medical device – media

【EXPERT Q&A】What are the regulations and requirements for exporting medical devices to the European Union?

Drugdu.com expert’s response: Entering the European Union market requires medical device products to adhere to a series of stringent regulations and quality standards. Firstly, products must obtain CE certification, a mark that signifies compliance with EU requirements for safety, health, and environmental protection. Before submitting an application, make sure that all relevant application forms are completed in detail, including key data such as product specifications and manufacturer information. Upon passing preliminary review, the product will be sent to an EU-designated third-party certification body for comprehensive and accurate testing and evaluation. This body will assess the product’s compliance with the EU Medical Device Directive (MDD) or Medical Device Regulation (MDR), depending on the case. After successfully completing the certification process, you will receive EU export product certification, an indispensable credential proving that your product can be legally sold in the EU market. It should be noted that due to the wide variety ...
- Source: drugdu
- 543
- September 5, 2023
European Union medical device regulations
【EXPERT Q&A】What is the procedure for registering medical devices for the Russian market?

Drugdu.com expert’s response: The registration process in Russia mainly consists of the following steps: Submission of Application: First, you need to submit a registration application to the Russian Ministry of Health. This typically includes detailed information about your product such as the name, type, specifications, manufacturer information, etc. Technical Documentation Review: The Russian Ministry of Health will review the technical documentation you have submitted. This might encompass details of your product design, production process, quality control systems, etc. Clinical Evaluation: You might be required to undergo a clinical evaluation to demonstrate the safety and efficacy of your product. This could involve clinical trials or submission of other forms of clinical data. Manufacturer Review: The Russian Ministry of Health might review the manufacturer to ensure compliance with Russian laws and regulations. Obtaining the Registration Certificate: If your product passes the above steps of the review, you will receive a registration certificate. ...
- Source: drugdu
- 571
- August 22, 2023
medical device Russia market
Things to Know before Buying Newborn Baby Incubators

A baby incubator is the most vital devices in every pediatric and obstetrics hospital as it provides a warm and safe environment for newborns and specifically for premature or sick babies who require special care.
- Source: Ddu
- 6,851
- March 31, 2022
baby incubators medical device Researches
Portable Nebulizer Machine

An asthma attack comes unannounced and leaves the unsuspecting patient distraught. In such situations, a portable nebulizer machine can prove to be a boon to the patient, preparing him/her for emergencies. Moreover, asthma patients are prescribed periodical doses of medications and hence, a portable nebulizer machine can be handy if and when they are travelling. The portable nebulizer machine available on Ddu (Drugdu.com) is manufactured by Changzhou zhengyuan medical technology Co., Ltd.which is proficient in the manufacture of mesh nebulizers. The Chinese nebulizer machine supplier/ manufacturer offers its light-weight, battery/electricity-powered nebulizer to customers at Ddu. This nebulizer can be used with ease with one smart button. It includes different mesh size plates to regulate the particle size. It functions at a safe working power of 1.5W. It does not produce noise which makes it an ideal choice for use during travel without disturbing neighbouring people. It has a unique feature ...
- Source: drugdu
- 1,754
- September 10, 2018
medical device
PHYSIOTHERAPY TABLE

As the name suggests, examination table / treatment table is a kind of specialized bed where the patient is made to lie down conveniently so that it would be easier for the physician to diagnose the patient’s condition and treat accordingly. Same way, physiotherapy table is used for performing physiotherapy exercises, which includes massage and traction. These tables are segmented into normal and electric type. These physiotherapy table wholesale beds should be very strong to lift up till 225 kg with minimal maintenance. The stainless steel type backrest should be adjustable to any angles from 0 to 70 degrees according to the convenience of the physicians. Even the height can also be adjusted from 48cm to 90cm. In electric table, the hand switch will be available. Our drugdu team has collaborated with the physiotherapy table manufacturer / supplier named Huangshan Jinfu Medical Equipment Co., which was established in ...
- Source: drugdu
- 1,386
- September 7, 2018
medical device
BIOPSY FORCEPS

Biopsy forceps is a basic surgical instrument used widely in gastrointestinal endoscopy units. They have difference in shape and diameter of closed jaw, effective working length, with or without spike and coating. They are of two types: Disposable and Reusable. Disposable biopsy forceps have started replacing the reusable ones in many parts of the world. Disposable biopsy forceps are more preferred since they drastically reduce the risk of transmission and cross-contamination. They are convenient with the decreased reprocessing rate. But the cost factor plays a significant role. This is where our drugdu team enters into the scenario. By collaborating with biopsy forceps manufacturers/suppliers like Sculape India, Hunan Handlike Minimally Invasive Surgery Co., Ltd in China and Alton (Shanghai) Medical Instruments Co., Ltd., Ddu have compiled a varied list of cost effective disposable biopsy forceps wholesale, according to the healthcare needs. Sculape India was established in the year 1980. ...
- Source: drugdu
- 1,258
- September 7, 2018
medical device
Basic Info about Digital Thermometers

A basic indispensable device in a doctor’s clinic, the thermometer has come a long way since its invention in 1714 to serve the purpose of calculating temperature. Fevers being a common presentation of many diseases, a thermometer is required quite often in hospitals and clinics.
- Source: Ddu
- 3,819
- September 3, 2018
digital medical device Researches thermometer
Global Recall of CyPass Micro-Stent by Alcon

A micro-invasive surgical device named CyPass Micro-Stent used for the treatment of glaucoma was globally recalled by Alcon, a subsidiary of Novartis. The stent was supposed to be used in combination with cataract surgery but the company announced an immediate recall.
- Source: The Verdict
- 737
- September 3, 2018
Company Insight FDA medical device recall
What are Pulse Oximeters & their uses?

Pulse Oximetry is a non-invasive technique to measure the oxygen saturation in a person’s blood. Put simply, it tells you whether your heart is pumping enough oxygen to all parts of your body. A pulse oximeter is designed to be clasped to a peripheral organ like the earlobe, toe or finger, but is most commonly used on the fingers.
- Source: Ddu
- 1,366
- August 30, 2018
medical device Researches
Wright Medical and Orthopaedic Devices Manufacturer Cartiva sign $435m Deal

Medical Devices companies Wright Medical Group and Cartiva signed a $435 million cash-based contract wherein the Netherlands-based firm will avail all the outstanding shares of the Osteoarthritis focused US-based firm.
- Source: The Verdict
- 1,062
- August 29, 2018
Company Insight medical device Orthopaedics

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