medical Devices‌. Applications shall be submitted to the municipal drug regulatory department with districts where the enterprise is located, and the filing certificate can be issued on the spot if the conditions are met. The production of Class II and Class III medical devices does not apply to the filing system. It is required to apply for the official Medical Device Production License from the provincial drug regulatory department. I. Pre-application Preparation Requirements ‌Personnel Requirements‌: It is required to appoint qualified quality principals, technical principals, and at least 2 full-time inspectors. Personnel in relevant positions shall have a technical secondary school degree or above in medical device-related majors, and the personnel in other positions can be flexibly configured according to the actual situation of the enterprise. ‌Site & Facilities‌: The nature of the production ...
- Source: drugdu
- 122
- August 28, 2026
【EXPERT Q&A】Is it easy to obtain the Class II Medical Device Operation License?

Drugdu.com expert’s response: The overall difficulty of applying for the relevant operation qualifications for Class II medical devices is moderate. Most enterprises that meet the basic conditions can successfully complete the filing, with core difficulties concentrated in three aspects: personnel qualification, site compliance, and the implementation of system documents. 🎯 Core Factors Affecting Application Difficulty ‌Qualification Nature Difference‌: The operation of Class II medical devices is currently subject to the ‌filing system‌ in the vast majority of regions across the country, rather than a strict license approval system. Compared with the operation license for Class III medical devices, it has lower application thresholds and less strict review standards. Most regions support full-process online handling, and some regions even promise a processing time of only 1 working day. ‌Personnel Qualification Requirements‌: Enterprises are required to appoint full-time quality management personnel, who shall hold a college diploma or corresponding professional title in ...
- Source: drugdu
- 127
- August 26, 2026
【EXPERT Q&A】For new API suppliers joining the platform, should they choose “popular varieties” or “varieties with the most complete data” for their first batch of products?

Drugdu.com expert’s response: When many API suppliers first settle on a platform, they will encounter a common dilemma: which products should be uploaded as the first batch? Some enterprises prioritize popular varieties. Their reasoning is straightforward: these products are actively sought after in the market, boast higher search volumes, and have a greater chance of being noticed by buyers. Other enterprises prefer to upload varieties with the most complete documentation first. These products come with full COAs, specification sheets, GMP documents, DMF status statements, and even proven export experience. While they may not be the current top trending items, the enterprise can respond quickly and professionally whenever a buyer makes an inquiry. Neither approach is inherently wrong. The problem is that if you only focus on “popularity”, you will lack supporting documentation later, and inquiries will easily stall at the first round of communication. If you only select “fully documented ...
- Source: drugdu
- 176
- August 24, 2026
【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
- 170
- 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
- 164
- 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
- 119
- 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
- 132
- 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
- 154
- 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
- 137
- 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
- 142
- August 7, 2026

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