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【EXPERT Q&A】How to handle the filing for Class I medical device products?

Drugdu.com expert’s response: The process and requirements for filing Class I medical device products are as follows: I. Filing Process Determine Product Category: Confirm whether the product falls under Class I medical devices by cross-referencing with the “Class I Medical Device Product Catalog” or the “In Vitro Diagnostic Reagent Classification Catalog”. Ensure that the product name, intended use, product description, etc., align with the catalog’s scope. If the product is not listed in the catalog, an application for medical device classification determination must be submitted first. Once it is clarified as a Class I medical device, filing can proceed. Prepare Filing Materials Submit complete filing materials, including but not limited to: Filing Form: Completed and accompanied by an electronic document, requiring the filer’s signature and seal. Safety Risk Analysis Report: Prepared in accordance with the YY 0316 standard, covering the product’s intended use, hazard identification, risk control measures, and validation results. ...
- Source: drugdu
- 101
- May 26, 2025
Health Daily | Rongchang Biotechnology raises HKD 800 million through placement financing; Biotech adjusts development strategy and terminates a research project

Policy Tendence From January to April 2025, the amount of mutual assistance in employee medical insurance personal accounts was 17.792 billion yuan On May 22nd, the National Healthcare Security Administration announced that the mutual assistance of employee medical insurance personal accounts can be achieved through instant calling of the bound person’s personal account, medical insurance wallet transfer, and other methods. From January to April 2025, the personal accounts of employees’ medical insurance assisted 133 million people, with a total amount of 17.792 billion yuan. From the perspective of mutual aid regions, within the same overall planning area (usually the same city), there were 121 million mutual aid visits and a total mutual aid amount of 15.844 billion yuan; Within the province, there were 11.0188 million cross regional mutual aid visits, with a total amount of 1.914 billion yuan. From the perspective of mutual aid purposes, 15.857 billion yuan was used ...
- Source: drugdu
- 106
- May 26, 2025
Tonghua Dongbao plans to transfer a portion of its shares in Tebao Biotechnology through an agreement; Lizhu Group plans to acquire a portion of the equity of IMP, a Vietnamese pharmaceutical company

NO.1 Biotech adjusts BAT3306 development strategy Biotech announced that after a careful evaluation of the company’s drug supervision and management policies and other factors, it plans to adjust the development strategy of BAT3306 (pembrolizumab) and terminate the ongoing BAT3306-002 study on BAT3306 (an evaluation of the combination of BAT3306 and chemotherapy with Credesia) ® A multicenter, randomized, double-blind phase I/III study on the pharmacokinetics, efficacy, and safety of combination chemotherapy in patients with stage IV non-small cell lung cancer. Comment: Biotech’s adjustment of this research and development strategy is based on the fact that the necessity of efficacy comparison studies has greatly decreased when the European and American drug regulatory authorities approve the marketing application of biosimilar products. However, Biotech stated in the announcement that it will carefully evaluate and make a decision on whether to continue advancing the BAT3306 project in the future, reflecting the current fierce competition in ...
- Source: drugdu
- 101
- May 26, 2025
FDA Approves Roche’s Susvimo for Diabetic Retinopathy

The FDA has approved Roche’s Susvimo (ranibizumab injection) 100 mg/mL for treating patients with diabetic retinopathy (DR). The regulatory action makes Susvimo the first and only FDA-approved continuous delivery therapy for DR. What Makes Susvimo a Breakthrough in Diabetic Retinopathy Care? The therapy offers a significant advancement with just one refill every nine months, providing sustained vision benefits in patients who have previously responded to at least two anti-VEGF injections, according to Roche. Approval was based on positive one-year data from the Phase III Pavilion study, which demonstrated superior improvement on the Diabetic Retinopathy Severity Scale (DRSS) and a reduced need for supplemental treatment compared to standard care.1 “The approval of Susvimo for diabetic retinopathy expands treatment options for patients, offering predictable and immediate durability after implantation with only one treatment every nine months,” said Levi Garraway, MD, PhD, chief medical officer, head, global product development, Roche, in a press ...
- Source: drugdu
- 97
- May 26, 2025
FDA Warns of Heart Risk With Pfizer, Moderna COVID Vaccines

THURSDAY, May 22, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) has ordered Pfizer and Moderna to expand their warning labels on COVID-19 vaccines. The updated warnings highlight a rare risk of heart inflammation in teen boys and young men, CBS News reported. The warning applies to males ages 16 to 25 and is based on new data from FDA safety monitoring and a 2023 study. This includes both Pfizer’s Comirnaty and Moderna’s Spikevax vaccines. The updated label will note that “the highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age.” Myocarditis is inflammation of the heart muscle, while pericarditis is inflammation of the lining around the heart. For every million doses in 16- to 25-year-old males, there were 38 cases of these heart conditions, the warning adds. For all people under 65, the rate was about 8 cases per ...
- Source: drugdu
- 112
- May 26, 2025
It is expected that blockbuster vaccine varieties will resume sales growth trend in 2025 under a low base

Xinhua Finance Beijing May 22nd CITIC Construction InvestmentThe research report pointed out that the overall number of vaccine batches issued in the first quarter of 2025 was 697, a year-on-year decrease of 14% .Vaccines, diphtheria, pertussis and hepatitis vaccines increased significantly year-on-year, while polio vaccines, herpes zoster vaccines, rotavirus vaccines and HPV vaccines decreased significantly year-on-year. In terms of research and development, tumor therapeutic vaccines have become a hot area for the expansion of vaccine indications, and domestic research and development is in its infancy; while there are many domestic companies with traditional blockbuster vaccine pipelines, and the competition landscape is becoming fierce. It is expected that in 2025, blockbuster vaccine varieties will resume sales growth on a low base, driving corporate performance improvements. The continuous advancement of innovative vaccine pipelines will bring companies greater market space and potential overseas opportunities in the future. https://finance.eastmoney.com/a/202505223411350774.html
- Source: drugdu
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- May 26, 2025
Moderna withdraws its application for the launch of the new crown/influenza combined vaccine, and its share price fell more than 6% during the session

On Wednesday, Eastern Time, American vaccine manufacturer Moderna announced that it had withdrawn its vaccine for COVID-19 and influenza.The company is considering filing a marketing authorization application for its combined vaccine, pending more efficacy data for its vaccine. Affected by the news, its stock price fell more than 6% during the session. Moderna said it will resubmit its application later this year with effectiveness data from its standalone flu vaccine in a large-scale trial, which is expected to be released this summer. Earlier this month, Moderna claimed, largely as expected, that it did not expect regulators to approve the vaccine until 2026 because more data on its flu vaccine was needed. It is worth noting that the day before Moderna made this decision, the United States tightened the approval requirements for the new crown vaccine. The U.S. Food and Drug Administration (FDA) said that the approval of new crown vaccines ...
- Source: drugdu
- 87
- May 26, 2025
Subsidiary obtains medical device registration certificate

Zhonghong Medical announced on the evening of May 22 that Shenzhen Medrena Biotechnology Co., Ltd., a subsidiary of Zhonghong Pulin Medical Supplies Co., Ltd., recently obtained the ” Medical Devices of the People’s Republic of China” issued by the Guangdong Provincial Food and Drug Administration.The registration certificate for enteral nutrition pump and injection pump medical devices submitted by Medrina has been approved. From January to December 2024, the operating income structure of Zhonghong Medical is as follows: the medical device industry accounted for 100.0%. https://finance.eastmoney.com/a/202505223412056092.html
- Source: drugdu
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- May 26, 2025
Removal bag products are certified by Health Canada to expand overseas market potential

China Securities Intelligence Finance Weili Medical(603309) announced on the evening of May 22 that the company recently received a Class 2 medical device certificate issued by the Canadian Ministry of HealthProduct registration certificate, the company’s product extraction bag (Extraction Bag) has been certified by the Canadian Ministry of Health. 　　This product has two registration certificates because of the differences in design structure and working principle of different models. Product name: Extraction Bag. The certificate numbers are 113343 and 113348 respectively; the models/specifications are Type A (200ml, 400ml, 800ml), Type B (300ml, 550ml, 800ml), and Type C (300ml, 550ml, 800ml). The certification date is May 20, 2025. 　　The announcement stated that the certification obtained from the Canadian Ministry of Health indicates that it can be legally sold in the Canadian market, which will play a positive role in promoting and selling the product in overseas markets. 　　According ...
- Source: drugdu
- 73
- May 26, 2025
Bodybuilding Linked To Sudden Cardiac Deaths

By Dennis Thompson HealthDay ReporterWEDNESDAY, May 21, 2025 (HealthDay News) — Bodybuilders spend countless hours in the gym to create a heart-stopping physique. But their efforts place their own hearts at risk of stopping, a new study says. Sudden cardiac death is responsible for an unusually high proportion of deaths in male bodybuilders, researchers reported today in the European Heart Journal. Further, professional bodybuilders are five times more likely to fall dead from cardiac arrest than amateurs, results show. “The risk of death among male bodybuilders is considerably high,” lead researcher Dr. Marco Vecchiato, a sports medicine specialist at the University of Padova in Italy, said in a news release. “Professional athletes had a markedly higher incidence of sudden cardiac death, suggesting that the level of competition might contribute to this increased risk.” The research was prompted by “a growing number of reports of premature deaths among people involved in ...
- Source: drugdu
- 97
- May 23, 2025

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