【EXPERT Q&A】How to apply for a medical device business license?

Drugdu.com expert’s response:   Obtaining a Medical Device Distribution License — the key is to first clarify which class of devices you intend to distribute, as the process for Class II and Class III is completely different. Clarify: Are you applying for a “License” or “Filing”? Class I (Low Risk) — e.g., surgical scalpels, gauze, stethoscopes: Filing during business registration is sufficient. No license required. Class II (Medium Risk) — e.g., blood pressure monitors, thermometers, nebulizers: File with the municipal drug regulatory authority. This is not called a license. Class III (High Risk) — e.g., cardiac stents, CT scanners, ventilators, contact lenses: You must apply for a Medical Device Distribution License from the municipal drug regulatory authority. When people ask about a “license,” they usually mean Class III. The following covers Class III. Application Requirements (Five Mandatory Criteria — All Must Be Met) Personnel: The quality manager must hold a college degree or higher (or intermediate professional ...

• Source: drugdu
• 35
• June 19, 2026

BIO Asia Taiwan — the Asia Biotech Conference & Exhibition

Organiser：Taiwan Bio-Industry Development Association Time：July 15–19, 2026 Address：No. 1, Jingmao 2nd Road, Nangang District, Taipei Exhibition hall：Taipei Nangang Exhibition Center, Trade Center, Taipei   Product range: Pharmaceuticals: New drug development, vaccine preparations (gene therapy, cell therapy), generic drugs, active pharmaceutical ingredients (APIs), Chinese herbal medicine Medical Devices: Medical device R&D, medical electronics, medical imaging, medical instruments, composite medical materials Biotech Services & Testing: Genetic testing, reagents, biochips, cord blood, stem cells, medical services, clinical and pre-clinical trial services (CRO), contract manufacturing (CMO), logistics Equipment & Instruments: Instruments, pharmaceutical equipment (components), packaging, printing, turnkey plant equipment Beauty & Wellness: Medical aesthetic centers, beauty and skincare products, raw materials, packaging containers, beauty instruments, ODM/OEM design services Food & Health: Biotech raw materials, health foods, nutritional supplements, beverage industry, OEM/ODM Agriculture, Fisheries & Aquaculture: Aquaculture, floriculture, bio-fertilizers, bio-pesticides Biotech Funds & Venture Capital: Banking, securities advisory, venture capital, legal, accounting   About BIO ...

• Source: drugdu
• 43
• June 18, 2026

On June 16, foreign media suddenly reported several pieces of news about semaglutide. One was that Novo Nordisk’s oral weight-loss drug Wegovy would soon be launched in China; another was that Novo Nordisk made it clear: regulatory data protection for semaglutide in China will last until the second quarter of 2027, when generics will be able to enter the market. According to foreign media reports, both pieces of news came from Novo Nordisk’s Global President and CEO, Mike Doustdar. In the past few days, Novo Nordisk’s global management has happened to be visiting China. On June 15, Health News reported that Lei Haichao, Director of the National Health Commission, met with several Novo Nordisk executives, to discuss Novo Nordisk’s presence in China and its future strategy. The two major pieces of news above were very likely leaked during this public event, drawing strong market attention. The news about oral semaglutide ...

• Source: drugdu
• 55
• June 17, 2026

World’s first! CSPC Group’s paclitaxel for injection (albumin-bound) (II) approved for marketing

  On June 15, CSPC Group’s paclitaxel for injection (albumin-bound) (II) (R&D code: SYHX2011) was approved for marketing by the National Medical Products Administration. This product is the world’s first fast-dissolving albumin-bound paclitaxel formulation, backed by independently developed innovative formulation and manufacturing processes, and has obtained patent authorizations in multiple countries including China, the U.S., and Europe. As a Class 2.2 modified new chemical drug, it represents a comprehensive upgrade in efficacy, safety, and clinical convenience, filling many of the clinical gaps of conventional albumin-bound paclitaxel, marking CSPC Group’s technological breakthrough in the field of antitumor nanomedicines and offering a better chemotherapy option for patients with advanced breast cancer. Figure 1. CSPC paclitaxel for injection (albumin-bound) (II) approved for marketing, source: NMPA website 01Breast Cancer and Taxanes Breast cancer is a highly prevalent malignant tumor in China. According to a report by the National Cancer Center of China, there were ...

• Source: drugdu
• 59
• June 17, 2026

Valuation of 7 billion yuan! Another large financing deal lands in the vaccine sector

On the evening of June 15, Fosun Pharma (600196) issued an official announcement that its vaccine platform, Fosun A&T, had completed a new round of capital increase and share expansion, issuing an additional 11.4954 million shares to four investors at a price of RMB 84.21 per share, raising a total of RMB 968 million and implying a pre-investment valuation of RMB 7 billion. This is a key capital move in Fosun A&T’s preparation for a Hong Kong IPO, and it has also injected important momentum into the R&D and commercialization of its vaccine pipeline.I. A star-studded investor lineup: Fosun leads the round, with China Resources and Chengdu state-owned capital joining in The investor mix in this capital increase is highly representative of the industry, underscoring the capital market’s long-term confidence in the vaccine sector: • Fosun Pharma Industry (controlling shareholder): Invested RMB 550 million to subscribe for 6.5315 million shares, ...

• Source: drugdu
• 50
• June 17, 2026

【EXPERT Q&A】What problems do pharmaceutical companies have in the quality management of drug production?

Drugdu.com expert’s response:   Common issues in pharmaceutical production quality management are generally concentrated in the following areas: Personnel & Awareness Quality management in many companies remains at the level of “passing inspections” rather than being truly internalized into production habits. Frontline operators have high turnover, training is superficial, and SOP non-compliance is widespread. The quality department lacks authority and often yields to production when output and quality conflict. Data Integrity This is a key regulatory enforcement focus in recent years. Handwritten records are casually altered, electronic data lacks audit trails, abnormal data is deleted without trace, and shared login accounts are common — especially prevalent among small and mid-sized pharma companies. FDA and NMPA requirements on data integrity are tightening, yet many companies’ IT systems are still stuck at the Excel stage. Deviation & Change Control Out of Control When deviations occur, the first instinct is to find a workaround, ...

• Source: drugdu
• 43
• June 17, 2026

Pharma Pro & Pack Expo

Organiser： IPMMA (Indian Pharmaceutical Machinery Manufacturers’ Association), GPE Exhibitions Time：July 9–11, 2026 Address：HITEX Exhibition Centre, Izzat Nagar, Hyderabad 500 032, A.P. Exhibition hall：Hyderabad International Trade Exposition Centre (HITEX)   Product range: Machinery & Equipment: Pharmaceutical processing and packaging, laboratory equipment Materials: Packaging materials and consumables, glassware, laboratory ware and consumables Chemicals & Pharmaceuticals: Active Pharmaceutical Ingredients (APIs), excipients, laboratory reagents and chemicals, bulk formulations, active pharmaceutical substances Project Management: Utilities, consulting, turnkey services, eco-friendly products and services Trade Promotion: Trade associations, institutions, publications Others: Pharmaceutical production services, contract manufacturing, CRO/CDMO service providers, research institutions, testing laboratories and related services   About Pharma Pro & Pack Expo： Pharma Pro & Pack Expo is the largest, most leading, and most influential pharmaceutical packaging exhibition in South Asia. Co-organized by the Indian IPMMA Association and GPE Exhibitions, the event has received strong support from official media and India’s healthcare industry. Since the establishment of ...

• Source: drugdu
• 51
• June 16, 2026

【EXPERT Q&A】How do the approval and supervision processes of medical devices ensure their safety?

Drugdu.com expert’s response:   The core logic is: risk-based classification → strict pre-market review → continuous post-market surveillance, forming a full lifecycle closed loop. I. Classification: Risk Determines Regulatory Intensity Under the Regulation on the Supervision and Administration of Medical Devices, devices are divided into three classes: Class I (Low Risk): Filing system, formal review only. Examples: medical cotton swabs, surgical gowns. Class II (Moderate Risk): Registration system, reviewed and approved by provincial drug administration. Examples: blood pressure monitors, CT scanners. Class III (High Risk): Registration system, reviewed and approved by the National Medical Products Administration (NMPA). Examples: cardiac stents, artificial joints. Higher risk means stricter review — classification itself is the first safety filter. II. Pre-Market Approval: Four Core Gates Taking Class II and III as examples: Gate 1: Product Technical Requirements & Testing Must complete biological evaluation, electrical safety, performance testing, etc., to prove the product itself is qualified. Class III ...

• Source: drugdu
• 57
• June 15, 2026

【EXPERT Q&A】Do Class II medical device operations require a “license”?

Drugdu.com expert’s response:   No. You don’t need a “license” for Class II medical devices — you only need to file a record . To be precise, the term “Class II Medical Device Operation License” itself is incorrect. According to Article 30 of the Medical Device Supervision and Administration Regulations: Class I: No license required, no filing required Class II: No license required, but filing is mandatory. You obtain a Class II Medical Device Operation Filing Certificate Class III: License required. You apply for a Medical Device Operation License So the correct procedure for Class II is: submit filing materials to the municipal-level drug administration department where the enterprise is located. If materials are complete and meet requirements, the certificate is issued on the spot. The filing certificate has no fixed expiry date. When enterprise information changes, a change filing must be processed. When operations cease, the filing must be actively cancelled.

• Source: drugdu
• 70
• June 12, 2026

CPhI South East Asia

Organiser：Informa Markets Time：July 8–10, 2026 Address：Queen Sirikit National Convention Center, 60 Ratchadaphisek Rd, Khlong Toei, Bangkok 10110, Thailand Exhibition hall：Queen Sirikit National Convention Center   Product range: APIs (Active Pharmaceutical Ingredients): Vitamins, hormones, sulfonamides, antipyretics & analgesics, tetracyclines, amino acids & derivatives, chloramphenicols, digestive system drugs, other anti-infectives, penicillins, aminoglycosides, lincosamides, cardiovascular drugs, antiparasitics, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, other Western chemical APIs Packaging & Machinery: Pharmaceutical machinery, packaging machinery, packaging materials, drug production equipment & technology, drug packaging equipment, drug packaging materials, drug production, cleaning & disinfection systems, and laboratory instrument systems Pharmaceutical Products: Various proprietary Chinese medicines, Western medicines, new drugs, various APIs, chemical pharmaceuticals, pharmaceutical intermediates, biopharmaceuticals, traditional medicines, Chinese herbal medicines, herbal extracts, animal & plant extracts, veterinary drugs, food ingredients & additives, etc.   About CPhI South East Asia： CPhI South East Asia is the most authoritative pharmaceutical ingredients exhibition in ...

• Source: drugdu
• 70
• June 11, 2026