Expert Q&A – Page 10 – media

【EXPERT Q&A】When exporting Class I medical devices, should they be declared for non-medical or medical use?

Drugdu.com expert’s response: The declaration of Class I medical devices as non-medical or medical depends on the specific use of the device and the regulations of the target market. Typically, Class I medical devices refer to low-risk medical equipment, such as surgical instruments and some diagnostic devices. In most cases, these devices are categorized as medical because they are used directly or indirectly for the diagnosis, prevention, monitoring, treatment, or alleviation of diseases. However, if the same type of device is intended for non-medical purposes (for example, solely for cosmetic or personal care), it may be classified as non-medical. In such cases, the classification should be determined based on the actual use of the device and the regulations of the target market. Therefore, when declaring, you should consider the following factors: Purpose of the Device: Is the main use of the medical device for medical or non-medical purposes (such ...
- Source: drugdu
- 156
- February 15, 2024
【EXPERT Q&A】What is the process for exporting medical devices to the UAE?

Drugdu.com expert’s response: The specific steps and requirements for exporting medical devices to the UAE include: Product Compliance Assessment: Ensure that the medical device complies with the specific standards of the UAE, including safety, efficacy, and quality control. Obtain international certifications such as the CE mark or FDA approval. Registration with the UAE Ministry of Health: Submit an application for medical device registration to the UAE Ministry of Health. This includes submitting detailed documents such as product descriptions, safety and efficacy data, and technical files. Choosing an Authorized Agent: Select an authorized agent in the UAE responsible for handling registration, import, and distribution matters. Ensure that the agent has a legal operating license and a good market reputation. Labeling and Instructions for Use: The product labels and instructions for use should meet the language requirements of the UAE (usually in Arabic and English) and include necessary product information such as ...
- Source: drugdu
- 226
- February 12, 2024
【EXPERT Q&A】What are the steps in the FDA’s drug approval process?

Drugdu.com expert’s response: The drug approval process by the FDA is quite standardized and rigorous. Here’s a detailed breakdown of the entire process: Preclinical Studies: This is the first step in the drug approval process, involving pharmacological and toxicological studies to assess the drug’s safety and efficacy. These studies are usually conducted in laboratories or animal models. Submission of an Investigational New Drug Application (IND): Once preclinical studies indicate that the drug might be safe, pharmaceutical companies submit an Investigational New Drug application (IND). The IND includes preclinical study data, manufacturing information, and clinical trial protocols. Clinical Trials: This is the core part of the drug approval process and mainly consists of three phases. Phase I primarily tests the drug’s safety and dosage in humans; Phase II focuses on the drug’s efficacy and side effects; Phase III further confirms efficacy, monitors side effects, and compares the drug with existing treatments. ...
- Source: drugdu
- 154
- February 8, 2024
【EXPERT Q&A】What are the classifications of pharmaceutical intermediates?

Drugdu.com expert’s response: Pharmaceutical intermediates are one or more chemical substances generated during the drug synthesis process, playing a crucial role in the production of the final Active Pharmaceutical Ingredient (API). The variety of pharmaceutical intermediates depends on the chemical structure and synthesis pathway of the target drug. Here are some common types of pharmaceutical intermediates: Benzene Ring Intermediates: Many drugs, especially anticancer and cardiovascular drugs, are based on the benzene ring structure. Heterocyclic Compounds: Such as pyridine, thiophene, imidazole, etc., commonly used in pharmaceutical manufacturing. Amino Acids and Peptides: They are the foundation of many bioactive molecules and drugs, like insulin. Carboxylic Acids and Their Derivatives: Often used in the synthesis of anti-inflammatory drugs and antibiotics. Esters and Ethers: Utilized in the synthesis of various drugs, including painkillers and sedatives. Sulfur Compounds and Thioethers: Play an important role in the synthesis of certain special drugs. Aldehydes and Ketones: Key intermediates ...
- Source: drugdu
- 138
- February 5, 2024
【EXPERT Q&A】What documents and certifications are needed, and what are the main processes for exporting pharmaceuticals to Canada?

Drugdu.com expert’s response: Exporting pharmaceuticals to Canada requires adherence to specific processes and regulations. Here are the key steps for exporting pharmaceuticals to Canada: Understanding Canadian Regulations: Before exporting, familiarize yourself with the pharmaceutical regulations and regulatory requirements of Canada. Health Canada is the regulatory authority responsible for formulating and enforcing policies on drug imports. Familiarity with these regulations is essential to ensure that the exported pharmaceuticals comply with Canadian standards. Registration and Approval: Pharmaceuticals must be registered and approved by Health Canada before export. Depending on the type of drug, different application forms and materials may be required. Specific requirements can be found on Health Canada’s official website: https://www.canada.ca/en/health-canada.html Quality Management in Drug Production: Ensure that exported pharmaceuticals meet Canadian Good Manufacturing Practices (GMP). Exporting companies should regularly conduct internal audits to ensure compliance with GMP standards. Product Labeling and Instructions: Pharmaceutical labels and instructions must be prepared according ...
- Source: drugdu
- 198
- February 1, 2024
【EXPERT Q&A】What are the procedures for exporting medical devices to Japan?

Drugdu.com expert’s response: Given your company’s plans to enter the Japanese market and previous export experience, we will skip the details on export qualifications. To market their products in Japan, medical device companies must comply with Japan’s Pharmaceutical and Medical Device Act (PMD Act). However, language barriers and complex certification processes pose challenges in the registration of medical devices in Japan. Under the PMD Act, the TOROKU registration system requires domestic manufacturers to register factory information with the government-authorized local authority, including product design, production, and key process information. Foreign manufacturers must register their manufacturing information with the PMDA (Pharmaceuticals and Medical Devices Agency). Process for PMDA Registration: 1.1 Preparation Stage. Determine the product classification (Class I, Special Control Class II, Class II, Class III, Class IV) and product JMDN code, select a Japanese Marketing Authorization Holder (MAH). 1.2 The manufacturer registers the factory with PMDA. 1.3 Class II Special Control ...
- Source: drugdu
- 221
- January 29, 2024
【EXPERT Q&A】Which in vitro diagnostic medical devices are required to be assessed by EURLs for export to the EU, and what are the specific reference laboratories involved?

Drugdu.com expert’s response: For the export of in vitro diagnostic (IVD) medical devices to the European Union, certain types of products may require assessment or testing by designated European Union Reference Laboratories (EURLs). These reference laboratories mainly focus on high-risk in vitro diagnostic medical devices, particularly those closely related to public health. The types of IVD products typically evaluated by EURLs include: Infectious Disease Diagnostic Devices: For detecting major infectious diseases such as HIV, Hepatitis B, and Hepatitis C. Blood Screening Devices: Used for blood safety testing, such as devices for detecting pathogens in blood. High-Risk Cancer Biomarker Diagnostic Devices: For detecting high-risk biomarkers of certain types of cancer. Genetic Disease Diagnostic Devices: For detecting specific genetic diseases or susceptibilities. The EU designated reference laboratories include: ECDC (European Centre for Disease Prevention and Control): Responsible for the detection and control of infectious diseases. EURL for Blood Borne Infections: Specifically responsible ...
- Source: drugdu
- 131
- January 25, 2024
【EXPERT Q&A】How to Start a Medical Device Trading Company?

Drugdu.com expert’s response: Medical trade, encompassing international exchanges of goods and services in the healthcare sector, is a distinct kind of commerce. Like other commodities, the trade of medical services includes both imports and exports. The essence of medical service trade lies in the local export of goods and services, characterized by its comprehensive and integrative nature. a. Local Export of Goods In countries or regions providing medical facilities, expenses incurred by international patients and their families for medical care, food, accommodation, transportation, tourism, shopping, and entertainment are paid in foreign currency. This method of generating foreign exchange revenue essentially represents a form of local export trade, realized through the provision of medical services on-site. b. Local Export of Services Apart from purchasing and consuming medical material products, patients and their families also utilize various service-related activities, as medical products inherently involve a significant proportion of service labor. For example, the ...
- Source: drugdu
- 224
- January 16, 2024
【EXPERT Q&A】What are some well-known medical equipment trade shows in the Latin American region?

Drugdu.com expert’s response: In the Latin American region, several notable medical equipment trade shows attract industry professionals from around the globe. These events provide excellent opportunities for showcasing new technologies, networking with industry leaders, and gaining insights into the latest market trends. Some of the prominent trade shows in the Latin American medical equipment sector include: Hospitalar: Held in São Paulo, Brazil, Hospitalar is one of the most significant healthcare fairs in Latin America, offering a comprehensive showcase of medical equipment, hospital furniture, pharmaceutical products, and more. Meditech: This trade show takes place in Bogotá, Colombia, and focuses on medical technology and healthcare solutions, drawing exhibitors and attendees from various countries. Expo Med: Located in Mexico City, Mexico, Expo Med serves as a key event for medical device and supply professionals in Mexico and Central America, featuring a wide range of medical products and equipment. FIME (Florida ...
- Source: drugdu
- 143
- December 27, 2023
【EXPERT Q&A】What documents are needed and what is the specific process for exporting medical equipment?

Drugdu.com expert’s response: Exporting medical equipment requires a thorough understanding of the regulatory requirements of both the exporting and importing countries, and involves several steps and essential documents: 1.Regulatory Compliance Compliance with Exporting Country Regulations: Ensure the medical equipment meets the regulatory standards of the country of origin. Compliance with Importing Country Regulations: Understand and comply with the medical device regulations of the destination country, which may include certifications like CE Marking (for Europe) or FDA approval (for the United States). 2.Essential Documents Export License: Depending on the type of equipment and the destination, an export license may be required. Commercial Invoice: Details the transaction between the exporter and importer. Packing List: Describes the contents and packaging details of the shipment. Bill of Lading or Airway Bill: Used for the shipment of goods. Certificate of Origin: States where the equipment was manufactured. Product Certifications: Documents like CE Certificate or FDA ...
- Source: drugdu
- 177
- December 22, 2023

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