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【EXPERT Q&A】How long does it take to obtain a medical device registration certificate for exporting Chinese medical devices to Malaysia?

Drugdu.com expert’s response: The time required to obtain an MDA medical device registration certificate for exporting Chinese medical devices to Malaysia mainly depends on the product risk class and whether an expedited pathway is used. Standard Processing Time (No Expedited Pathway) Under Malaysia’s Medical Device Act 2012, products are classified into four risk categories: Class A (Low Risk): e.g., gauze bandages, medical rubber plaster, cooling oil → 6–9 months Class B (Moderate-Low Risk): e.g., povidone-iodine solution, disposable sterile obstetric surgical pack → 9–12 months Class C (Moderate-High Risk): 12–18 months Class D (High Risk): 18–24 months Expedited Pathway: As Fast As 30 Working Days This is currently the most notable channel. Malaysia and China have launched a regulatory cooperation program. Products holding a China NMPA registration certificate can apply through the MDA Verification Pathway via a CAB (Conformity Assessment Body) assessment, shortening the approval time to approximately 30 working days. Eligibility: hold NMPA / CE / FDA / TGA registration from ...
- Source: drugdu
- 161
- June 10, 2026
QMEE QINGDAO

Organiser：Asia Economic & Trade Development Promotion Center, China Council for the Promotion of International Trade Shandong Provincial Committee, Qingdao Medical Association Time：July 2–4, 2026 Address：Qingdao International Convention and Exhibition Center, No. 9 Miaoling Road, Laoshan District, Qingdao Exhibition hall：Qingdao International Convention and Exhibition Center Product range: Diagnostic & Treatment Equipment: X-ray imaging, ultrasound diagnostics, endoscopy systems, monitoring equipment, scanning devices, optical instruments, and examination/diagnostic equipment for neurology, orthopedics, ENT, ophthalmology, pathology, etc. Laboratory: Testing instruments, laboratory equipment, biochemical analysis & diagnostic reagents, sterilization & disinfection equipment, cleanroom engineering, gas supply systems, cryogenic & freezing equipment, etc. Rehabilitation & Nursing: Various therapeutic devices, rehabilitation training equipment, nursing instruments, special mobility aids, barrier-free facility series, healthcare equipment, assistive devices. Digital Healthcare: Intelligent examination & checkup devices, Medical Image Archiving & Communication System (PACS), Hospital Information System (HIS), digital community healthcare systems, telemedicine systems, healthcare information solutions, medical software development, electronic medical ...
- Source: drugdu
- 204
- June 9, 2026
Jingfang Pharmaceuticals’ small molecule drug receives Fast Track designation from the US FDA for lung cancer

On June 5th, GenFang Pharmaceuticals announced that GFH375/VS-7375 ( an oral KRAS G12D inhibitor ) received Fast Track Designation (FTD) from the U.S. FDA for the treatment of previously treated patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with KRAS G12D mutations (concurrent or sequentially treated with platinum-based chemotherapy and PD-1/PD-L1 inhibitors) . Previously, GFH375/VS-7375 received another Fast Track Designation from the FDA last year for the treatment of first-line and later-line KRAS G12D -mutant metastatic pancreatic ductal adenocarcinoma (PDAC). Furthermore, GFH375 has already received two Breakthrough Therapy Designations (BTD) in China this year for monotherapy in KRAS G12D -mutant advanced pancreatic cancer and NSCLC. GFH375 is an orally administered, highly active, and selective small-molecule KRAS G12D (ON/OFF) inhibitor. It binds to the KRAS G12D protein non-covalently, inhibiting its binding to downstream effector proteins, thereby disrupting the sustained activation of downstream pathways by KRAS G12D in ...
- Source: drugdu
- 177
- June 8, 2026
Once a month! The world’s first new drug for IgA nephropathy has been approved for marketing in China.

Yesterday (June 4), the official website of the National Medical Products Administration (NMPA) showed that Otsuka Pharmaceutical’s application for Sibeprenlimab injection was conditionally approved for marketing, for the treatment of adult patients with primary immunoglobulin A nephropathy (IgAN) to maintain their kidney function. This application had previously been included in the priority review list. Sbelimab is the world’s first approved monoclonal antibody drug targeting the inhibition of proliferation-inducing ligand (APRIL) . Its approval in China marks a new stage in the treatment of IgA nephropathy in China, moving from traditional supportive care to precise intervention targeting upstream causes. 01 IgA nephropathy is highly prevalent and difficult to treat. IgA nephropathy is the most common primary glomerular disease in China, with a patient population of over 2.2 million. The disease is concentrated in young adults aged 16 to 40 and is the leading cause of progression to end-stage renal disease (uremia) ...
- Source: drugdu
- 208
- June 8, 2026
The world’s first Class 1 new drug from a Guangdong pharmaceutical company has been approved for marketing

Mantle cell lymphoma (MCL) combines the highly progressive nature of aggressive lymphoma with the incurable nature of indolent lymphoma. Most patients are diagnosed at an advanced stage, often with involvement of lymph nodes, bone marrow, gastrointestinal tract, and extranodal organs. The successive availability of previous generations of BTK inhibitors has significantly improved patient prognosis, but drug resistance and relapse remain a major challenge to long-term survival. On June 4, 2026, according to the latest information on the official website of the National Medical Products Administration (NMPA) of China, the Class 1 innovative drug lobrutinib tablets submitted by Guangzhou Lupeng Pharmaceutical Co., Ltd. was approved for marketing . The drug is indicated for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two systemic therapies (including Bruton’s tyrosine kinase [BTK] inhibitors) . According to publicly available information, lobubrutinib is the world’s first fourth-generation covalent ...
- Source: drugdu
- 146
- June 8, 2026
GenSci Pharmaceutical’s self-developed Class 1 new drug has been approved for clinical trials for two indications, covering pediatrics and neurology.

Recently, GenSci155 injection, independently developed by Changchun GenSci Pharmaceutical Co., Ltd. (hereinafter referred to as “GenSci Pharmaceutical”), has been approved by the National Medical Products Administration to conduct clinical trials. It is intended for the prevention of bronchopulmonary dysplasia (BPD) in premature infants and the treatment of acute ischemic stroke (AIS). GenSci Pharmaceutical will subsequently conduct further clinical research in the fields of pediatric health and neuroprotection. GenSci155 injection is a long-acting fatty acid-conjugated recombinant human insulin-like growth factor-1 (IGF-1) analogue, registered as a Class 1 therapeutic biological product. Developed based on GenSci Pharmaceutical’s Duratide™ long-acting sustained-release peptide platform, this product achieves reversible binding to albumin through fatty acid chain modification, prolonging the drug’s half-life in vivo. It supports both intravenous and subcutaneous administration, extending dosing intervals and contributing to stable and adequate drug exposure. Indication 1 Prevention of bronchopulmonary dysplasia (BPD) in premature infants Bronchopulmonary dysplasia (BPD) is the most common pulmonary ...
- Source: drugdu
- 149
- June 8, 2026
Yunnan Baiyao Group’s Central Research Institute’s INB301 injection IND has received FDA clinical trial approval, achieving a milestone breakthrough with “dual applications in China and the United States”

On June 2, 2026, the innovative biological drug INB301 injection, developed by the Central Research Institute of Yunnan Baiyao Group (hereinafter referred to as the “Central Research Institute”), officially obtained Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). Previously, the product had received clinical trial approval from the China National Medical Products Administration (NMPA) on March 30, 2026. The consecutive successful clinical reviews by the drug regulatory agencies of both China and the United States for INB301 injection marks a key advancement for Yunnan Baiyao in its global innovative drug strategy, achieving a significant breakthrough in “dual application” between China and the U.S.Aligning with international standards and setting a new benchmark for Sino-US dual reporting”Dual application in China and the US” is an important indicator of an innovative pharmaceutical company’s R&D strength and its ability to align with international standards. The fact that INB301 injection ...
- Source: drugdu
- 423
- June 8, 2026
【EXPERT Q&A】What are the document requirements and review difficulties for applying for CE in in vitro diagnostic (IVD) self-testing?

Drugdu.com expert’s response: IVD Self-testing products are classified as Class C under IVDR by default (except for urine glucose/red blood cell/white blood cell/bacteria tests, which are Class B). About 80% of IVD products require Notified Body (NB) review, and self-testing products are almost all in this category. The documentation volume is large, the review cycle is long (Class D can take 18–24 months), and the core difficulties focus on usability studies, clinical performance evidence, and IFU label compliance. I. Mandatory Documentation Checklist 1. Technical Documentation (core, approximately 20+ items) Table of contents (version status, cross-references); manufacturer name and address, product name (all models/specifications), product description (intended use, model list, photos, drawings); device sample identification, declaration of conformity; list of applicable standards, essential requirements checklist (Annex I); risk management report (EN ISO 14971); product history (sales, complaints, change records); manufacturing method (production flowchart); quality control process description (incoming/in-process/final inspection, batch release ...
- Source: drugdu
- 162
- June 8, 2026
Cinda leads the world, and Takeda’s 1.2 billion gamble is reaping the rewards.

On June 4 local time, Innovent Biologics announced that its pivotal Phase III clinical trial of IBI343 (generic name arcotatug tavatecan, Takeda code name TAK-921), a CLDN18.2-targeted ADC drug developed in deep collaboration with Takeda Pharmaceutical, has met its primary endpoint. An arrow incrementally going up stairs before pointing straight up. Blue backgroundMeanwhile, China’s National Medical Products Administration (NMPA) has formally accepted IBI343’s marketing application and included it in the priority review process , making it the world’s first CLDN18.2-targeted ADC to enter the regulatory review stage . Just one year after Takeda acquired the overseas rights to the drug for $1.2 billion last year, Innovent has once again solidified its leading position in the global ADC field with solid clinical data. I. Key results of Phase III clinical trial: Excellent efficacy and manageable safety. The Phase III clinical trial announced this time is an international multicenter study covering China ...
- Source: drugdu
- 162
- June 5, 2026
The National Medical Products Administration (NMPA) conditionally approved the marketing of Pometamethasone Alpha for injection.

Recently, the National Medical Products Administration (NMPA) conditionally approved the marketing of Pometrazyne Alpha for Injection (trade name: Bojia Ning) submitted by Jiangsu Bejitech Biotechnology Co., Ltd. through the priority review and approval procedure. It is indicated for the treatment of bleeding in adult patients with congenital hemophilia A or B who have an inhibitor of coagulation factor VIII or IX >5 Bethesda units (BU). The marketing of this product provides a new treatment option for these patients . https://mp.weixin.qq.com/s/Y059ZMm7OwCt2Y6y9d5Aqw
- Source: drugdu
- 137
- June 5, 2026

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