Medical Device Shipments During the COVID-19 Pandemic
COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.
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INDIA OFFICIALLY REQUIRES REGISTRATION OF ALL NON-NOTIFIED DEVICES
On February 11th, 2020 the Ministry of Health and Family Welfare published the Medical Device Rules, 2020 as an amendment to the Medical Device Rules
INDIA TO REQUIRE REGISTRATION OF ALL CURRENTLY NON-NOTIFIED DEVICES
Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate
Update: INDIA SETS REGISTRATION DEADLINE FOR ULTRASOUND EQUIPMENT
India’s Central Drugs Standards Control Organization (CDSCO) has officially added ‘ultrasound equipment’ to the Notified list of medical devices that require pre-market approval in India.
4 Product Development Decisions that Impact Sales Performance in Asia
US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.
INDIA COMPLIANCE MAINTENANCE: NOTIFIED BODY CHANGE
Given recent conditions of Brexit, many companies are impacted with changes regarding their notified body. This change ultimately changes the CE Mark on labeling, thus requiring amendments to any existing Import Licenses in India.
INDIA PLANS TO REGULATE ALL MEDICAL DEVICES
The CDSCO review process to generate a MD Form 15 typically takes 6 to 9 months with 6 to 8 weeks of application preparation. To be safe, manufacturers should begin the MD Form 15 application process 12 months before any deadline.
Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate and Import License.
India to Regulate Surgical Drapes and Gowns
Surgical drapes and gowns have been added to the Indian list of notified medical devices. Manufacturers of these devices should take urgent action to prepare registration applications to maintain access to the Indian market.
INDIA MOVES QUICKLY TO REGULATE ORGAN PRESERVATION SOLUTION
This Notification announcement represents a departure from the anticipated process to add devices to those that require registration in India. Manufacturers of currently non-Notified devices should be vigilant about pending registration requirements.