Expert Q&A – Page 9 – media

【EXPERT Q&A】Can medical devices be contracted for production?

Drugdu.com expert’s response: Medical devices can indeed be entrusted for production, but strict compliance with relevant regulatory requirements is essential. Below is a detailed analysis: I. Regulatory Basis and Fundamental Requirements According to the Regulations on the Supervision and Administration of Medical Devices and related supporting documents, medical device registrants and record-holders (hereinafter referred to as “registrants”) may entrust qualified enterprises to manufacture medical devices. The core principle of entrusted production is that registrants bear primary responsibility for the quality and safety of the products, while the entrusted party must organize production in accordance with regulations, standards, and the entrustment agreement, and accept supervision from the registrant. II. Key Restrictive Conditions Prohibited Entrusted Production Catalog: High-risk implantable medical devices (such as cardiac pacemakers, artificial joints, etc.) are not allowed to be entrusted for production. The specific catalog is formulated and dynamically adjusted by the National Medical Products Administration (NMPA). Given the direct implantation ...
- Source: drugdu
- 150
- June 4, 2025
【EXPERT Q&A】How should accelerated tests be carried out in drug stability studies?

Drugdu.com expert’s response: Accelerated testing is a crucial method for assessing the stability changes of pharmaceuticals under short-term high-temperature and high-humidity conditions. It helps predict stability trends under long-term storage conditions and provides a basis for determining the shelf life and storage conditions of drugs. Below are the detailed steps and key points for conducting accelerated testing: I. Purpose of the Test The primary objective of accelerated testing is to accelerate the degradation or deterioration process of drugs within a relatively short period by elevating storage temperature and humidity conditions, thereby evaluating the stability of the drugs. II. Test Conditions Temperature: Typically, 40℃±2℃ is selected as the temperature condition for accelerated testing. This temperature, higher than the routine storage temperature, can expedite the degradation reactions of drugs. Humidity: The relative humidity is usually set at 75%±5%. High humidity conditions are beneficial for assessing the sensitivity of drugs to moisture. III. ...
- Source: drugdu
- 175
- June 2, 2025
【EXPERT Q&A】What is the development history and mechanism of action of mRNA drugs?

Drugdu.com expert’s response: The development of mRNA (messenger RNA) drugs has undergone a journey from early exploration to technological breakthroughs, and then to widespread application. The specific progression is as follows: I. Early Exploration (1961-1990) In 1961, scientists first discovered mRNA. In 1987, Malone found that mRNA molecules mixed with lipid droplets could enter cells and express the desired protein, marking the beginning of RNA research as a therapeutic agent. In 1990, scientists injected in vitro-transcribed messenger RNA (mRNA) into mice and discovered that it could be expressed in vivo, producing relevant proteins in a dose-dependent manner. This method of directly injecting mRNA could induce an immune response by expressing specific proteins, serving as the prototype for mRNA therapy. II. Technological Breakthroughs (Early 21st Century-2020) Entering the 21st century, mRNA synthesis, modification, and delivery technologies further advanced. In 2005, Karikó and Weissman discovered that using modified nucleotides like pseudouridine could ...
- Source: drugdu
- 155
- May 30, 2025
【EXPERT Q&A】Do domestic Class II medical devices need to be registered in the ASEAN countries where they are exported?

Drugdu.com expert’s response: Domestic Class II medical devices exported from China to ASEAN countries generally require registration in the target country, although specific requirements vary depending on each country’s regulations and the risk classification of the product. Below is a detailed analysis: I. Overview of Medical Device Registration Requirements in ASEAN Countries ASEAN countries, including Singapore, Malaysia, Thailand, Indonesia, the Philippines, Vietnam, etc., have varying regulatory requirements for medical devices. However, most countries require imported medical devices to be registered or filed in their domestic markets to ensure compliance with local regulations and standards. These requirements typically include submitting product technical documentation, quality inspection reports, clinical trial data (if applicable), etc., and may necessitate completing the registration process through a local authorized representative or importer. II. Country-Specific Requirements Examples Singapore: The regulatory authority for medical devices is the Health Sciences Authority (HSA) of Singapore. Imported medical devices must comply with HSA’s registration ...
- Source: drugdu
- 219
- May 28, 2025
【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
- 191
- May 26, 2025
【EXPERT Q&A】What are the standards and procedures for compliance review?

Drugdu.com expert’s response: Compliance review is an essential task undertaken by enterprises or organizations to ensure that their business activities adhere to legal and regulatory requirements, industry norms, and internal rules and regulations. The standards and procedures for compliance review vary depending on factors such as industry, region, and enterprise size, but they typically encompass the following core elements: I. Standards for Compliance Review Legal and Regulatory Requirements Applicable Laws: These include national laws, administrative regulations, and local regulations, such as the Company Law, Labor Contract Law, and Environmental Protection Law. Industry Regulations: These are specific regulatory requirements for particular industries, such as anti-money laundering regulations in the financial sector and privacy protection laws in the medical industry. International Treaties or Agreements: When engaging in cross-border business, enterprises must comply with international conventions or bilateral agreements (e.g., GDPR requirements for cross-border data flows). Internal Rules and Regulations of the Enterprise ...
- Source: drugdu
- 143
- May 23, 2025
【EXPERT Q&A】How effective is tirpotide?

Drugdu.com expert’s response: Tirzepatide demonstrates remarkable efficacy in both glucose-lowering and weight reduction, with favorable safety profiles and positive effects on overall metabolic health. However, attention should be paid to individual differences and potential adverse reactions. Below is a detailed analysis of its effects: Glucose-Lowering Effects: Tirzepatide is a dual agonist of the GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide) receptors. By enhancing insulin secretion, inhibiting glucagon release, and delaying gastric emptying, it significantly reduces blood glucose levels. Clinical trials have shown that tirzepatide can substantially lower glycosylated hemoglobin (HbA1c) levels, aiding patients in better blood glucose control and reducing the risk of diabetes-related complications. Weight Reduction Effects: Tirzepatide exhibits outstanding efficacy in weight loss. It significantly reduces body weight by delaying gastric emptying and suppressing central appetite. In a clinical trial involving obese or overweight non-diabetic patients, the high-dose (15mg) tirzepatide group achieved an average weight loss of ...
- Source: drugdu
- 133
- May 21, 2025
【EXPERT Q&A】Are imported drugs really more effective than domestic ones? Why?

Drugdu.com expert’s response: Imported drugs are not absolutely more effective than domestic drugs. The difference in their efficacy is influenced by multiple factors, including drug type, research and development (R&D) technology, formulation processes, and individual patient variations. A comprehensive assessment based on specific circumstances is necessary. Below is a detailed analysis: I. The Difference in Drug Efficacy is Not Absolute Common Diseases: For common illnesses such as colds and coughs, there is little difference in efficacy between domestic and imported drugs. For example, domestic paracetamol has been widely recognized for its antipyretic and analgesic effects and is more cost-effective. Chronic Diseases: In the treatment of chronic diseases requiring long-term medication, such as hypertension and diabetes, imported drugs may offer better patient compliance due to their precise formulations and superior side effect management. However, domestic drugs that have passed consistency evaluations are equally reliable in terms of efficacy and safety. Complex ...
- Source: drugdu
- 582
- May 19, 2025
【EXPERT Q&A】How to view the compliance of pharmaceutical companies’ records?

Drugdu.com expert’s response: Record compliance in pharmaceutical enterprises is a core element in safeguarding drug quality, ensuring patient medication safety, and maintaining corporate reputation and market competitiveness. The following provides an in-depth analysis from the perspectives of importance, influencing factors, challenges, and coping strategies: I. The Importance of Record Compliance in Pharmaceutical Enterprises Regulatory Compliance and Legal Liabilities: Pharmaceutical companies must strictly adhere to regulations such as the “Drug Administration Law” and “Good Manufacturing Practice (GMP).” Record compliance is a core requirement of regulatory oversight. Inaccurate or missing records may expose enterprises to severe consequences, including hefty fines, product recalls, or even license revocation. Drug Quality and Safety Assurance: Complete and accurate records form the basis for traceability throughout the entire drug production process. For instance, the compliance of records related to raw material procurement, production processes, and inspection data directly impacts whether drug quality meets standards. Any missing records in any环节 ...
- Source: drugdu
- 152
- May 16, 2025
【EXPERT Q&A】What materials should be submitted for the registration of Class III medical devices within the country?

Drugdu.com expert’s response: The registration of domestic Class III medical device products in China requires the submission of application materials to the National Medical Products Administration (NMPA). Specifically, the process is handled through its subsidiary, the Center for Medical Device Evaluation (CMDE), which is responsible for the technical review of medical device product registrations. Below is a detailed explanation: I. Submission Authority The registration materials for domestic Class III medical device products must be submitted to the National Medical Products Administration (NMPA). As the competent authority overseeing medical device regulation in China, the NMPA is responsible for the registration approval, quality supervision, and market regulation of medical devices. The Center for Medical Device Evaluation (CMDE), a subsidiary of the NMPA, specifically undertakes the technical review of medical device product registrations. II. Submission Process Preparation of Registration Materials Applicants must prepare a complete set of registration application materials in accordance with ...
- Source: drugdu
- 218
- May 14, 2025

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