CONTENTS
- 1. Medical Device Activator | Concept
- - Medical Device
- 2. Medical Device Act | Major Acts and Punishment
- - Copyright(c) 2014. All Rights Reserved.
- - Medical Device Display and Advertising
- - COPYRIGHT(C) 2015 SHINSEGAE. ALL RIGHTS RESERVED.
- - Company
- 3. Medical Device Act | Administrative Affairs
- - Terms and Conditions
- - Anti-aging
- 4. Medical Device Activator | How to respond
- - Notice
- - Address
- - Address
- 5. Medical Device Act | Supporting Strategies and Legal
1. Medical Device Activator | Concept
The method of medical device is to protect the health of the medical device, , sales, advertise, quality control, etc.
Medical Device
The medical device law defines a wide range of products such as machine, equipment, equipment, materials and software. News <% if (imgObj.width >= imgObj.height) { %> <% if (image rate > 5) { %> The drug, medicine, medicine, and according to the "Medicine Law" are excluded. News /i>
2. Medical Device Act | Major Acts and Punishment
The violation of the law may affect the health and safety of the people, so it is important to comply with relevant laws and regulations. News /span>
You can lead to a large legal issue, All the main body involved in the medical equipment manufacturing and distribution should pay attention to responsible management and precise procedures. News /span>
News /span>
Copyright(c) 2014. All Rights Reserved.
medical device manufacturer or import business permit, medical device certification or related reporting procedures are subject to the medical device law.
, repair, sell, lease, use, use, News /span>
this is next and like punishment will be back News /span>
Medical Device Display and Advertising
The container of the medical device, External, Package, The following information is forbidden to display or disseminate the following information.
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COPYRIGHT(C) 2015 SHINSEGAE. ALL RIGHTS RESERVED.
Representatives specified as a non-invasive test laboratory or quality control body, resulting in clinical trial results, Non-invasive test report, The quality control result is falsely written or issued.
In addition, medical equipment manufacturing and importers, etc. may be punished by the violation of the law, or not disclose the expenditure of the provision of economic benefits; News /span>
Company
Company's representative, who is, who is, who is, who is, who is, who is, who is, who is, who is, News /strong>
Only, fines are exempt if there is enough attention and supervision for the company or individuals to prevent violations. News /span>
3. Medical Device Act | Administrative Affairs
A variety of administrative materials may be imposed according to the symmetricity of the above action, this may affect the business operation, so each person needs to be careful. News /span>
Production of specific medical devices, Inclusion, Can be prohibited for sale, All of the services or some may be suspended for 1 year, The business may follow serious pharmaceutical
Terms and Conditions
Food and Drug Administration, Temperature Testing Center, Temperature Testing Center, Technical Interpreter, Quality Control Center,etc. News /strong>
This is specified in false or negative ways, or if he completes false reports with great error. News /span>
Also, Cannot receive re-registration within 3 years. News /strong>
Anti-aging
If there is a work stop disposal due to the violation of the medical device, The medical device can be replaced by an overturn disposal when there is a serious discomfort or concern to the public interest. <% if (imgObj.width >= imgObj.height) { %> 75%, 60%);">The deposit is charged up to and, is set to the deposit amount and collection method according to the type of act.
4. Medical Device Activator | How to respond
The violation of the law may lead to criminal offence, as well as the News /span>
You can follow serious constraints in business operations in accordance with this, If the above occur, you need prompt and accurate response. News /span>
Notice
When the investigation is started, it is important to actively respond to the investigation. News /span>
is essential to identify internal situations and systematically secure relevant evidence data. News /span>
All evidence must be collected in the right way, should prevent adverse interpretations carefully reviewed. News /span>
Address
If you wish to raise an objection to a disposition such as business suspension or fine for violation of the Medical Device Act, you may file an administrative appeal within 90 days from the date you received the notice of disposition.
▶ How to write an administrative appeal request
The administrative appeal request must be in writing, and the request must accurately contain the required information required by law.
• Name and address or office address of the claimant
• Respondent and Name of the Administrative Judgment Committee
• Specific details of the disposition subject to the adjudication request
• Date upon learning of the disposition
• Purpose of the adjudication request and Reason
• Whether or not the respondent notified the administrative trial and its contents
※If the claimant is a corporation or foundation without legal personality, or a selected representative or agent, the name and address of the representative, manager, selected representative or agent must be entered in addition to the above basic information.
Address
If you don't have any remedy as a trial, can raise the administration within 60 days of the remedy date News <% if (imgObj.width >= imgObj.height) { %>
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Changwon is a part of which the right or legal interest in claims by the petition.
should clearly write the facts and legal reasons that are based on the so-called claim.
5. Medical Device Act | Supporting Strategies and Legal
The medical device law enforcement is strictly punished, therefore, medical device manufacturer, importer, seller, of course, the medical device must comply with the relevant laws.
If you are involved in a medical instrumentation event, is an active and prompt response in seconds, is very important to be actively claimed to the investigation agency through a clear material which can prove the integrity. News /span>
The medical representatives of this corporation have been rich experience in various medical devices and health benefits such as medical devices CSO Related Legal Review, Related Medical Drugs & Safety Responsibilities, Related Research Plan Advisory. News /span>
True "> 61%, 41% );">medical expert counselorand to help to help strategy to help.
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