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【EXPERT Q&A】What is the process for obtaining a medical device business license?

Drugdu.com expert’s response: Key Point: Only Class III medical devices require a Medical Device Business License. Class I needs no license, Class II only requires filing. Here is the complete process: Step 1: Confirm which class you need Class I (low risk): No license needed, e.g., surgical scalpels, gauze, stethoscopes Class II (medium risk): Business filing only, e.g., thermometers, blood pressure monitors, nebulizers Class III (high risk): License required, e.g., cardiac stents, contact lenses, syringes, CT scanners Note: Starting April 2026, new regulations: individual businesses can no longer apply for Class II or Class III licenses/filings. Applications must be made under a corporate entity (except for individual businesses dealing with 13 specific low-risk Class II products). Step 2: Corporate qualification preparation Register a company. The business scope of the business license must include “Class III medical device distribution.” Statutory processing time: 45 working days; in practice, most regions take 15–20 ...
- Source: drugdu
- 51
- June 5, 2026
Hansoh Pharmaceutical’s GLP-1/GIP Dual-Target Reduction New Drug Application for Market Launch | Industry News

On June 4, Hansoh Pharmaceutical announced that its New Drug Application (NDA) for once-weekly subcutaneous injection of GLP-1/GIP receptor dual agonist ollipopeptide injection has been accepted by the National Medical Products Administration (NMPA) of China. The drug is indicated for long-term weight management in obese or overweight adults. Olepoeptide (HS-20094) is a glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic peptide (GIP) dual receptor agonist independently developed by Hansoh Pharmaceutical . It selectively activates GLP-1/GIP receptors to regulate metabolic pathways related to appetite control, glucose metabolism and energy balance, producing biological effects such as blood sugar control and weight loss. It is administered once a week via subcutaneous injection. According to a press release from Hansoh Pharmaceutical, in March 2026, the first Phase 3 clinical trial (HS-20094-301) of olepiropeptide in overweight or obese adults in China met its primary endpoint. After 48 weeks of treatment with olepiropeptide, the highest average weight loss from baseline ...
- Source: drugdu
- 65
- June 4, 2026
Shijiazhuang Pharmaceutical Group’s Class 2.2 new drug accelerates its domestic market launch

Malignant perivascular epithelioid cell tumor (PEComa) is a relatively rare mesenchymal tumor composed of perivascular epithelioid cells with distinctive histological and immunohistochemical features . This tumor is typically large, with marked nuclear atypia, frequent mitotic figures , tumor necrosis, and invasive growth, exhibiting an aggressive clinical course. Approximately 50% of patients with malignant PEComa are diagnosed at an advanced stage, often with metastasis, resulting in a poor prognosis.On June 3, 2026, according to the latest , the sirolimus for injection (albumin-bound) submitted by CSPC Ouyi Pharmaceutical Co., Ltd. is proposed to be included in the priority review list for the treatment of malignant perivascular epithelioid cell tumor (PEComa). According to a press release from CSPC Pharmaceutical Group, Sirolimus for Injection ( Albumin -Bound ) (HB1901) is a sirolimus albumin-bound nanoparticle suspension for injection. Its active pharmaceutical ingredient (API) is sirolimus, and it is a modified new drug that has not ...
- Source: drugdu
- 65
- June 4, 2026
Lunan Pharmaceutical’s Ningte® isoflurane for inhalation receives marketing approval in Sri Lanka.

Recently , Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a drug registration certificate for Ningte® isoflurane inhalation issued by the National Medicines Agency ( NMRA ) of Sri Lanka . This signifies that the product can be exported to Sri Lanka for commercial sale. Obtaining this approval is an international recognition of the completeness and compliance of the company’s quality system, technical standards, and registration documents. Inhaled isoflurane is suitable for the induction and maintenance of general anesthesia . With its advantages of rapid induction, rapid recovery, and low metabolic rate, it is widely used in various surgeries. Currently, this product is available in China, the United States, and Japan, and registration applications have been submitted in several countries, including Tanzania and Pakistan . The company is accelerating its global supply expansion to provide patients with a safe and effective anesthetic option. During the ...
- Source: drugdu
- 56
- June 4, 2026
Japanese pharmaceutical company’s “COVID-19 prevention drug” receives FDA approval

On June 1, Shionogi & Co., Ltd. of Japan announced that the U.S. FDA had approved its oral antiviral drug XOCOVA (ensitrelvir) for post-exposure prophylaxis against COVID-19. This is currently the first and only oral post-exposure prophylaxis drug approved in the U.S. market. Ensitrelvir is a 3CL main protease inhibitor targeting SARS-CoV-2 , jointly developed by Hokkaido University and Shionogi & Co., Ltd. This drug selectively inhibits the activity of the main protease essential for viral replication, blocking viral amplification in the body. Ensitrelvir is administered orally as a single agent . The FDA approval was based on the results of the global, multicenter, double-blind, randomized, placebo-controlled phase 3 clinical trial SCORPIO-PEP . The study enrolled nearly 2,400 household contacts living with COVID-19 patients in the United States, Argentina, Japan, South Africa, and Vietnam. Participants began taking medication within 72 hours of the index case developing symptoms. Data from the ...
- Source: drugdu
- 58
- June 4, 2026
Bristol-Myers Squibb’s new anticancer drug is proposed to be included in the priority review process

On June 3, the Center for Drug Evaluation (CDE) published a notice on its website stating that Bristol-Myers Squibb’s (BMS) Mezigdomide capsules are proposed for inclusion in the priority review and approval process. The proposed indication is for use in combination with carfilzomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received lenalidomide and anti-CD38 monoclonal antibody therapy. It is understood that this drug was recently granted Breakthrough Therapy designation by the CDE. Multiple myeloma is a difficult-to-cure hematologic malignancy, and even after multiple lines of treatment and achieving remission, almost all patients eventually relapse. With each line of treatment, the patient’s response rate to subsequent therapies and the duration of remission gradually decrease, which is a core challenge in the treatment of multiple myeloma. At the ASCO 2026 Annual Meeting, Bristol-Myers Squibb announced positive breakthrough results from the Phase III SUCCESSOR-2 ...
- Source: drugdu
- 56
- June 4, 2026
Pharmtech Ingredients

Organiser：ITE Group Time：November 24–27, 2026 Address：Crocus-Expo IEC, Krasnogorsk, 65–66 km Moscow Ring Road, Russia Exhibition hall：Crocus-Expo IEC Product range: Pharmaceutical Machinery: Formulation production equipment, pharmaceutical water systems, refrigeration equipment, traditional Chinese medicine processing equipment, etc. Packaging Equipment & Materials: Blister packaging machines, filling machines, tablet press machines, labeling machines, inkjet coders, anti-counterfeiting printing & packaging production lines, barcode composite technology equipment, self-adhesive label printing & packaging equipment, plastic packaging products, container forming-filling-sealing machines, cartoning machines, pouch packaging machines, multi-function bottle packaging machines, glass packaging products & pharmaceutical packaging material production equipment, etc. Laboratory Equipment / Analytical & Testing: Laboratory equipment & instruments, laboratory consumables, chemical reagents, biochemical/analytical instruments, biotechnology analytical & testing instruments, pharmaceutical testing equipment, food analysis & testing instruments, pharmaceutical industry analytical instruments, etc. Fluid Equipment: Sanitary pumps, valves, fluid engineering, pipes & fittings, microfiltration, ultrafiltration, etc. Cleanroom Systems: Cleanroom air conditioning equipment, cleanroom workstations/benches, cleanroom equipment, ...
- Source: drugdu
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- June 4, 2026
【EXPERT Q&A】What certifications are required for the export of medical device products to Russia? How to do it?

Drugdu.com expert’s response: Core Conclusion: To export medical devices to Russia, you must obtain two things — a Medical Device Registration Certificate issued by Roszdravnadzor (Federal Service for Surveillance in Healthcare), and an EAC Certificate of Conformity (COC or DOC). The registration certificate is the prerequisite to sell; the EAC is the customs clearance pass. Both are mandatory. I. What Certifications Are Required 1. National Medical Device Registration Certificate (Most Critical — Must Have) This is a registration certificate issued by Roszdravnadzor (Federal Service for Surveillance in Healthcare). All medical devices (Class 1, 2a, 2b, 3) must have this certificate to be sold in Russia. Without it, import and sale are prohibited. The certificate is typically valid permanently but requires periodic maintenance. 2. EAC Certificate of Conformity (Mandatory for Customs Clearance) Medical devices are high-risk products, so they follow the EAC Certificate of Conformity (COC) pathway, not DOC. Samples must ...
- Source: drugdu
- 65
- June 3, 2026
Chia Tai Tianqing Pharmaceutical Group and Shionogi have collaborated on a major project, Xinpuluo® (Nadimethicone), which has been approved for marketing in China.

On May 29, the official website of the National Medical Products Administration (NMPA) showed that Naldemedine (generic name: Naldemedine tosylate tablets, trade name: Symproic® ) was approved for marketing for the treatment of opioid-induced constipation (OIC) in adults [ 1] . The approval of this innovative drug will provide patients suffering from OIC with a new treatment option to improve their quality of life (QOL) and promote the overall improvement of the level of supportive care for tumors in China. In January 2025, Chia Tai Tianqing Pharmaceutical Group, a core enterprise of China Biopharmaceutical (1177.HK), signed an agreement with Shionogi to obtain the exclusive marketing rights of Naldemedine in mainland China. Nadecamide is the world’s first approved oral selective peripheral μ-opioid receptor antagonist. By blocking the binding of opioids to μ receptors in the intestine, it directly restores the normal peristaltic rhythm and intestinal fluid secretion function, thus reversing the ...
- Source: drugdu
- 73
- June 2, 2026
The first domestically produced HER2 bispecific antibody! Anituzumab from KNJ Pharmaceutical and CSPC Pharmaceutical Group has been approved for marketing

On May 28, the NMPA announced that it had approved the marketing of Anituzumab Injection (trade name: Enituzumab) submitted by Shanghai Jinmante Biotechnology through the priority review and approval procedure. This product, in combination with chemotherapy, is indicated for the treatment of locally advanced or metastatic HER2-positive adult patients with gastric or gastroesophageal junction adenocarcinoma who have previously received at least one trastuzumab-containing therapy . Anitumumab (KN026) was originally developed by KNJ Biopharma as a HER2 bispecific antibody that binds to two non-overlapping epitopes of HER2, blocking HER2 signaling. It enhances ADCC and CDC effects through antibody-induced receptor aggregation while downregulating cell surface HER2 receptors. In August 2021, KN026 was licensed to CSPC Pharmaceutical Group for a total transaction value of RMB 1 billion. Its wholly-owned subsidiary, Shanghai Jinmante Biotechnology, obtained exclusive rights to develop and commercialize KN026 in mainland China for breast cancer and gastric cancer indications. In November ...
- Source: drugdu
- 70
- June 2, 2026

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