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【EXPERT Q&A】What is the specific process for obtaining a medical device product registration certificate?

Drugdu.com expert’s response: The Process for Obtaining a Medical Device Product Registration Certificate Involves Multiple Steps, Detailed as Follows: I. Preliminary Preparation and Classification Confirmation Product Classification Determination: Based on the Medical Device Classification Catalog and classification criteria, the category is determined by considering factors such as the intended use and mechanism of action of the product. For example, blood glucose test strips fall under Class II, while artificial heart valves are classified as Class III. If no matching category can be found in the existing catalog, a classification determination must be conducted beforehand. Selection of Registration Pathway: Domestic enterprises should proceed with the registration process, while imported products must appoint a domestic agent. For renewal of registration, applications should be submitted six months prior to the expiration of the certificate. Preparation of Technical Requirement Documents: These documents should cover product standards, performance indicators, and test reports, referencing relevant standards. For instance, orthopedic implants must ...
- Source: drugdu
- 62
- April 3, 2026
CMEF SHANGHAI

Organiser：Reed Sinopharm Exhibitions Time：April 9 – April 12, 2026 Address：No. 333 Songze Avenue, Xujing Town, Qingpu District, Shanghai Exhibition hall：National Exhibition and Convention Center (Shanghai) Product range: Medical Imaging Zone: Radiology products, ultrasound products, nuclear medicine products, molecular imaging, interventional products, etc. Operating Room Zone: Hybrid operating rooms, integrated operating room solutions, surgical instruments, anesthetic machines, ventilators, patient monitors, operating room engineering, surgical lights, pendant systems, etc. In Vitro Diagnostics Zone: Total laboratory solutions, clinical diagnostic equipment, diagnostic reagents, point-of-care testing (POCT), home diagnostic devices, etc. Rehabilitation and Physiotherapy Zone: Rehabilitation equipment, assistive devices, traditional Chinese medicine treatments, physical therapy equipment, medical high-frequency equipment, etc. Orthopedics Zone: Orthopedic implant consumables across three major categories (joints, trauma, spine), orthopedic surgical instruments and equipment, bone power tools, and other orthopedic-related products. Medical Informatics Zone: System integrators, mobile healthcare, hospital management, quality control, clinical and other hospital information management systems, IT equipment ...
- Source: drugdu
- 62
- April 2, 2026
【EXPERT Q&A】What testing and certification are required for the export of pharmaceutical products to Japan

Drugdu.com expert’s response: Pharmaceutical products exported to Japan must obtain certification from Japan’s Ministry of Health, Labour and Welfare (MHLW) and meet the following testing and certification requirements: I. Core Certification Requirements 1. Drug Certification Basis of Regulations: Primarily based on the Pharmaceutical and Medical Device Act (Pharmaceutical Affairs Law) and the Food Sanitation Act. Testing Content: Includes ingredient analysis, efficacy evaluation, and safety testing, covering physical and chemical property testing, biological activity testing, and contaminant testing, among others. Certification Process: Submit detailed technical documentation and ingredient descriptions of the product. Provide production process flow and quality control measures. Submit previous testing reports and certificates of compliance. Provide relevant clinical trial data (if applicable). 2. Medical Device Certification PMDA Certification: Medical devices must obtain certification from the Pharmaceuticals and Medical Devices Agency (PMDA), Japan’s regulatory body for pharmaceuticals and medical devices, to ensure compliance with Japanese safety, efficacy, and quality ...
- Source: drugdu
- 78
- April 1, 2026
Sinovac Biotech and Changzhou Pharmaceutical Factory have reached a strategic cooperation agreement and signed an exclusive licensing agreement for two cardiovascular drugs in overseas markets.

Recently, Sinovac BiotechSinovac Biotech Co., Ltd. (hereinafter referred to as ” Sinovac Biotech”)(Stock code 688136.SH) and Shanghai PharmaceuticalsChangzhou Pharmaceutical Factory Co., Ltd. (hereinafter referred to as “Changzhou Pharmaceutical Factory”), a subsidiary of the Group, held a strategic cooperation signing ceremony and an exclusive licensing agreement for two products, ticagrelor tablets and rosuvastatin calcium tablets, in several European countries. Leveraging Sinovac Biotech ‘s mature overseas commercialization network and Changzhou Pharmaceutical Factory’s high-quality product R&D and manufacturing capabilities, the two parties will join hands to expand into the European market, bringing domestically produced cardiovascular drugs to more patients. Enriching the European product line and continuously cultivating the major market It is understood that both products launched through this collaboration have been approved in China and the United States and are currently undergoing registration applications in several European countries. The cooperation covers markets including Germany, Spain, the Netherlands, Italy, and France. Ticagrelor tablets ...
- Source: drugdu
- 175
- March 31, 2026
Bayer’s fenelitonee has been approved in the European Union for use in adult patients with heart failure with LVEF ≥ 40%.

Based on the positive results of the Phase III FINEARTS-HF study, the European Union approved fenelone for patients with heart failure with a left ventricular ejection fraction (LVEF) ≥40%. The study included approximately 6,000 patients with various types and conditions of heart failure with LVEF ≥40%. Fennellone is the first mineralocorticoid receptor antagonist to demonstrate definite cardiovascular benefits in a phase III clinical trial in patients with heart failure and LVEF ≥ 40%. More than 15 million people in Europe suffer from heart failure, of whom about 50% have an LVEF ≥ 40%. Currently, there are limited approved treatment options for this group that meet guideline recommendations, and the risk of cardiovascular events remains high. On March 30, 2026, Bayer announced that the European Commission approved the selective nonsteroidal mineralocorticoid receptor antagonist fenelazor (Cosminda®) for the treatment of adult patients with heart failure with a left ventricular ejection fraction (LVEF) ...
- Source: drugdu
- 91
- March 31, 2026
World’s first! Amgen/AstraZeneca’s blockbuster drug approved for marketing in China

On March 27, the NMPA website showed that terzafimumab injection, a TSLP monoclonal antibody jointly submitted by AstraZeneca and Amgen , was approved for marketing. The drug was approved for two indications: asthma (application number: JXSS2400102/3) and chronic sinusitis with nasal polyps (application number: JXSS2500019/20) . Screenshot source: NMPA official websiteTezaliumab, developed in collaboration between AstraZeneca and Amgen, is a first-in-class human monoclonal antibody that inhibits the action of TSLP. TSLP is a key epithelial cytokine located at the top of multiple inflammatory cascades and is closely associated with allergic, eosinophilic, and other types of endothelial inflammation related to severe asthma and other inflammatory diseases.In 2021, the drug was first approved by the FDA for adjunctive maintenance therapy in adults and children aged 12 years and older with severe asthma . In 2022, it was approved in the European Union and Japan. In October 2025, the drug was approved for a new indication in the United States for maintenance therapy of poorly controlled chronic sinusitis with ...
- Source: drugdu
- 85
- March 31, 2026
Progen Pharmaceuticals’ ephedrine sulfate injection has received exclusive approval, empowering perioperative blood pressure management.

Recently, Zhejiang Procon Pharmaceutical Co., Ltd., a subsidiary of Procon Pharmaceuticals, received exclusive approval for its ephedrine sulfate injection, which is considered to have passed the consistency evaluation. As a blockbuster drug that was exclusively applied for and approved in China, the successful launch of this product not only enriches the company’s anesthetic drug product line, but also fills the clinical gap for ephedrine preparations that can be administered intravenously and are suitable for various anesthetic environments, providing a more standardized and reliable new medication option for patients with perioperative hypotension. Perioperative hypotension is one of the most common complications in clinical anesthesia. According to data from the China Health Statistics Yearbook (2024 Edition), the number of surgeries in my country reached 96.39 million in 2023, with an incidence of hypotension during anesthesia as high as 93%, which is estimated to be nearly 89.64 million cases per year. Clinical demand ...
- Source: drugdu
- 82
- March 31, 2026
The super-big drug race has been upgraded again

Autoimmune diseases have become the second largest pharmaceutical market globally after oncology, with the psoriasis drug segment being particularly prominent, having given birth to multiple “blockbuster drugs” with staggering sales. Although market competition has intensified, the field is undergoing a new round of optimization and upgrading driven by innovative therapies. The treatment of psoriasis has evolved from tumor necrosis factor (TNF) inhibitors (e.g., Humira) to interleukin (IL) inhibitors (e.g., Stelara, Skyrizi), and further to oral small-molecule targeted drugs (e.g., PDE4 inhibitors, JAK inhibitors). Leveraging a large patient population, these drugs have generated cumulative sales exceeding one hundred billion dollars. Currently, psoriasis treatments present a diversified landscape, with validated targets such as JAK, IL-17, IL-23, and TYK2 being focal points of R&D amid fierce competition. Numerous domestic pharmaceutical companies are also actively engaging in follow-up research and development in areas like IL-23, IL-17A/F dual-target, and PDE4 inhibitors, with some products already ...
- Source: drugdu
- 100
- March 31, 2026
The first in nearly 20 years! The FDA has approved the marketing of this innovative drug

Recently, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Denali Therapeutics’ innovative drug Avlayah (tividenofusp alfa) for the treatment of Hunter syndrome (Mucopolysaccharidosis II). This approval marks a dual breakthrough: it is not only the first new treatment option for this disease in nearly 20 years but also the first FDA-approved enzyme replacement therapy that utilizes a transferrin receptor-mediated mechanism to cross the blood-brain barrier. Hunter syndrome is a rare genetic lysosomal storage disorder caused by a deficiency of the enzyme iduronate-2-sulfatase (IDS), leading to abnormal accumulation of glycosaminoglycans throughout the body’s cells, with particularly severe damage to the central nervous system. While traditional enzyme replacement therapies can improve peripheral symptoms, they cannot effectively cross the blood-brain barrier and therefore fail to halt neurological decline. The key innovation of Avlayah lies in its TransportVehicle™ (TV) platform technology. This engineered technology enables the drug to bind to transferrin ...
- Source: drugdu
- 80
- March 31, 2026
The Guangzhou International Exhibition on Laboratory Medicine, In Vitro Diagnostics, and Blood Transfusion Instruments and Reagents (IVDE)

Organiser：China Association for Medical Devices Industry Time：March 30 – April 1, 2026 Address：Intersection of Yingbin Avenue and Fanghua Road, Baiyun District, Guangzhou Exhibition hall：Guangzhou Airport Expo Center Product range: In Vitro Diagnostic Equipment Category: Biochemical analyzers, bacterial analyzers, urine analyzers, microbiological analyzers, electrolyte analyzers, hematology analyzers, blood analyzers, hemodialysis machines, enzyme-linked immunosorbent assay (ELISA) readers, chromatographs, PCR instruments, etc. In Vitro Diagnostic Reagent Category: In vitro diagnostic reagents, rapid diagnostic reagents, electrolyte reagents, hematology reagents, blood coagulation reagents, blood typing reagent kits, lipid reagents, biochemical reagents, chemiluminescent reagents, dry chemistry test strips, reagents for chlamydia detection, protein detection reagents, infectious disease detection reagents, tumor marker reagents, human gene detection reagents, immunohistochemistry and human tissue cell reagents, biochips, vitamin determination reagents, cellular and tissue chemical staining agents, self-diagnostic reagents, microbiological testing reagents, and other diagnostic reagents. Blood Collection and Transfusion Category: Blood collection and supply instruments and equipment, consumables, blood ...
- Source: drugdu
- 77
- March 31, 2026

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