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【EXPERT Q&A】What is the difference between medical devices and non-medical devices?

Drugdu.com expert’s response: The differences between medical devices and non-medical devices are primarily manifested in the following six aspects: Ⅰ. Definition and Purpose Medical Devices: Refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related articles, including the necessary computer software, that are directly or indirectly used on the human body. Their efficacy is primarily obtained through physical means rather than through pharmacology, immunology, or metabolism, or if these means are involved, they only play an auxiliary role. The primary purposes include diagnosis, prevention, monitoring, treatment, or alleviation of diseases, as well as diagnosis, monitoring, treatment, alleviation, or functional compensation of injuries. Non-Medical Devices: Generally refer to products that are not directly used on the human body or, even if in contact with the human body, do not have a medical purpose. They may be daily necessities, industrial products, consumer goods, such as ...
- Source: drugdu
- 77
- September 27, 2024
2 injections for 1 year, a preview of conquering AIDS

Since June 2024, all scholars around the world who care about AIDS prevention have focused their attention on Gilead’s antiviral drug lenacapavir. At that time, Gilead announced the latest data of the PURPOSE 1 trial conducted by lenacapavir, and the results showed that: in the case of head-to-head daily oral PrEP drugs, lenacapavir achieved 0 infection with 2 injections per year. This means that in the case of unfavorable vaccine development, lenacapavir is expected to replace the preventive effect of the vaccine with its ultra-persistent prevention characteristics. Of course, is the result of the PURPOSE1 trial accidental or inevitable? No one can give an answer. But in September, Gilead continued to provide PURPOSE 2 trial data, indicating to the outside world that the possibility of inevitability is greater. The results showed that 99.9% of the participants in the Lenacapavir group were not infected with HIV, and the risk of infection ...
- Source: drugdu
- 71
- September 27, 2024
Bausch&Lomb is in a crisis of being sold

Recently, according to the Financial Times, Bausch Lomb, the world’s second-largest ophthalmic giant, is seeking to sell itself and completely spin off from its parent company, Bausch Health. In recent years, under the implementation of merger and acquisition strategies, Doctoral Health has developed its business pipeline comprehensively. However, due to being trapped in a huge debt crisis, it had to reduce its burden and slim down. Bausch&Lomb is one of the targets of its sale and spin off this time. Mergers and acquisitions are both successful and unsuccessful Bausch&Lomb was founded in New York, USA in 1853 and was listed on both the New York Stock Exchange and the Toronto Stock Exchange in 2022. It has a development history of nearly 170 years. At first, Bausch&Lomb was just a small eyewear store, but over the years, it has become one of the world-renowned eye care companies. From the perspective of ...
- Source: drugdu
- 82
- September 26, 2024
How to layout after recall and reorganization? Philips CEO responds

Recently, Roy Jakobs, CEO of Philips, gave an interview to foreign media and responded to questions such as how to reverse the company’s situation after a large-scale recall and the company’s restructuring plan. According to data, Philips was founded in the Netherlands in 1891 and mainly produces products in lighting, household appliances, and medical systems. The company has transformed from a Philips family business to a global multinational corporation managed by modern professional managers. In its 130 year history, it has evolved from a lighting business to a diversified enterprise that covers almost everything, and then continuously “slimmed down”. Eventually, it sold off its lighting business, leaving only medical care. It has successfully transformed from an electronics group into a global top medical technology giant, leading in the fields of imaging diagnosis, image-guided therapy, patient monitoring, health informatization, consumer health, and home care. In October 2022, Roy Jakobs became the ...
- Source: drugdu
- 91
- September 26, 2024
CMEH

Organiser：China Healthcare Industry Association, Chinese Medical Exchange Association Time：June 25 – 27, 2025 address：No. 1099 Guozhan Road or No. 111 Shiboguan Road, Pudong New Area, Shanghai, China Exhibition hall：Shanghai World Expo Exhibition & Convention Center Product range: Medical Imaging: CT, DR, Medical X-ray Systems, Ultrasound Diagnostic Instruments, MRI Equipment, Tumor Treatment Machines, Medical Film and Processing Systems, etc.; Remote & Mobile Intelligent Medical Monitoring: Sleep Monitors, Remote ECG, Blood Pressure, Blood Oxygen, Body Temperature Monitoring, Cloud Blood Pressure Monitors, Bluetooth Blood Pressure & Blood Glucose Monitors, Wearable Medical Devices, Health Kiosks, etc.; Diagnostic & Therapeutic Equipment: Endoscopy Systems, ENT Treatment Instruments, Dynamic Analysis Instruments, Cryogenic Freezing Equipment, Dialysis Treatment Equipment, Emergency Equipment, Surgical Instruments, Electrosurgical Units & Consumables, Laser Surgical Instruments, Ultrasound Surgery, etc.; Ward Nursing Equipment & Appliances: Beds, Trolleys, Tables, Cabinets, Racks, etc.; Disinfection Products: Medical Air Sterilizers, Vacuum Sterilizers, Ultrasonic Cleaning Systems, Disinfectants/Solutions, etc.; Auxiliary Products: ...
- Source: drugdu
- 197
- September 26, 2024
Ocuvision nails first generic anti-allergic eye drop

Last week (September 9 to September 15), a total of 58 varieties passed/were deemed to have passed the consistency evaluation. During the same period, 123 varieties applied for consistency evaluation. According to the official website of NMPA, Suzhou Ocuvision Biotechnology Co., Ltd. (hereinafter referred to as “Ocuvision”)’s cetirizine hydrochloride eye drops obtained a marketing approval on September 10. The drug is indicated for the treatment of itchy eyes associated with allergic conjunctivitis and is suitable for people aged 2 years and above. Allergic conjunctivitis is an allergic disease of the eye that occurs more frequently in spring and autumn. The disease is mainly manifested by itchy eyes, accompanied by red and swollen eyelids, congestion and edema of the conjunctiva (white eyeballs), increased tears or white secretions, and some patients also have symptoms such as nasal congestion, itchy nose, clear runny nose, and sneezing. Cetirizine hydrochloride eye drops are one of ...
- Source: drugdu
- 84
- September 26, 2024
Major Pharmaceutical Holdings’ Subsidiary for Traditional Chinese Medicine Officially Starts Production

On September 24, reporters from Dahe Finance learned through Major Pharmaceutical Holdings’ official WeChat account that recently, the opening ceremony for Chongqing Pharmaceutical Group Jiulong Modern Traditional Chinese Medicine Co., Ltd. (hereinafter referred to as “Zhongyao Jiulong”) was held in Nanchuan District, Chongqing City. Officials from relevant departments, including the Chongqing Economic and Information Commission, the Health Commission, and the Drug Administration, as well as leaders from the Nanchuan District Committee and District Government, attended the ceremony. Noteworthy attendees included Qiu Huaiwei, Secretary of the Party Committee and Chairman of China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. (hereinafter referred to as “China Resources Sanjiu”), and Yuan Quan, Secretary of the Party Committee and Chairman of Chongqing Pharmaceutical (Group) Co., Ltd. (hereinafter referred to as “Zhongyao Group”). Zhongyao Jiulong was established in October 2020 through joint investment from Major Pharmaceutical Holdings’ subsidiary, Zhongyao Group, and China Resources Sanjiu. The company ...
- Source: drugdu
- 70
- September 26, 2024
Stryker InSpace Balloon Obtains C Code! Revolutionary Treatment for Huge, Irreparable Rotator Cuff Tears

After being approved for marketing in China, the absorbable implantable balloon InSpace System (hereinafter referred to as InSpace absorbable implantable balloon) developed and produced by Stryker has made another major breakthrough. On September 20, after strict review by the National Medical Insurance Administration, the product obtained the medical insurance medical consumables code (hereinafter referred to as C code), laying the foundation for obtaining the qualification for online procurement in various provinces in the next step. In July this year, the Medical Device Technology Review Center of the State Food and Drug Administration approved the marketing application of InSpace absorbable implantable balloon in China for the treatment of huge, irreparable, full-thickness tears of rotator cuff tendons caused by trauma or degeneration. As the only shoulder joint implantable balloon approved for marketing in the world by 2024, the product can be implanted under the acromion through minimally invasive surgery to restore shoulder ...
- Source: drugdu
- 85
- September 26, 2024
Jointown will “double-list”?

On September 23, Jointown released a progress announcement on the application and issuance of public REITs for pharmaceutical warehousing and logistics infrastructure. Industry insiders pointed out that if the subsequent process can be completed smoothly, Jointown will achieve “listing + 1”, and realize the “double listing” of Jointown and public REITs. However, at present, this process is still in the stage of formally submitting application materials. Jointown said that if the public REITs project is successfully issued, it is expected to increase net profit by no more than 700 million yuan. Jointown public REITs is expected to become the first domestic pharmaceutical logistics warehousing facility, as well as the first private enterprise in Hubei Province, to achieve the synergy and win-win of Jointown and public REITs “double listing” platform. Jointown has about 3 million square meters of pharmaceutical logistics warehousing assets and supporting facilities that can be pooled. The pooled ...
- Source: drugdu
- 71
- September 26, 2024
Shiyao Group’s $1.195 billion overseas expansion, Claudin 18.2 ADC awarded FDA fast track certification

Insight Database On September 23rd, Elevation Oncology announced that the FDA has granted fast track designation to EO-3021 (SYSA1801) for the treatment of advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer patients expressing Claudin 18.2. The drug was developed by Shiyao Group and authorized overseas equity to Elevation for a total of $1.195 billion in 2022. Image source: Enterprise official website EO-3021 is a potentially most differentiated clinical stage ADC drug of its kind, consisting of an IgG1 monoclonal antibody targeting Claudin 18.2 connected to MMAE via a cleavable linker, with a DAR value of 2. In preclinical studies, the product showed specific growth inhibitory activity on Claudin 18.2 expressing cells in vitro, and had a strong anti-tumor effect on mice implanted with gastric cancer, pancreatic cancer or lung cancer models in vivo. The product has also been proven to be safe for rodents and non-human primates. On July ...
- Source: drugdu
- 94
- September 25, 2024

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