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【EXPERT Q&A】What is the process for medical device export?

Drugdu.com expert’s response: The process of exporting medical devices involves multiple steps, as detailed below: Ⅰ. Market Research and Preparation Target Market Research: Conduct in-depth research on the medical device demand, regulations, standards, and competitors in the target market. Understand factors that may affect transactions, such as the target market’s political stability, trade policies, and currency exchange rate fluctuations. Product Registration and Certification: Complete product registration and certification according to the regulatory requirements of the target market. For example, the European market requires CE certification, and the US market requires FDA registration. Ensure that the products comply with the regulations and standards of the destination country to avoid trade barriers and compliance risks. Establishing a Sales Network: Establish contact with distributors, agents, or medical institutions in the target market. Participate in international exhibitions, seminars, and other events to communicate face-to-face with potential customers and showcase product advantages. Ⅱ. Production and ...
- Source: drugdu
- 86
- October 21, 2024
Four consecutive A! Prolo Pharmaceutical received the highest evaluation for its information disclosure work on the Shenzhen Stock Exchange again

Recently, the Shanghai and Shenzhen Stock Exchanges released the evaluation results of information disclosure for the years 2023-2024, and Prolo Pharmaceutical (stock code: 000739) received the highest rating of A in the annual information disclosure evaluation of listed companies on the Shenzhen Stock Exchange. Prolo Pharmaceutical has won this honor for four consecutive years, fully reflecting the high recognition of the securities regulatory authorities for the company’s standardized operation level, information disclosure quality, and investor relations management.The evaluation of information disclosure work on the Shenzhen Stock Exchange is a comprehensive assessment of multiple dimensions such as internal governance, information disclosure quality, investor relations management, and social responsibility fulfillment of listed companies. It is an important indicator for measuring the level of governance and information disclosure quality of listed companies. Listed companies that receive A-level evaluations can not only enhance the recognition of the capital market, but also enjoy policy support ...
- Source: drugdu
- 72
- October 21, 2024
2.5 billion+2.3 billion! Sanofi adds more nuclear weapons

Original Xie Ling Arterial New Medicine October 18, 2024 08:27 Chongqing Yesterday (October 17th), Sanofi announced that it has reached an agreement with Orano Med, a subsidiary of the Orano Group, to further accelerate the development of next-generation radioligand therapy (RLT) by leveraging their expertise in combating rare cancers. According to the agreement, Sanofi and Oueno will jointly invest in a new entity operated under the Oueno Medical brand, focusing on the discovery, design, and clinical development of next-generation radioligand therapy (RLT) based on lead-212 (①¹² Pb) alpha emitting isotopes. Sanofi will make an equity investment of 300 million euros (approximately 2.313 billion yuan), accounting for approximately 16% of the equity of the new entity Orano Medical, with a valuation of 1.9 billion euros (approximately 14.648 billion yuan). At the beginning of last month, Sanofi announced a licensing agreement with RadioMedix and Orano Med for RLT, focusing on AlphaMedix, a ...
- Source: drugdu
- 85
- October 21, 2024
Large pharmaceutical companies, change of controlling shareholders

On October 17, Zhejiang Inter Group issued the “Indicative Announcement on the Change of Controlling Shareholders and Exemption from the Offer for this Transaction”. Huachen Investment transferred nearly 122 million shares of Inter Group held by it to Zhejiang Pharmaceutical and Health Industry Group, the controlling shareholder of Huachen Investment, free of charge; at the same time, Zhejiang International Trade Group entrusted the voting rights corresponding to nearly 151 million shares of Inter Group held by it to Zhejiang International Trade’s wholly-owned subsidiary Zhejiang Pharmaceutical Group for exercise. After this change of rights and interests, Zhejiang Pharmaceutical Group can actually control the voting rights corresponding to nearly 322 million shares of Inter Group. As of September 30, 2024, it accounts for 61.67% of Inter Group’s total share capital. So far, the controlling shareholder of Inter Group has changed from Zhejiang International Trade to Zhejiang Pharmaceutical Group, and the actual controller ...
- Source: drugdu
- 68
- October 21, 2024
Countdown to the 2024 medical insurance negotiations, these drugs are the focus

According to multiple sources in the industry, from October 16 to 18, the National Medical Insurance Administration conducted pre-negotiations with companies that passed expert reviews. As in last year, “pre-negotiations” give companies ample opportunities for communication. Before the formal negotiations, the National Medical Insurance Administration specially organized experts and companies that intend to participate in the negotiations to fully communicate around the payment standard calculations for the intended negotiated products. The medical insurance party and the enterprise party first go through a round of “pre-negotiations” before the formal negotiations, which can facilitate the enterprise party to more fully understand the negotiation rules, and when the formal negotiations are held, the results will be relatively ideal. Previously, the National Medical Insurance Administration had organized fund calculations and pharmacoeconomic calculations in Xiaotangshan, Beijing. On September 19, the National Medical Insurance Administration held an on-site communication meeting for companies to negotiate/bid in Beijing. ...
- Source: drugdu
- 71
- October 21, 2024
Huawei enters the hot track of medical devices

Recently, the website of the State Intellectual Property Office updated a new invention patent, named “Method for controlling stimulator, stimulator, brain-computer interface system and chip”, and the inventor of the patent is Huawei Technologies Co., Ltd. It is reported that this is Huawei’s second brain-computer interface related patent. As early as June 2023, Huawei announced a patent called “A brain-computer interface device and information acquisition method”. Brain-computer interface is one of the most popular phenomenal technologies in recent years, and its potential in the medical field is highly expected by the industry. According to McKinsey’s calculations, the potential market size of global brain-computer interface medical applications is expected to reach US$40 billion in 2030, and it is expected to exceed the US$145 billion mark by 2040. With the increase in R&D investment, the medical application of brain-computer interface has gradually shifted from early abstract concepts to landing results. In September, ...
- Source: drugdu
- 72
- October 21, 2024
The National Medical Insurance Administration issued a document! Special governance is being carried out nationwide

On October 16, the National Medical Insurance Administration issued the “Notice of the Office of the National Medical Insurance Administration on Standardizing the Management of Prescriptions for Medical Insurance Drugs Outside the Hospital”, proposing to carry out special governance on the use of prescriptions outside the hospital. Before the end of December 2024, special inspections will be carried out on prescription drugs for outpatient chronic diseases and special diseases, urban and rural residents’ outpatient “two diseases” medication mechanism, and other prescription drugs with high amounts, high costs, and high risks of fraud and insurance fraud. The National Medical Insurance Administration requires that, relying on big data analysis, paper prescriptions with large usage must be checked, single prescriptions with large dosages must be checked, repeated prescriptions of the same insured person must be checked, single designated medical institutions with large paper prescriptions must be checked, and key departments with large prescriptions ...
- Source: drugdu
- 66
- October 21, 2024
The National Medical Insurance Administration issued a document! Special governance is being carried out nationwide

On October 16, the National Medical Insurance Administration issued the “Notice of the Office of the National Medical Insurance Administration on Standardizing the Management of Prescriptions for Medical Insurance Drugs Outside the Hospital”, proposing to carry out special governance on the use of prescriptions outside the hospital. Before the end of December 2024, special inspections will be carried out on prescription drugs for outpatient chronic diseases and special diseases, urban and rural residents’ outpatient “two diseases” medication mechanism, and other prescription drugs with high amounts, high costs, and high risks of fraud and insurance fraud. The National Medical Insurance Administration requires that, relying on big data analysis, paper prescriptions with large usage must be checked, single prescriptions with large dosages must be checked, repeated prescriptions of the same insured person must be checked, single designated medical institutions with large paper prescriptions must be checked, and key departments with large prescriptions ...
- Source: drugdu
- 81
- October 19, 2024
What are the considerations behind the acquisition of Yikuai Pharmaceutical by Yaoshibang?

On October 15, Yaoshibang issued an announcement that it had signed a transaction agreement to acquire 100% of the equity of Yikuai Pharmaceutical, with a total consideration of RMB 1.035 billion, including a cash consideration of RMB 420 million and a share consideration of RMB 615 million. In the pharmaceutical industry, where mergers and acquisitions are common, this transaction with a total price of RMB 1 billion has attracted considerable attention. The reason is that this is not only the first large-scale acquisition of Yaoshibang, a pharmaceutical B2B e-commerce unicorn, since its listing, but also related to Yaoshibang’s own financial situation. Amid the tightening of listing, Yaoshibang successfully rang the bell on the Hong Kong Stock Exchange in June 2023. However, as a “digital enterprise that deeply cultivates the outpatient market” that went public at a loss, Yaoshibang had just turned a profit when it handed in its full-year performance ...
- Source: drugdu
- 73
- October 19, 2024
RNA editing pioneers fought a comeback

This is the title of an article published in Nauter in February this year (Move over, CRISPR: RNA-editing therapies pick up steam). RNA editing technology, which is coming to the fore, is seen as a potential to surpass CRISPR due to its safer and more flexible characteristics. The technology is in its infancy, and the bets of MNCs such as Eli Lilly and GSK have once pushed its popularity to a climax. However, Wave, an RNA editing pioneer founded in 2012, took more than 10 years to push its first RNA editing project WVE-006 into clinical trials. During this period, due to the clinical failure of other nucleic acid drugs, Wave’s stock price fell from a high of US$56 per share to around US$1 per share, and market expectations were no longer met. After years of silence, a counterattack driven by clinical data is taking place. On October 16, Wave ...
- Source: drugdu
- 77
- October 19, 2024

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