media – Page 6 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

【EXPERT Q&A】What are the core requirements for manufacturers’ QMS under the EU MDR regulation?

Drugdu.com expert’s response: Under the EU MDR, the quality management system requirements for manufacturers are not limited to “production process compliance.” Manufacturers are expected to establish a quality management system that covers the full lifecycle of medical devices. In simple terms, the QMS should demonstrate that the product remains under continuous control from design and development, production and release, through to post-market feedback and risk control. The key requirements can be summarized in five areas: 1. Establish a quality management system that meets MDR requirements Manufacturers need to establish, implement, maintain and continuously improve their QMS. The system should cover processes such as product design and development, production, inspection, release, supplier management, document control, change control, nonconforming product handling, CAPA, internal audits and management review. 2. Include regulatory compliance in the QMS The QMS should clearly define product classification, conformity assessment routes, applicable standards, evidence of compliance with the General ...
- Source: drugdu
- 98
- July 22, 2026
INDO HEALTH CARE (Jakarta Medical Device Exhibition, Indonesia)

Organiser：KRISTA EXHIBITIONS Time： August 5th – 7th, 2026 Address：Jl. Gatot Subroto No.1, RT.1/RW.3, Gelora, Kecamatan Tanah Abang, Kota Jakarta Pusat, Daerah Khusus Ibukota Jakarta 10270, Indonesia Exhibition hall：Balai Sidang Jakarta Convention Center Product range: Medical Devices: Diagnostic medical equipment, traditional Oriental medicine therapies & equipment, dental instruments, clinic examination apparatus, obesity treatment and healthcare equipment, ophthalmic medical instruments Rehabilitation Equipment: Surgical instruments & equipment, therapeutic apparatus & equipment, radiological medical equipment, hospital facilities and emergency equipment, central supply equipment, Asian medicine & related devices, rehabilitation healthcare supplies, disposable instruments, other medical-related products Medical Supplies: Ward nursing equipment and appliances (beds, trolleys, tables, cabinets, racks, etc.); Disinfection products (medical air sterilizers, vacuum sterilizers, ultrasonic cleaning systems, disinfectants, etc.); Auxiliary products (oxygen generators, ventilators, sphygmomanometers, blood glucose meters, thermometers, potential therapy devices, radiation protection supplies, oxygen generation & supply equipment, blood bank facilities, medical data & image processing equipment, rehabilitation devices, special ...
- Source: drugdu
- 125
- July 21, 2026
【EXPERT Q&A】How are medical devices classified and managed?

Drugdu.com expert’s response: Medical devices are classified and managed into three categories ‌in ascending order of risk level‌, with the Rules for the Classification of Medical Devices as the core basis. 1. Management Classification of Three Categories of Medical Devices ‌Class I‌: Medical devices with low risk, whose safety and effectiveness can be ensured through routine management, such as ordinary medical surgical masks and medical examination gloves. ‌Class II‌: Medical devices with moderate risk that require strict control and management to ensure safety and effectiveness, such as clinical thermometers and non-invasive monitors. ‌Class III‌: Medical devices with relatively high risk that need particularly strict control measures to ensure safety and effectiveness, such as implantable cardiac pacemakers and artificial joints. 2. Supporting Classification Management Rules In addition to the risk classification of the products themselves, China also implements classified and hierarchical supervision for the production and operation links, clarifying the responsibilities of regulatory ...
- Source: drugdu
- 85
- July 20, 2026
【EXPERT Q&A】The product has page views, but why are there still no inquiries?

Drugdu.com expert’s response: Recently, some suppliers have raised a very practical question: “My products already have views. Why are there still no buyer inquiries?” This is quite common for medical device products. When medical device buyers browse products on a platform, they usually do not send an inquiry immediately after seeing one product. They first make a judgment: Is this the product I am looking for? Is this company reliable? Can the certificates and documents support my target market? Will communication with this supplier be complicated? So, having views does not mean inquiries will come right away. Views show that the product has received a certain level of exposure. But whether buyers are willing to make further contact depends on whether the product page and company information can support their sourcing decision. 1. Buyers saw the product, but did not see a clear reason to contact you For many product ...
- Source: drugdu
- 87
- July 20, 2026
China Cell Biology Industry Conference (CBIC)

Organiser：Beijing Life Science and Technology Industry Association, Shanghai Biomedical Industry Association Time：July 16–18, 2026 Address：Fuhua 3rd Road, Futian District, Shenzhen Exhibition hall：Shenzhen Futian Convention & Exhibition Center Product range: Antibody drugs, stem cells and regenerative medicine, immune cell therapy, cell-based drugs, 3D cell culture, cellular multi-omics, organoids, exosomes, target screening, pharmaceutical innovation, novel vaccines, gene therapy, oncolytic viruses, etc. About CBIC： The China Cell Biology Industry Conference (CBIC) and Biomedical Innovation Cooperation Conference will cover core topics including antibody drugs, stem cells and regenerative medicine, immune cell therapy, cell-based drugs, 3D cell culture, cellular multi-omics, organoids, exosomes, target screening, pharmaceutical innovation, novel vaccines, gene therapy, and oncolytic viruses. The conferences will focus on cutting-edge biotech advances, clinical applications, industrialization processes, investment and financing opportunities, industry standardization, and emerging regulatory trends. The biomedical industry is one of China’s key strategic emerging industries. Currently, China is the world’s second-largest pharmaceutical ...
- Source: drugdu
- 130
- July 16, 2026
Chinese innovative drugs score a Blockbuster Deal! AstraZeneca buys out Suvolotinib for $1.5 billion

Originally produced by Yang Xixia, Jianshi Bureau, July 14, 2026 20:24 Beijing On July 14, China’s innovative drug industry saw another major deal: ج Dizal Pharma willgrant AstraZeneca the exclusive global development and commercialization rights to suvolotinib. AstraZeneca will pay Dizal Pharma a $600 million upfront payment and $900 million in milestone payments, with clinical development and sales milestones capped at $400 million and $500 million, respectively. Simply put, AstraZenecabought out suvolotinib outright for $1.5 billion. As soon as the news broke, Dizal Pharma’s stock surged 20CM in the afternoon. The capital market recognized the certainty of this deal. Unlike other BD deals that often run into the billions of dollars, Dizhe’s $1.5 billion total may not be large, but the $600 million upfront payment is real cash in hand, and the future milestone payments are also highly certain. This is the fundamental reason the market is willing to pay ...
- Source: drugdu
- 116
- July 15, 2026
【EXPERT Q&A】Why Do Medical Device Products Get Views but No Inquiries?

Drugdu.com expert’s response: Recently, some suppliers have raised a very practical question: “My products already have views. Why are there still no buyer inquiries?” This is quite common for medical device products. When medical device buyers browse products on a platform, they usually do not send an inquiry immediately after seeing one product. They first make a judgment: Is this the product I am looking for? Is this company reliable? Can the certificates and documents support my target market? Will communication with this supplier be complicated? So, having views does not mean inquiries will come right away. Views show that the product has received a certain level of exposure. But whether buyers are willing to make further contact depends on whether the product page and company information can support their sourcing decision. 1. Buyers saw the product, but did not see a clear reason to contact you For many product ...
- Source: drugdu
- 91
- July 15, 2026
MEDITECH

Organiser：Medical Association of Bogotá Chamber of Commerce, Messe Düsseldorf GmbH Time：July 28th – July 31st, 2026 Address：CORFERIAS Bogotá – Colombia Todos los derechos reservados, Carrera 37 No 24 – 67 Conmutador Exhibition hall：Corferias Bogota Product range: Medical Instruments and Equipment: Surgical instruments, surgical orthopedic supplies, orthopedic products, diagnostic equipment, monitoring equipment, therapeutic equipment, disinfection and sterilization equipment, preventive medical equipment, ophthalmic instruments and equipment, otolaryngological equipment, radiological medical equipment, rehabilitation physiotherapy equipment, traction and correction equipment, prosthetics and rehabilitation devices, medical vehicles, beds and tables, first-aid and ambulance equipment, medical auxiliary equipment, etc. Medical Institutions and Laboratory Technical Equipment: Laboratory instruments and equipment, laboratory furniture, laboratory automation and accessories, optical instruments and equipment, medical experimental analysis and diagnostic instruments, biotechnology equipment, etc. Medical Materials: Disposable medical consumables, surgical hygiene products, dressings, wound care materials, catheters, interventional materials, first-aid kits, first-aid packs, other medical materials, etc. Healthcare Products: Medical electronic ...
- Source: drugdu
- 145
- July 14, 2026
【EXPERT Q&A】Before exporting medical devices, first sort out these “easily ambiguous” issues

Drugdu.com expert’s response: Medical devices are a highly regulated product category worldwide. In foreign trade communication, customs clearance, and overseas regulatory inspections, many vaguely expressed, inconsistent, or unsupported details can easily lead to repeated inquiries from buyers, cargo detention, and order delays. Many suppliers only briefly inform customers that “all certificates are complete and compliant” without sorting out industry-specific controversial points in advance, resulting in repetitive and inefficient communication.I. Qualification Certificates: Complete in Name but Mismatched in Details (Most Frequently Questioned) This is the most frequently questioned area by customers. Many companies only generally claim to have “a full set of certificates,” yet suffer from inconsistent information, ambiguous scope of application, and unclear validity periods. Domestic Qualification Matching Common ambiguities: Whether the model, production address, and product scope on the Class I/II/III medical device registration/filing certificate, production license, and export sales certificate are fully consistent; whether a compliant export ...
- Source: drugdu
- 103
- July 13, 2026
【EXPERT Q&A】Why Do Buyers Keep Asking Questions Even After You Say “All Certificates Are Complete”?

Drugdu.com expert’s response: In daily sales and procurement communication, many suppliers share a common confusion: even after clearly telling buyers that “all certificates are complete and qualifications are formal,” the other party still keeps asking questions and repeatedly requests various supporting documents. Many people assume that the buyer is distrustful or deliberately being difficult, but this is not the case. Such behavior is not personal; it is an inevitable result of risk control, compliance requirements, process standards, and trust-building in the procurement process, with very practical and reasonable underlying logic. First and foremost, the buyer’s core concern is the authenticity and validity of the certificates. The current market environment is complex, and cases of forged certificates, misappropriated certificates, expired qualifications, and use beyond authorized scope are not uncommon. Especially in highly regulated industries such as pharmaceuticals, chemicals, food, building materials, and import/export, one non-compliant qualification can lead to seizure of ...
- Source: drugdu
- 102
- July 10, 2026

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