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【EXPERT Q&A】What qualifications do you need to export Class II medical devices to Japan?

Drugdu.com expert’s response: Exporting Class II Medical Devices to Japan requires compliance with Japan’s Pharmaceutical and Medical Device Act (PMD Act). Here are the primary qualifications and steps required: Determining Product Classification and JMDN Code: According to the PMD Act, medical devices are classified into I, II Special Control, II Controlled, III, and IV categories. It is necessary to determine the specific classification and JMDN code for the exported Class II medical devices. Manufacturer Registration: Foreign manufacturers must register their manufacturer information with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), including details on product design, production, and key processes. QMS Factory Audit: For Class II Special Control products, an application for a Quality Management System (QMS) factory audit must be submitted to the authorized certification body, PCB. For other Class II products, as well as Class III and IV products, an application for a QMS factory audit must be submitted ...
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- 522
- January 1, 2025
Welcome 2025! 🌟

Here’s to a new year filled with fresh opportunities and continued success. May 2025 be your most rewarding year yet!
- Source: drugdu
- 449
- January 1, 2025
The Rise of Domestic Production

Proton therapy is known as the “crown jewel” of tumor radiotherapy for its excellent performance, representing the highest level of radiotherapy technology. This technology utilizes the high-energy properties of proton beams to accurately strike tumor tissues while minimizing damage to surrounding normal tissues, bringing unprecedented treatment hope to cancer patients. According to the latest statistics, the number of proton heavy ion therapy centers worldwide has exceeded one hundred, which fully demonstrates the widespread recognition and application of proton therapy technology worldwide. According to market predictions, the global proton therapy market is expected to reach nearly 1.6 billion US dollars by 2031, which fully reflects the enormous potential and broad prospects of proton therapy technology. As 2024 is coming to an end, Instrumental Home has conducted a statistical analysis of the progress of proton therapy system projects in mainland China (based on public reports), and found that there are already 7 ...
- Source: drugdu
- 846
- January 1, 2025
Huiminbao’s “prisoner’s dilemma”

“Two people in my family were hospitalized, and both had Huiminbao, but not a penny was reimbursed.” When asked whether he would renew Huiminbao, netizen A answered like this. The subtext is: not renewing. It seems to be a very common thing to buy Huiminbao but not get protection. Behind this, it may also be Huiminbao’s helpless move. The nature of universal benefits has led to its extremely wide audience, but in order to avoid losses, Huiminbao has to set a relatively high deductible. In the past, the deductible of some products exceeded 20,000 yuan. However, most of the 20,000 yuan paid out of pocket in addition to medical insurance reimbursement is for major diseases. This also makes Huiminbao look more like major disease insurance, which has little to do with the market’s perception of “benefiting the people”. Of course, there are also Huiminbao with higher compensation rates, but they ...
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- 479
- January 1, 2025
Pioneer in going global, Sinopharm brings good news again. Inflixi, a newly introduced product, has been approved in Indonesia

Recently, Sinopharm (stock code: 688136) introduced its product – Infliximab for Injection (class stop) ®） Successfully approved for listing in Indonesia. The Southeast Asian pharmaceutical market has always been one of Sinopharm’s important advantage markets overseas. The approval of Inflixi in Indonesia further expands the sales area of the drug and provides new treatment options for local patients. Quickly approved for listing, Inflixi’s overseas progress refreshes Infliximab for injection (class stop) ®）， Approved for marketing by the National Medical Products Administration in July 2021, it is the first domestically approved biosimilar drug of Infliximab, mainly used for the treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, adult ulcerative colitis, adult and children over 6 years old with Crohn’s disease and fistula Crohn’s disease. In 2021 and 2022, Sinovac Pharmaceutical and Taizhou Mabotaike Pharmaceutical Co., Ltd. signed agreements to obtain biosimilars of Infliximab (class stop) ®） Commercial rights in over 30 countries ...
- Source: drugdu
- 454
- December 31, 2024
The R&D investment of 26.32 million yuan for external authorization will receive over 500 million yuan in down payment! How was “BD expert” Hengrui Medicine refined?

On the evening of December 29th, Hengrui Pharmaceutical (600276. SH) announced that it has reached an agreement with American biotechnology company IDEAYA Biosciences to license the exclusive rights to develop, produce, and commercialize the Class 1 injectable drug SHR-4849, which has independent intellectual property rights, to IDEAYA Biosciences worldwide for a fee, except for Greater China. Public information shows that SHR-4849 is an antibody drug conjugate (ADC) targeting DLL3, and its payload is a topoisomerase inhibitor (TOPOi). DLL3 is expressed in various solid tumors, including small cell lung cancer and neuroendocrine tumors, but its expression is limited in normal tissues. SHR-4849 exhibits strong proliferative inhibitory activity against different tumor cell lines with high expression of DLL3. SHR-4849 has a significant bystander effect and can kill DLL3 overexpressing cells by releasing toxins. Currently, there are no DLL3 ADC products approved for market worldwide. According to the announcement from Hengrui Pharmaceutical in ...
- Source: drugdu
- 625
- December 31, 2024
The world’s first batch! Daiichi Sankyo’s TROP-2 ADCs have been approved for market launch

On December 27, Daiichi Sankyo announced that its TROP-2 ADC product Datopotamab deruxtecan (Dato DXd, Dedabothumab, trade name: Datoway) was approved for marketing in Japan for the treatment of adult breast cancer patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+or IHC 2+/ISH -), who had received chemotherapy and could not be resected or relapsed. Dato DXd is the first TROP-2 ADC drug approved to treat HR positive and HER2 negative breast cancer in Japan, and also the second ADC drug approved to be developed based on Daiichi Sankyo DXd ADC technology. The drug was jointly developed by AstraZeneca, the First and Third Republics, and has been applied for marketing in the United States (NSCLC, HR+/HER2- breast cancer), the European Union (NSCLC, HR+/HER2- breast cancer), and China (HR+/HER2- breast cancer). This approval is based on data from a key Phase III clinical TROPION-Breast01 study. The TROPION-Breast01 study ...
- Source: drugdu
- 585
- December 31, 2024
Medical Fair Thailand

Organiser：Messe Düsseldorf GmbH Time：September 10 – 12, 2025 Address：88 Bangna-Trad Road (Km.1), Bangna, Bangkok 10260, Thailand Exhibition hall：Bangkok International Trade & Exhibition Centre Product range: Emergency and First Aid Equipment: Hospital Construction and Services, Medical Catering and Kitchen Equipment, Medical Communication and Information Technology, Dental Equipment and Supplies, Diagnostic Equipment and Products Sterilization and Disposal Systems: Electronic Medical Equipment/Medical Technology, Medical Textiles/Laundry, Laboratory Equipment Medical Furniture and Equipment: Medical Consumables, Ophthalmic Supplies, Pharmaceutical Products, Rehabilitation Equipment/Orthopedic Supplies, Services, and Publications, etc. About Medical Fair Thailand： Medical Fair Thailand is one of the most influential medical device exhibitions in Southeast Asia. This exhibition not only serves as a platform for exploring business opportunities in the increasingly growing healthcare industry in Southeast Asia but also provides a window for numerous enterprises to showcase their innovative medical technologies, equipment, and devices.
- Source: drugdu
- 259
- December 31, 2024
Abbott and Dexcom reach settlement on patent for continuous blood glucose detector

On December 23rd, Abbott and Dexcom, the two leaders in the continuous glucose monitoring (CGM) market, reached a settlement agreement regarding their ongoing patent lawsuit. A few weeks ago, the Paris Unified Patent Court made a ruling in favor of Abbott in the patent lawsuit against these two giants. DeKang has filed a lawsuit in court, accusing Abbott and its LibreLinkUp remote analyte monitoring system of infringing on its patents. DeKang Company holDaiichi Sankyo European patent 3 831 282 (EP282). According to the Unified Patent Court, this patent is the core of the ongoing global lawsuit between DeKang and Abbott. However, based on Abbott’s request, the court completely revoked the EP282 patent in all contracting member states in Europe and dismissed all infringement claims made by DeKang based on the patent. 01. Abbott wins in CGM patent dispute A few weeks ago, the Paris Unified Patent Court made a ruling ...
- Source: drugdu
- 601
- December 31, 2024
More and more overseas biotechs want to turn things around with Chinese innovative drugs

Overseas biotechs have played an important role in BD transactions this year. According to statistics from Guosheng Securities, from 2019 to 2023, the proportion of overseas biotechs in domestic BD transaction transferees increased from 14% to 35%. The latest entrant is RAPT Therapeutics. On December 23, it announced the introduction of overseas rights to JYB1904, a long-acting anti-IgE antibody under Jimin Trust, at a cost of an advance payment of US$35 million and future milestone payments of up to US$673 million. IgE is an important target for allergic diseases. Omalizumab has been on the market for more than 20 years, and there is still a lack of more effective iterative drugs. JYB1904 is expected to achieve long-term replacement in the post-omalizumab era. Before the introduction of JYB1904, RAPT was a star player in the CCR4 field. In the field of CCR4 targets, only one macromolecular drug, Mogamulizumab, has been approved ...
- Source: drugdu
- 384
- December 31, 2024

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