How you can introduce new cosmetics and new medical device in India

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In India introduction of any new medical device requires approval from Government. In the same way cosmetic things also before introduction in the market have to go through stringent process for approval.In this article we will discuss about medical device regulation in India and rules to follow for cosmetics import.

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+91 7672005050 + 65 31630390 contactcliniexperts.com How you can introduce new cosmetics and new medical device in India In India introduction of any new medical device requires approval from Government. In the same way cosmetic things also before introduction in the market have to go through stringent process for approval. In this article we will discuss about medical device regulation in India and rules to follow for cosmetics import. In India one of the biggest industries is the cosmetics industry that is expanding at a very rapid rate and its size is double the size of the market in US and Europe. Keeping an eye the rate at which the industry is expanding it is necessary to ensure that the products that are being introduces are safe for use. Therefore Ministry of Health and Family Welfare in India has formulated rule that a registration certificate is required for cosmetics import in India. So if you have any plan to start a

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+91 7672005050 + 65 31630390 contactcliniexperts.com cosmetic business in India then you must know that there are certain guidelines you need to follow. Let’s have a discussion on those guidelines in details. At first you should know who are eligible for Cosmetics Import India Well as per the regulations set by Ministry of Health and Welfare India the cosmetic manufacturer should have a registered office in India. An authorized agent or a

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+91 7672005050 + 65 31630390 contactcliniexperts.com subsidiary agent of the manufacturer can also start Cosmetic Import India. How to register for cosmetics imports in India The cosmetics that are imported should be registered with the Central Drug Standards Controller India under the Ministry of Health and Family Welfare. All you have to do is fill up the application form and submit to the Central Drug Standards Controller of India both in form of hard copy as well as in electronic form. Along with that it is also necessary to submit application in a prescribed form42 with a cover letter. It is the receipt for original payment of the registration fees. The office of the Drug Controller General of India will provide a duly signed copy of the cover letter that acts as an acknowledgement. The registration certificate is issued within 6 months of submitting the application. This registration certificate is valid for about 3 years after which a renewal is needed for continuing the business. What are the documents required for registration

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+91 7672005050 + 65 31630390 contactcliniexperts.com  All details about manufacturer as well as the manufacturing unit that includes the name contact information address and the full address of the manufacturing unit.  A valid Import Export code.  Proof for payment of registration fees.  Details about the cosmetics that is to be registered. It includes the brand name manufacture date pack size etc.  All details about the manufacturing license and the marketing authorization under which cosmetics are being manufactured.  The countries list where the product has been granted permission.  Detail name of the ingredients of the cosmetics according to the international nomenclature.  All methods of testing and specification of the product.  A label specimen.  Detail information if the product is sold in India and the time period of its selling period.

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+91 7672005050 + 65 31630390 contactcliniexperts.com Medical device regulation in India Medical devices are being widely used across the globe in all branches of medicines surgery and community including India. For ensuring protection of the health safety of patients as main objective the Ministry of Health Family Welfare Government of India has released the Medical Device Rules 2017 MDR 2017 effective from 1st January 2018 for regulating Medical Devices being used in the country. After publication of MDR 2017 the Indian medical device regulatory framework has now become stringent. These rules have been drafted with the objective of distinguishing medical devices from pharmaceuticals for the purpose of regulation. The regulatory bodies responsible for Medical Device Registration India are:

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+91 7672005050 + 65 31630390 contactcliniexperts.com  The Central Drug Standards Control Organization CDSCO under Directorate General of Health Services in Ministry of Health and Family Welfare Government of India is the National Regulatory Authority NRA responsible for approval of manufacturing import conduct of clinical trials laying down standards sale and distribution of medical devices through enforcement and implementation of the Medical Devices Rules 2017.  The Drug Controller General of India DCGI shall be the Central Licensing Authority responsible for enforcement of rules in matter pertinent to import of all Classes of medical devices.  Drugs Cosmetic Act 1940 Rules 1945are responsible for manufacturing import sale and distribution of medical devices. In India there are more than 500 medical device and in vitro diagnostic medical devices which are required to be registered before they are intended for marketing in India.

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+91 7672005050 + 65 31630390 contactcliniexperts.com CliniExperts serves as an authorized Indian agent and provides end to end solution right from product classification and its respective documentation submission labelling requirements follow ups and obtaining the permissions.

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