Royal Cert India

Janakpuri, Delhi

However, the fda can also cause serious financial consequences as well as irrevocable damages on the corporate image if not complied within a timely manner. Particularly the last year's imports alone, the fda had refused more than 15, 500 products from abroad, and this strict screening process is expected to continue. Medical device manufacturers seeking food and drug administration (fda) approval to sell their products in the united states. One of the first steps for medical device companies who manufacture class 2 medical devices (and a small number of class 1 and 3 devices) is to file a premarket notification, also known as a fda 510(k) submission, with the food and drug administration. Technically, the fda does not "approve" class 1 and 2 medical devices for sale in the us; they give "clearance" for them to be sold. To be cleared for sale by the fda, the first step is to identify a predicate device(s), which is a medical device already cleared by the fda and is similar to the one for which fda approval is being sought. in general, manufacturers introducing class 2 medical devices to the us must submit a 510(k) to the fda. A 510(k) is also required for manufacturers changing the intended use of their medical device, or changing the technology of a cleared device in such a way that it may significantly affect its safety or effectiveness.

Haccp is standa for hazard analysis and critical control points. Faced with the risk of large-scale toxic infection, the latest food crises, the increased life span of products and the lengthening of the food chain, hypermarkets, supermarkets and certain countries have developed private sector schemes (ifs for the french and germans, brc for the british) based on the haccp method to guarantee the safety of their own-brand products. But questions soon arose regarding harmonisation via an internationally recognised standard framework that would allow everyone in the food chain, and not just those in the food processing sector, to offer consumers safe products. haccp is built around seven principlesanalysis of food hazards: biological, chemical or physicalidentification of critical control points: raw materials, storage, processing, distribution and consumptionestablishment of critical control limits and preventive measures: for example, minimum cooking temperature and timemonitoring of these critical control pointsestablishment of corrective actionskeeping recordsestablishing a systematic and regular auditing of the system in place by independent third party certification bodies. benefits of implementing haccphaccp can be applied throughout the food chain from the primary producer to final consumer :haccp reduces the need for finished product testing by identifying the hazards associated with the inputs into the process and the product and devising control measures which can be monitored in order to minimize or eliminate the hazards. Haccp will significantly reduce the chance of microbiological, chemical, and physical contaminants from reaching the customer. Haccp can reduce regulatory involvement (and hence costs) by replacing on-line inspection with regular auditing. Haccp principles can be applied to other aspects of food quality and regulatory requirements.