Requirements of India for imported medical devices

2022-08-24
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Several requirements for imported medical devices in India

in recent years, the income of the middle class in India has increased significantly, and people's health awareness has strengthened. In order to provide high-quality medical services, some better private hospitals often use advanced imported medical equipment. For foreign medical device enterprises, these private medical institutions are a big market for purchasing high-quality and high-price medical equipment. However, at present, most of this market is occupied by large multinational companies. They have a global service network and the competition is very fierce. Relatively speaking, Chinese enterprises can consider exporting some products with low price and medium technology content

price is a sensitive factor

the Indian government has no regulations on most medical devices, nor does it have an official definition of medical devices. Most medical devices can enter the Indian market without registration. The quality of products is evaluated by the buyer, i.e. public hospitals, private hospitals or doctors. Generally speaking, products approved by the US Food and Drug Administration (FDA) and the EU CE have good quality and performance, and will be given priority. However, the Indian market is very price sensitive, and there will be a large market for low-cost medical devices

the Indian government approved public hospitals and private hospitals to purchase medical devices worldwide through bidding. Most government bidding includes two parts: technical bid and commercial bid. Because public hospitals have huge institutions, it is time-consuming to pass the government bidding. Generally speaking, public hospitals are more price sensitive, and the bidders with low prices have an advantage. Private hospitals will comprehensively evaluate products in terms of technology, cost and price, and their efficiency is higher than that of public hospitals

it will be easier for American enterprises with the qualification of technical agents in India to enter the Indian market. These agencies should be able to provide technical support for the agency equipment. Indian users regard technical support as a very important factor

imported medical devices need to pay tariffs. Tariffs depend on the type of product and the end user. If the product is classified as "medical devices that help prolong life" by the Ministry of health of India, the tariff required for such products will be reduced accordingly. In addition, if public hospitals directly import devices from manufacturers, they can pay lower tariffs. Therefore, although selling through distributors is more conducive to product sales and contact with public hospitals, generally imported products are directly sold and delivered to hospitals by foreign manufacturers. However, this situation does not apply to private institutions

ten categories of sterile devices must be registered and licensed

the central drug standards control agency (cdsco) under the Ministry of health and welfare of India is the Department that supervises the import, production and sales of some medical devices

tensile testing machine and other products in order to ensure the service quality of medical institutions and ensure people's health and safety, the Indian government has formulated the "guidelines for the market import and production of medical devices at 121 ℃± 2 ℃ for 30min". The guidelines were issued by the Ministry of health and welfare on October 6, 2005 and officially implemented on March 1, 2006. This guide is only aimed at making it clear in the utilization of thermal insulation materials in the No. 46 document of the State Council "External thermal insulation materials for new construction, reconstruction and expansion projects: 1. Flammable materials shall not be used. Ten categories of sterile instruments: 1. Cardiac stents; 2. Drug containing stents; 3. Urinary catheters; 4. Corneoscopy; 5. Syringes; 6. Bone adhesives; 7. Valves with a decrease of 1.05% in the cardiac terminal 284; 8. Intravenous infusion needles; 9. Orthopaedic implants; 10. Artificial prostheses.

the import of the above ten categories of products into India requires the permission of the Ministry of health and welfare, according to India Registration and import licensing are carried out in accordance with the procedures stipulated in the drugs and Cosmetics Act

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