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【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
- 39
- August 26, 2026
DUPHAT

Organiser：INDEX Conferences & Exhibitions Time：August 25 – 27, 2026 Address：Sheik Zayed Road Convention Gate Dubai UAE – United Arab Emirates Exhibition hall：Dubai World Trade Centre Product range: Finished Pharmaceuticals: Various OTC and prescription drugs, Chinese patent medicines, Western medicines, new drugs, specific medicines, biopharmaceuticals, traditional Chinese medicines, herbal raw materials, various pharmaceutical raw materials, chemical pharmaceuticals, pharmaceutical intermediates and other medical products Pharmaceutical Raw Materials (Intermediates): Vitamins, hormones, sulfonamides, antipyretic analgesics, tetracyclines, amino acids and their derivatives, chloramphenicols, digestive system drugs, other anti-infective agents, penicillins, aminoglycosides, lincomycins, cardiovascular system drugs, antiparasitic drugs, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, other Western pharmaceutical raw materials Excipients and Dosage Forms: Excipients, glidants, enteric materials, antioxidants, sweeteners, penetration enhancers, preservatives, disintegrants, coating materials, surfactants, opacifiers, flavors, filter aids, stabilizers, lubricants, plasticizers, solvents, corrigents, colorants, clarifying agents, pH regulators, others Pharmaceutical Technology: Pharmaceutical production equipment and technologies, pharmaceutical packaging equipment, cleaning ...
- Source: drugdu
- 45
- August 24, 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
- 69
- 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
- 59
- August 21, 2026
CPhI Korea

Organiser：Informa Markets Time：August 25 – 27, 2026 Address：COEX Convention & Exhibition Center Exhibition hall：513 Yeongdong-daero, Gangnam District, Seoul, Republic of Korea Product range: Active Pharmaceutical Ingredients (APIs)‌: Vitamins, Hormones, Sulfonamides, Antipyretic Analgesics, Tetracyclines, Amino Acids and Their Derivatives, Chloramphenicols, Digestive System Medications, Other Anti-Infective Agents, Penicillins, Aminoglycosides, Lincomycins, Cardiovascular System Medications, Antiparasitic Drugs, Cephalosporins, Macrolides, Respiratory System Medications, Central Nervous System Medications, Other Western Pharmaceutical Raw Materials ‌Excipients and Dosage Forms‌: Excipients, Glidants, Enteric-Coating Materials, Antioxidants, Sweeteners, Penetration Enhancers, Preservatives, Disintegrants, Coating Materials, Surfactants, Opacifiers, Flavors, Filter Aids, Stabilizers, Lubricants, Plasticizers, Solvents, Flavor Correctors, Colorants, Clarifying Agents, pH Regulators, Others ‌Natural Extracts‌: Plant Extracts, Animal Extracts, Traditional Chinese Medicine Raw Materials, Functional Food Raw Materials, Health Supplement Raw Materials, Nutraceutical Raw Materials, Dietary Supplements, Dietary Fiber, Cosmetic Raw Materials About CPhI Korea ： CPhI Korea was first launched in 2014. Adopting an integrated model that organically combines exhibitions, ...
- Source: drugdu
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- August 20, 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
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- August 19, 2026
Haixi’s new drug HX9428 receives Fast Track designation from the US FDA.

Forwarding our company’s announcement dated August 17, 2026: The Board of Directors of our Company is pleased to announce that HX9428, a drug candidate molecule of our independently developed innovative drug project HXP056, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the development of a treatment for neovascular age – related macular degeneration ( nAMD, also known as wet age-related macular degeneration, wAMD) . This FTD designation will facilitate closer communication between our Company and the FDA regarding the clinical development of HX9428 and advance its global clinical development process. HX9428 is a novel oral small molecule drug independently developed by Haixi New Drug, intended for the treatment of nAMD. Currently, anti-vascular endothelial growth factor (anti-VEGF) therapy remains the standard treatment for nAMD. However, existing treatments require intravitreal injection into the eye, which may lead to long-term, repeated treatments, resulting in medical ...
- Source: drugdu
- 146
- August 18, 2026
Just now, Fosun Pharma licensed 10 biosimilar drugs for overseas markets!

Just now, Fosun Pharma issued an announcement stating that its holding subsidiary, Henlius Biotech, signed a “Cooperation Framework Agreement” with Sandoz AG , which will allow Henlius Biotech to cooperate with Sandoz AG on the registration, commercialization, development, and production of up to 10 monoclonal antibody ( mAb ) and / or antibody-drug conjugate ( ADC ) biosimilar products or ingredients in relevant overseas regions . The first three collaborative products are HLX05-N , HLX16 , and belimumab biosimilars, with the collaboration scope covering the treatment of all human indications, but limited to indications approved for the original products in the relevant countries / regions of the collaboration area; one potential collaborative product (options have been granted to the collaborators) is HLXTE-HAase1001 . For the first three collaborative products, Henlius may receive up to US$314 million in upfront payments, development milestones and development budget milestones, and sales milestone payments (subject ...
- Source: drugdu
- 78
- August 18, 2026
Lunan Pharmaceutical’s Milrinone Lactate Injection Receives Marketing Approval in Malaysia

Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a drug registration certificate for Milrinone Lactate Injection issued by the Malaysian Food and Drug Administration ( NPRA ), marking that the product has officially obtained market access in Malaysia and can be sold and commercialized there. Milrinone lactate injection is a phosphodiesterase inhibitor with both positive inotropic and vasodilatory effects. It is a drug that rapidly improves hemodynamics and is suitable for acute and chronic refractory congestive heart failure caused by ineffective or poorly responded treatment with digitalis, diuretics, and vasodilators. Currently, milrinone lactate injection produced by Lunan Pharmaceutical has been approved for marketing in the United States, Ukraine, Costa Rica, and other countries. Furthermore, marketing applications have been submitted in more than 20 countries and regions, including Vietnam, Saudi Arabia, Brazil, and the United Kingdom. During the product’s marketing application process in Malaysia, the ...
- Source: drugdu
- 66
- August 18, 2026
Lunan Pharmaceutical’s Ningte® isoflurane for inhalation receives marketing approval in Pakistan.

Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a drug registration certificate (registration number: 135844) for inhaled isoflurane issued by the Drug Regulatory Authority of Pakistan (DRAP) , marking that the product has officially obtained market access in Pakistan and can be sold and commercialized there. Inhaled isoflurane is suitable for the induction and maintenance of general anesthesia. With its advantages of rapid induction, rapid recovery, and low metabolic rate , it is widely used in various surgical procedures. Currently, this product is available in China, the United States, and Japan, and registration applications are underway in several overseas markets. The company is accelerating its global supply strategy to provide patients with a safe and effective anesthetic option. During the registration process in Pakistan, the registration team strictly adhered to local regulations, efficiently prepared technical documentation, and communicated with reviewers, leading to the successful ...
- Source: drugdu
- 72
- August 18, 2026

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