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Morulaa Medical Product Approval and Distributor Selection

WEBMorulaa is a turnkey solution provider with an in-house regulatory team to conduct registrations of medical device (MD - 14), IVDs, cosmetics, drugs (Form 41, Form 43) in India by following CDSCO. On completing the CDSCO regulation requirements, our marketing team gets involved in the Distributor Selection process. Our regulatory and …

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"Vicks Action 500" Banned by Indian Health Ministry

WEBThe content of the product is a standard dose of paracetamol, phenylephrine and caffeine, which has been banned by health ministry of India on issuing a notice at the end of previous week, the health care giant passed the information to the stock exchange. To know more about the medical news in India – Morulaa.

Category: Medical Go Health

Morulaa Healthtech Pvt Ltd

WEBIndia Specific Device Classification and Government Fees at One Click. Search for your Device with a single click and Find what would be the Government, Regulatory Pathway, and Classification (A, B, C, and D) as per the Regulatory Authority of India. Click here for Free Subscription. -.

Category: Health Go Health

South Korea Medical Device Registration

WEBThe main steps for product approval by Korea’s Ministry of Food and Drug Safety (MFDS) are: Step 1: Appointing a license holder/ distributor under whose name the application for product approval will be made. Step 2: Having the medical device tested at the MFDS verified laboratories. Step 3: Submission of the technical file to the MFDS

Category: Food, Medical Go Health

Medical Devices (……Amendment) Rules, 2021

WEBIn the Medical Device Rules of 2017, in Rule 7, after the words “the International Electro Technical Commission (IEC),” the following words shall be inserted “ or American Standard Test Method (ASTM)” . This rule came into effect on 5th […]

Category: Medical Go Health

CDSCO Drug Recall Guidelines: Ensuring Compliance and Safety

WEBThis article referring to CDSCO/RRAS Ver.:00 dated 23/11/2012, talks about the essential components of an effective recall system with the procedure to be followed in India and how Morulaa can help manufacturers and importers manage these challenges in case of any product recall. In the highly regulated healthcare device industry, which is overseen by …

Category: Health Go Health

Thailand HealthCare Market Overview Morulaa

WEB87% of medical devices and equipment used by hospitals is imported into Thailand. X-rays and scanner equipment alone contributed over US $80 million in 2006. Other medical equipment commonly imported into Thailand are nebulizers, infusion systems, fetal monitors, ECG equipment, and autoclaves. The medical device market including …

Category: Medical Go Health

Regulation of Biologics in India

WEBThe ‘Similar biologics’ are regulated under the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945 for the manufacture, use, import, export and storage of harmful microorganisms or genetically engineered organisms or cells, Rules, 1989 notified under the Environment (Protection) Act, 1986. Applicable Guidelines.

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