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【EXPERT Q&A】What testing and certification are required for the export of medical device products?

Drugdu.com expert’s response: Medical device export testing and certification requirements are not determined by “export” as a general concept. They mainly depend on the target market + product category + risk classification. The same product may face very different requirements when exported to the EU, the United States, the UK, or Southeast Asia. Generally, the requirements can be assessed from the following aspects: I. Basic General Requirements 1. ISO 13485 Quality Management System Certification ISO 13485 is one of the most common quality management system certifications for medical device companies. It is often recognized by overseas customers, registration authorities, and procurement channels. It is not a “market access certificate” for every country, but it is usually an important basic document for medical device export. ISO 13485 focuses on whether the company has established a quality management system that meets medical device regulatory requirements, including design and development, production control, risk ...
- Source: drugdu
- 63
- May 29, 2026
MEDICA

Organiser：MEDICA Time：November 16–19, 2026 Address：Ostfach 10 10 06, D-40001 Düsseldorf Stockumer Kirchstraße 61, D-40474 Düsseldorf, Germany Exhibition hall：Düsseldorf Exhibition Center Product range: Medical Equipment: Medical electronic instruments, clinical analysis instruments, dental equipment & materials, hemodialysis equipment, respiratory equipment, hospital ward / operating room / emergency room equipment, hospital office equipment, etc. Imaging & Diagnostics: Ultrasound systems, X-ray equipment, medical optical instruments Disposable Consumables: Disposable medical supplies, dressings & hygiene materials, surgical instruments, etc. Medical Aids: Healthcare aids, home care products, physiotherapy, orthopedic technology, etc. Medical Peripherals: ICT, medical services & publications, IT systems & IT solutions, etc. Laboratory Equipment Physiotherapy / Orthopedic Technology About MEDICA： MEDICA, the world’s largest and most authoritative trade fair for hospital and medical equipment, is held annually in Düsseldorf, Germany. With an irreplaceable scale and influence, it ranks first among global medical trade shows. The exhibition covers the entire spectrum from outpatient to ...
- Source: drugdu
- 58
- May 28, 2026
Bombshell! Eli Lilly Spends Nearly $4 Billion to Acquire Three Drug Firms, Returning to the Vaccine Track

On May 26 (today), Eli Lilly announced agreements to acquire three vaccine companies — Curevo Inc., LimmaTech Biologics AG, and Vaccine Company, Inc. — officially entering the human vaccine arena. This acquisition is part of Eli Lilly’s strategy to continuously invest in differentiated technology platforms and tackle major health challenges. In its 150-year history, Lilly has made significant progress in diabetes, obesity, Alzheimer’s disease, autoimmune diseases, and cancer. Infectious diseases, as a major driver of global morbidity, still pose unresolved public health challenges in terms of acute illness and long-term health consequences from primary infections. Dr. Daniel M. Skovronsky, Eli Lilly’s Chief Scientific and Product Officer and President of Lilly Research Laboratories, stated that this acquisition reflects the company’s strategic direction of preventing disease at its source rather than merely treating its consequences. Existing research shows that common infections may trigger neurological diseases, cancer, infertility, and other conditions years later. ...
- Source: drugdu
- 72
- May 27, 2026
Eltramod has been approved for marketing in South Korea, providing a new oral option for moderate to severe ulcerative colitis

On May 25, 2026, Eternal Medicines officially announced that the Korean Ministry of Food and Drug Safety (MFDS) has approved the new drug application for eltromod (trade name: Vistip®) . This drug will be used to treat adult patients with moderate to severe active ulcerative colitis who have not responded well to or are intolerant of traditional treatments or biologics, bringing a new treatment option to patients in Korea. Ulcerative colitis, a chronic inflammatory bowel disease, has an incompletely understood etiology and is characterized by a high recurrence rate. Typical symptoms such as mucus and bloody stools, abdominal pain, and diarrhea severely impact patients’ quality of life. In recent years, the incidence of this disease has been steadily increasing in Asia, creating an urgent clinical need for safe, effective, and convenient treatment drugs. Visip® is a highly selective sphingosine-1-phosphate (S1P) receptor modulator taken orally once daily. Through optimized pharmacological design, ...
- Source: drugdu
- 68
- May 27, 2026
Expanding Overseas Markets Again! Shengze Kanghua Ophthalmic Center’s IVD Products Receive TFDA Registration Certificate in Thailand

Guangdong Shengze Kanghua Biomedical Co., Ltd.’s self-developed ophthalmic IVD product has successfully passed the review of the Thai Food and Drug Administration (TFDA) and obtained the Thai medical device registration certificate , officially gaining approval to enter the Thai market! The approved products include: ✅ i-ImmunDx Analyzer ✅ Alpha-lymphotoxin (LTA) test kit ✅ Tear Total Immunoglobulin E (Total IgE) Detection Reagent ✅ Human matrix metalloproteinase 9 (MMP-9) detection reagent ✅ Micro-liquid collector Expanding overseas to create new opportunities From Europe to Southeast Asia, another key move has been made in the globalization strategy. This further expands the company’s international footprint. Previously, Shengze Kanghua’s comprehensive ophthalmic diagnostic solutions had been successfully implemented in several European countries , including the UK, Italy, and Spain, achieving stable commercial sales and gaining widespread recognition in overseas markets. Obtaining TFDA certification this time signifies the company’s successful expansion from Europe into the core Southeast Asian ...
- Source: drugdu
- 59
- May 27, 2026
Industry News | CSPC Pharmaceutical Group’s Budesonide Enteric-coated Capsules Receive Drug Registration Approval

On May 21, CSPC Pharmaceutical Group (1093.HK) announced that its budesonide enteric-coated capsules (4mg) (hereinafter referred to as “the product”) have obtained a drug registration certificate issued by the National Medical Products Administration of the People’s Republic of China. Budesonide is a corticosteroid with potent glucocorticoid activity and relatively weak mineralocorticoid activity, exhibiting extremely high first-pass metabolism. Budesonide inhibits the proliferation of mucosal B cells and their differentiation into plasma cells in the Peyer’s patchy lymph nodes of the ileum, thereby suppressing the production of galactose-deficient IgA1 antibodies (Gd-IgA1). It reduces the deposition of immune complexes in the glomerular mesangial area, leading to glomerulonephritis and decreased renal function, by reducing the formation of Gd-IgA1 antibodies and immune complexes in systemic circulation. This product is used to treat adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression to reduce renal function loss. Compared to other drugs, this ...
- Source: drugdu
- 59
- May 27, 2026
First! Gilead’s new hepatitis drug Hepcludex receives FDA approval

Recently, the FDA announced accelerated approval for Gilead Sciences’ Hepcludex (Bulevirtide-gmod) injection for the treatment of chronic hepatitis D virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis . This is the first FDA-approved therapy for the treatment of chronic HDV infection; previously, the FDA had granted it Breakthrough Therapy Designation and Orphan Drug Designation. This is not only the first FDA-approved therapy for chronic HDV infection, but also a key breakthrough in the global treatment of hepatitis D. Hepcludex was jointly developed by Gilead Sciences and MYR GmbH. In 2021, Gilead acquired MYR GmbH for approximately €1.45 billion, recognizing the immense potential of this world-first HDV attachment inhibitor. As an HDV attachment inhibitor targeting NTCP (sodium taurocholic acid cotransport peptide) , Hepcludex inhibits HDV infection by binding to the HDV receptor NTCP on the hepatocyte membrane, blocking the attachment of HDV to NTCP. Hepcludex first received marketing ...
- Source: drugdu
- 64
- May 27, 2026
A $7 billion nuclear medicine deal is imminent.

According to Bloomberg, Lantheus Holdings (LNTH), a company focused on radiopharmaceuticals, is evaluating a potential sale following a takeover offer from private equity-backed Curium Pharma . The offer values the radiopharmaceutical giant at approximately $7 billion , and if the deal goes through, it would be one of the most significant mergers and acquisitions in the global nuclear medicine field in 2026. Lantheus Holdings, headquartered in Massachusetts, USA, is one of the oldest companies in the radiopharmaceutical field, with its origins tracing back to New England Nuclear, founded in 1956. Over the decades, Lantheus has transformed from a traditional SPECT drug supplier into a platform company centered on PET radiodiagnostics . The company’s full-year revenue reached $1.54 billion in 2025, and its revenue for the first quarter of 2026 was $377.3 million. Lantheus’ flagship product, PYLARIFY (piflufolastat F 18) , was the world’s first radiodiagnostic drug to surpass $1 billion ...
- Source: drugdu
- 58
- May 27, 2026
【EXPERT Q&A】What certifications are required for the export of active pharmaceutical ingredients to Japan?

Drugdu.com expert’s response: I. Mandatory Core Certifications MF (Master File) Registration Authority: Japan PMDA / Ministry of Health, Labour and Welfare (MHLW) Purpose: Full API technical dossier registration, linked review with Japanese pharmaceutical companies Requirement: Must be submitted through a domestic Japanese agent; valid for 5 years AFM (Approved Foreign Manufacturer) Designation Basis: Japan Pharmaceutical and Medical Device Act (PMD Act) Purpose: Legal export qualification for overseas API manufacturers Requirement: Renewed every 5 years; export prohibited without AFM Japan GMP Compliance (MHLW Ordinance No. 179) Basis: ICH Q7 + Japan GMP Method: PMDA on-site inspection Outcome: GMP Compliance Certificate, valid for 5 years II. Required Supporting Documents (Per Batch / Ongoing) Japanese domestic agent (responsible for submission, communication, and handling inquiries) GQP (Good Quality Practice) Quality Agreement (signed with Japanese MAH) Per-batch CoC (Certificate of Compliance) — batch number / specifications / test results / expiry date Certificate of Origin ...
- Source: drugdu
- 65
- May 27, 2026
Good news! Asartan potassium tablets have been approved

Recently, Hefei Lifang Pharmaceutical Co., Ltd. received the Drug Registration Certificate for Mesartan Potassium Tablets ( 40mg , 80mg ) issued by the National Medical Products Administration . Mesartan potassium is a prodrug of the angiotensin II receptor blocker class. After oral absorption, it is rapidly converted into the active ingredient, azilsartan. The product for which marketing authorization is being applied is azilsartan potassium tablet, indicated for the treatment of essential hypertension in adults. The original manufacturer is Takeda Pharmaceutical Company Ltd. of Japan. The company’s esculent potassium API was approved for marketing in April 2026. The acquisition of the Drug Registration Certificate for esculent potassium tablets will further enrich the company’s product pipeline, enhance the company’s integrated industrial chain advantages in raw materials and formulations, and improve the company’s market competitiveness. https://mp.weixin.qq.com/s/GxAXMABZsxOGm0mvDJhsxg
- Source: drugdu
- 69
- May 26, 2026

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