Most of them are counted from the factory date, which is the date of the final packaging, but in fact it should be counted from the sterilization. Take a simple example, for example, a bread sterilization date is January 1, 2010 (of course, you do not know when this is sterilized), its date of manufacture is also the final packaging date is January 5, 2010, the expiration date is 6 months. So, its expiration date is counted from January 5, 2010 to June 4, 2010 is the expiration date of this bread. You must be asking, that's only 5 days between January 1, 2010 and January 5, 2010, if the expiration date is 6 months, wouldn't it be out of the expiration date by June 5, 2010, and not edible. You have to realize that the amount of some mold they use in making the bread won't be specific to just a few days, just as you found out after June 4, 2010 that the bread is actually not out of date and can still be eaten. In fact, all the products are almost a program, not because of just a few days and spoilage variable (of course, in addition to the expiration date of only a few days, in addition), the reason why he has an expiration date time or because in case there are any quality problems, the manufacturer side will have a responsible time period. It is impossible to say that the bread put 3 years, stale, you go to the manufacturer, the manufacturer is still responsible for. You said that the date of receipt of material into production, is another matter, for example, you need to make bread butter and flour, that is, the expiration date of the flour and butter, they are made into bread, is baked, they are from one ingredient into another, the expiration date can not be counted in accordance with the original. But for example, the expiration date of the cream, if the expiration date of the bread is 6 months, then the cream to make bread must be about 6 months of storage time, because you still have to place a period of time before making bread right.
How is a medical device-active product defined?In layman's terms, an active product is one that requires electricity to operate
How do I get CE marking for a medical device?Medical device certification
TOPMEN, in conjunction with the notified body SNCH, provides comprehensive medical device product certification services for domestic enterprises to meet the European Union CE requirements, and we will make full use of our international platform to provide more comprehensive services for medical device companies.
We use different certification modes to provide certification services for manufacturers of different medical device products, services include:
1. product classification determination
2. enterprise technical file assistance
3. enterprise management assistance
4. product testing
5. factory audit (when applicable)
6.6. CE certificate issuance
Background
1. UK-based global multinational enterprise; with offices in 56 countries worldwide and over 30,000 registered customers of all types;
2. Asia-Pacific headquarter is located in Shanghai, providing customers with fast, professional and trustworthy services;
3. Technical experts have been involved in the research and development of European regulations for decades.
3. Technical experts have been involved in the research and development of European regulations for a long time and have decades of experience in product and system certification, providing customers with one-stop solutions;
4. Certified products cover a wide range of different categories of medical devices, and the number of certified customers is more than 300;
5. Open and fair certification process ensures that customers can monitor the whole process.
Testing and auditing
At present, we have localized the testing and auditing, that is, all the testing and auditing will be carried out in the country by domestic staff, which can save the cost of the enterprise and the testing cycle
How to do medical device agentThis is relatively simple, generally do the agent is required, depending on what channels you sell. Offline and online are different
How to be a medical device brand agent?Medical equipment agents, like Shandong Mintai a class of regular manufacturers generally require:
Complete licenses, and normal annual inspection (business license, tax registration certificate, organization code certificate, business license, etc.);
The company has a certain strength, (this is crucial, now many manufacturers are engaged in distribution, you can do a few hospitals to authorize a few hospitals to do)
The company has a certain strength, (this is crucial, now a lot of manufacturers are engaged in distribution, you can do a few hospitals to authorize a few hospitals to do)
The local bidding office has a certain understanding, and then bidding as a public relations role to help manufacturers win the bid.
Recognition of the manufacturer's products, prices, values
As for the contract, the manufacturer has a fixed template, it is only the price, the agent's province, city and volume of certain modifications, the other will not have any change, (This answer is extracted from the scientific and educational classification of the people Fang Yunge's recommendations)
The verification method of the medical device products is?If it's in a lab it's probably instrumentation devices simulating the environment.
If it comes to the end, it must be clinical trials with animals and humans.
Auqida Medical Device Consulting Organization
How do you do clinical trials for medical devices?Medical device clinical trials (validation) in its scope, complexity should be no less than the drug clinical trials, because the medical device covers far more product categories than drugs, the more common on the therapeutic class, support class, alternative and diagnostic, testing and analysis, etc., the different categories of products and their clinical trials and validation requirements are obviously not the same. Generally speaking, if there is an ISO or CE standard for a medical device, the standard will include the requirements for clinical trials; therefore, you can refer to the ISO or CE standard when conducting clinical trials. Domestic regulations are mainly considered in Decree 16 and Decree 5, technical specifications are not similar to the "Guiding Principles for Clinical Research of New Drugs" literature, are to look at specific products, with reference to similar listed species of clinical literature to consider, of course, need to be determined together with the researcher. Personal advice is to consider the clinical program from the point of view of registered product standards, registered product standards in the technical requirements, can be verified in the clinic, it is best to have clinical information; the rest of the other important aspect is the safety evaluation, the principles should be more uniform, statistical analysis of the incidence of adverse events can be illustrated by most of the problems. In terms of the current domestic medical device registration and clinical requirements, CROs are not the first choice, but they can figure out how to find the right units and experts to cope with the registration review, which should not be too difficult.
Looking for domestic hospitals by the clinical qualification, by the hospital to complete, the enterprise needs to provide the appropriate test samples, sign a contract, etc.
How to represent the medical device products?Find Device is a medical device B2B purchasing and wholesaling online shopping mall prepared and operated by Beden Medical Co!
Through the Internet, we can quickly aggregate more than 2,000 high-quality merchants, tens of thousands of medical equipment dealers and hospital resources.
TOPMEN Joint Notification Body SNCH provides comprehensive medical device product certification services for domestic enterprises to meet the EU CE requirements, while we will make full use of our international platform to provide more comprehensive services for medical device enterprises. We use different certification modes to provide certification services for manufacturers of different medical device products, services include:
1.Product classification determination
2.Enterprise technical file assistance
3.Enterprise management assistance
4.Product testing
5.Factory audit (where applicable)
6.CE Certificate Issuance
Background
1. UK-based global multinational corporation; with offices in 56 countries around the world and more than 30,000 registered customers of all types;
2. Asia-Pacific headquartered in Shanghai, providing customers with fast, professional, and trustworthy services;
3. Technical experts have been involved in the research and development of European regulations for a long time, and have decades of experience in product and system certification. Our technical experts have been involved in the research and development of European regulations for a long time, and have decades of experience in product and system certification, providing customers with one-stop solutions;
4. The certified products cover a wide range of different categories of medical devices, and the number of certified customers is more than 300;
5. The open and fair process of the certification service ensures that customers can monitor the whole process. Testing and auditingWe have localized our testing and auditing, i.e., all testing and auditing will be conducted in China by domestic staff, which can save the cost and testing cycle of enterprises.
Auzeda Medical Devices Consulting Organization