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【EXPERT Q&A】‌‌What are the mandatory core requirements for NMPA registration materials of Class II active medical devices?

Drugdu.com expert’s response: When enterprises apply for domestic registration of Class II active medical devices, they need to focus on demonstrating the product’s safety, effectiveness and quality controllability. Compared with some passive medical devices, active products usually involve functions such as power supply, circuits, software, control systems and energy output. Therefore, in the registration review process, electrical safety, electromagnetic compatibility (EMC), software verification and product performance are the key areas of concern. In accordance with the Regulations on Administration of Medical Device Registration and Filing of the National Medical Products Administration (NMPA) and Announcement No. 121 of 2021, domestic Class II medical devices are subject to registration review and approval by the provincial drug regulatory department where the enterprise is located, while imported Class II medical devices are reviewed and approved by the NMPA. The registration application materials shall be prepared in accordance with the specified catalogue and format, and the technical ...
- Source: drugdu
- 44
- October 26, 2026
Rotigotine Transdermal Patch Receives Drug Registration Certificate, Expanding Its Parkinson’s Treatment Portfolio

On October 26, Fuyuan Pharmaceutical (601089) announced that it had received a Drug Registration Certificate from the National Medical Products Administration (NMPA) for its rotigotine transdermal patch (strengths: 2 mg/24 hours and 4.5 mg/patch), approving the manufacture of the product. The rotigotine transdermal patch is indicated for monotherapy of the signs and symptoms of early-stage idiopathic Parkinson’s disease, or in combination with levodopa at all stages of the disease. Rotigotine is a non-ergot dopamine receptor agonist. The transdermal patch delivers the drug continuously and steadily through the skin, helping to maintain stable plasma concentrations, reducing the peak-trough fluctuations common with oral dosing and improving morning motor symptoms. It is particularly suitable for patients with dysphagia or those requiring continuous overnight dosing. According to the announcement, the company’s cumulative R&D investment in this product amounted to RMB 15.7779 million. The approval will further enrich the company’s product pipeline and help enhance ...
- Source: drugdu
- 52
- October 26, 2026
Qilu Pharmaceutical’s Changqiping® inhaled spray approved for market launch, adding a new option for maintenance treatment of COPD

Recently, Qilu Pharmaceutical’s tiotropium bromide inhalation spray (Changqiping® ) was approved for marketing by the National Medical Products Administration. It is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD, including chronic bronchitis and emphysema) and related dyspnea, improving the quality of life of COPD patients and reducing acute exacerbations. This approval represents another breakthrough for the company in the high-barrier drug-device combination field, further enriching its respiratory system product pipeline and providing new treatment options for clinical practice. COPD is a heterogeneous lung disease characterized by persistent airflow limitation and corresponding respiratory symptoms. Its core pathological changes include small airway lesions and lung parenchymal destruction. The main symptoms include chronic cough, sputum production, shortness of breath, or dyspnea. In my country, the prevalence of COPD is severe, becoming one of the major chronic diseases seriously endangering national health, alongside hypertension and diabetes. The prevalence of COPD in ...
- Source: drugdu
- 55
- October 26, 2026
First generic version of a novel pulmonary arterial hypertension treatment drug approved for marketing.

On October 22, 2026, according to the latest information on the official website of the National Medical Products Administration (NMPA) of China, the beraprost sodium sustained-release tablets submitted by Beijing Tide Pharmaceutical Co., Ltd. were approved for marketing. It is mainly used to treat pulmonary hypertension and improve symptoms such as ulcers, intermittent claudication, pain and coldness caused by chronic arterial occlusive disease.Pulmonary hypertension is a cardiovascular disease with high rates of disability and mortality. Patients experience progressively increasing pulmonary vascular load, eventually leading to heart failure. Idiopathic pulmonary arterial hypertension (IPAH), which has been included in my country’s first batch of rare disease catalogs, is an important type of PAH. Research data shows that without targeted treatment, the median survival of IPAH patients after the onset of symptoms is only 2.8 years.According to publicly available information, beraprost sodium is the world’s first oral prostacyclin (PGI2) derivative . It has ...
- Source: drugdu
- 44
- October 26, 2026
Another global medical device giant has officially announced its spin-off!

According to recent foreign media reports, Abbott announced the spin-off of its businesses and a downward revision of its full-year guidance after releasing its Q3 results. Abbott announced plans to spin off its nutrition business into an independent company by the end of 2027. The new independent company will have annual sales of $8.5 billion, 16,000 employees, and 14 manufacturing sites. Its product portfolio will include well-known brands such as Ensure (a nutritional supplement drink), PediaSure (a pediatric nutritional supplement), Glucerna (a diabetes management nutrition brand), and Similac (an infant formula brand). Daniel Salvadori, the current Executive Vice President and Group President of Mature Pharmaceuticals and Nutrition Products, will become the CEO of this independent company. The spin-off plan includes Abbott distributing shares of the independent nutrition company to Abbott shareholders. Upon completion of the spin-off, Abbott shareholders will hold shares in both Abbott and the independent nutrition company. It ...
- Source: drugdu
- 48
- October 26, 2026
Nobel Prize-winning company lays off 90% of its staff

Recently, Caribou Biosciences announced the termination of development of all its clinical pipelines, large-scale layoffs, and the initiation of a strategic review that includes mergers, acquisitions, and asset sales. Under California’s WARN Act, Caribou will lay off 87 employees, effective December 7. The company had 97 full-time employees as of February 27, 2026, meaning the layoffs will affect approximately 90% of its workforce . Caribou’s co-founders include Jennifer Doudna, a pioneer of CRISPR gene editing technology and the 2020 Nobel Prize laureate in Chemistry; the company was also one of the first to bring CRISPR to clinical application. From Nobel Prize Labs to Nasdaq In 2011 , Jennifer Doudna’s Berkeley lab had just unveiled the CRISPR-Cas9 gene-editing tool when she and her PhD student, Rachel Haurwitz, co-founded Caribou Biosciences, with venture capital firm Atlas Venture providing $11 million in seed funding. In 2014, Caribou, along with Atlas Venture, spun off ...
- Source: drugdu
- 54
- October 26, 2026
Methionine raw material passes South Korea’s MFDS inspection

Tianjin Pharmaceutical Co., Ltd.On the evening of October 23, the company issued a statement saying that it had recently received the results of a GMP on-site inspection from the Korean Ministry of Food and Drug Safety (MFDS). From September 8th to 10th, Tianjin Pharmaceutical Group’s production base located at No. 19, Xinyejiu Street, West Zone, Tianjin Economic-Technological Development Area, received methionine raw material.The site underwent GMP inspection and passed the Korean MFDS requirements with “zero defects”. Methionine, an essential amino acid for the human body, is a core raw material for various amino acid infusions and compound amino acid preparations. Clinically, it is used as an adjunct treatment for chronic hepatitis and cirrhosis, as well as a supportive treatment for toxic liver disease. Industry insiders believe that the scope of this inspection focused on methionine raw materials , and passing with “zero defects” means that the company’s quality system, production ...
- Source: drugdu
- 48
- October 26, 2026
Clinical trial application submitted to the US FDA for ASC39 oral tablets for the treatment of obesity.

People’s Finance News, October 26th – Ascletis Pharma announced on the Hong Kong Stock Exchange that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its ASC39 oral tablets. ASC39 is an oral, small-molecule selective amylin receptor agonist used to treat obesity. The company expects to initiate a Phase I trial in the fourth quarter of 2026. Source: https://finance.eastmoney.com/a/202610263907436177.html
- Source: drugdu
- 39
- October 26, 2026
【EXPERT Q&A】‌‌With a large number of main products, which items should an enterprise prioritize for overseas promotion?‌

Drugdu.com expert’s response: When many pharmaceutical and medical device enterprises start overseas promotion, they will encounter a common problem: there are dozens or even hundreds of products in the company’s product catalog, but which ones should be prioritized for key promotion on B2B platforms? Some enterprises are used to uploading all their existing products, believing that the more products they list, the higher the chance of being searched by overseas buyers. Others directly select several best-selling products in the domestic market, assuming that items performing well at home will surely meet demands in overseas markets. Both ideas are reasonable to a certain extent, but more factors need to be taken into account in actual overseas procurement scenarios. Whether a product can attract buyers’ attention is related not only to market demand, but also to the enterprise’s supply capacity, product documentation, target market access status and peer competition. A Large Product ...
- Source: drugdu
- 73
- October 23, 2026
【EXPERT Q&A】‌To what extent should an enterprise prepare when overseas buyers inquire whether products can support local registration?‌

Drugdu.com expert’s response: When conducting foreign trade in pharmaceuticals and medical devices, some overseas buyers, after confirming product specifications and prices, will further ask: “Can you support product registration in our country?” This question may seem straightforward to suppliers. If an enterprise holds relevant certificates such as GMP, CE, or ISO 13485, or has past export experience, it can easily reply directly that it can support registration. However, the “registration support” mentioned by buyers may involve far more work than just providing a few certificates. Especially for pharmaceuticals, APIs and medical devices, there are significant differences in registration pathways, application entities, technical documents and approval requirements across different countries. The fact that a supplier can provide product materials does not mean these materials already meet local registration requirements; nor does the fact that a product has been approved for marketing in one market mean it can directly enter another. What Are ...
- Source: drugdu
- 108
- October 23, 2026

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