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The Holiday Healer, Plot No. 38, Rajeswari Street, Kandanchavadi, Chennai (2026)

20/01/2018

In India, In -Vitro Diagnostic kits/reagents are regulated under the provisions of the Medical Device Rules, 2017. IVD’s are defined as substances intended to be used outside human or animal bodies for the diagnosis of any disease or disorder in human beings or animals covered under sub-clause (i) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 and IVDs that are notified, from time to time, as a device under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940. [ 7,511 more words ]

IVD kits/reagents are regulated under the provisions of the Medical Device Rules, 2017

08/11/2017

The Government of India is planning to develop an in-depth regulatory framework for medical devices and IVDs registration. These are regulated under the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), part of Health and Family welfare of India. The regulatory structure for medical devices in India is under the Drugs and Cosmetic Act of 1940, and Drugs and Cosmetic Rules of 1945. [ 921 more words ]

Recent Important Notifications by CDSCO, SUGAM Updates for medical devices registration in india with regulatory approval

07/09/2017

In India, medical devices are regulated by CDSCO under the control of Drug Controller General of India (DCGI). All medical devices in India is following a regulatory framework that is based on the drug regulations under the Drugs and Cosmetic Act (1940) and Drugs and Cosmetic Rules (1945). The Health Ministry of India has published new medical device and IVD regulations to replace the country’s Drugs and Cosmetics Act for creating effective regulatory structure. [ 10,731 more words ]

http://www.morulaa.com/uncategorized/medical-devices-rules-2017-classification-of-medical-devices-old-backup-abishek/

In India, medical devices are regulated by CDSCO under the control of Drug Controller General of India (DCGI). All medical devices in India is following a regulatory framework that is based on the drug regulations under the Drugs and Cosmetic …

24/07/2017

On 1st January 2017, India's Ministry of Health and Family Welfare released the” Medical Device Rules, 2017”, which will come into force January 1, 2018. This regulation will replace the country’s Drugs and Cosmetics Act for creating effective regulation. As per the guidelines, in vitro diagnostic (IVD’s) used for diagnosis are classified based on their level of risk as follows: [ 7,469 more words ]

http://www.morulaa.com/cdsco/medical-devices-rules-2017-classification-of-ivds/

The Indian Health Ministry has published a draft on list of in vitro diagnostics along with their risk class

19/07/2017

In India, medical devices are regulated by CDSCO under the control of Drug Controller General of India (DCGI). All medical devices in India is following a regulatory framework that is based on the drug regulations under the Drugs and Cosmetic Act (1940) and Drugs and Cosmetic Rules (1945). The Health Ministry of India has published new medical device and IVD regulations to replace the country’s Drugs and Cosmetics Act for creating effective regulatory structure. [ 10,732 more words ]

http://www.morulaa.com/cdsco/medical-devices-rules-2017-classification-of-medical-devices/

In India, medical devices are regulated by CDSCO under the control of Drug Controller General of India (DCGI). All medical devices in India is following a regulatory framework that is based on the drug regulations under the Drugs and Cosmetic …

08/02/2017

On February 2, 2017 The Ministry of Health and Family Welfare has announced Medical Devices Rules, 2017 that separates regulatory norms for manufacturing medical devices from drugs. The rules will come into effect from January 1, 2018. This new rules is to regulate medical devices in the country to ease norms for manufacturing medical devices in the country and to promote domestic industry. [ 284 more words ]

http://www.morulaa.com/news/10091-indian-govt-notifies-new-norms-to-regulate-medical-devices/

On February 2, 2017 The Ministry of Health and Family Welfare has announced Medical Devices Rules, 2017 that separates regulatory norms for manufacturing medical devices from drugs. The rules will come into effect from January 1, 2018. This new rules …

09/12/2016

The Indian Ministry of Health and Family Welfare published a draft of Medical Device Rules, 2016 which are classified medium to high risk IVD devices under the new ivd classification system will require CDSCO (Central Drugs Standard Control Organization) registration certificate or license. The current regulations has only 23 types of medical devices and IVD require registration and so this regulatory draft represents a significant change to the regulatory requirements for most medical device manufactures selling or intending to sell in India. [ 962 more words ]

Under the Indian medical device rules, 2016 by CDSCO, the In–vitro Diagnostics or IVD classification system has 4 groups, ranging from Class A to Class D...

08/12/2016

Maharashtra Food and Drug Administration (FDA) has directed all 306 blood banks in the state to submit applications of renewal of licenses by 31st December 2016 to carry out timely inspections and approvals. There are around 53 blood banks in the state for which renewals are pending. As stated in Drugs and Cosmetics Rules, 1945 blood bank licenses are valid for 5 years. [ 322 more words ]

Maharashtra Food and Drug Administration (FDA) has directed all 306 blood banks in the state to submit applications of renewal of licenses by 31st December 2016 to carry out timely inspections and approvals. There are around 53 blood banks in …

08/12/2016

Indian syringes and needles market is expected to grow at a CAGR of 15% by 2020. This growth is mainly because of India’s large pool of patients, increase in healthcare expenditure, increase in healthcare awareness and rising government spending. Syringes and needles market in India is dominated by imported products including products produced by imported material which comprises approximately 75% of the total revenue. [ 157 more words ]

Indian syringes and needles market is expected to grow at a CAGR of 15% by 2020. This growth is mainly because of India’s large pool of patients, increase in healthcare expenditure, increase in healthcare awareness and rising government spending. Syringes …

02/12/2016

The Ministry of Health’s Food Safety Standards Authority of India has come out with quality and safety standards to regulate the standards and quality of health supplements, nutraceuticals, food (special dietary care, medicinal purpose, functional food and novel foods) and has sought public comments on the same. The effective date for the new rules is November 24. Dr DBA Narayana, a leading scientist and industry expert told use of medicinal plants both as drugs and foods are now gaining importance. [ 261 more words ]

http://www.morulaa.com/news/10088-fssai-drafts-safety-regulations-for-nutraceuticals-food-supplements/

The Ministry of Health’s Food Safety Standards Authority of India has come out with quality and safety standards to regulate the standards and quality of health supplements, nutraceuticals, food (special dietary care, medicinal purpose, functional food and novel foods) and …

01/12/2016

The Indian Ministry of Health issued a set of new guidelines on 17 October, 2016 called “The Medical Device Rules, 2016” to define and regulate medical devices as a separate category. This move is to develop an in-depth regulatory framework for medical devices. The new guidelines will make medical device regulations stringent for both manufacturing and importation of medical devices. [ 1,084 more word ]

http://www.morulaa.com/cdsco/forms-and-purposes-the-medical-device-rules-2016/

According to the CDSCO's new medical device rules, 2016 the various informations and required forms and their purposes is being detailed

01/12/2016

On Monday, Indian food safety watchdog the Food Safety and Standards Authority of India (FSSAI) announced that health supplements cannot be sold as medicines at all and also fixed the permissible limits of various ingredients used in the products. New standards have been issued for manufacturers of the products to check mislabelling. The Food Safety and Standards Authority of India has operationalised with immediate effect new standards for 8 categories of products including health supplements and nutraceuticals. [ 277 more words ]

http://www.morulaa.com/news/10087-fssai-proposes-new-rules-for-health-supplement-misabelling/

On Monday, Indian food safety watchdog the Food Safety and Standards Authority of India (FSSAI) announced that health supplements cannot be sold as medicines at all and also fixed the permissible limits of various ingredients used in the products. New …

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