Incident Report

About Incident Reporting

CGBio is responsible for collecting reports about incidents relating to medical devices.

To perform medical device vigilance, we collect and process information that identifies or makes identifiable (“personal data”) a consumer or other reporting person by providing us with knowledge of incidents.

We will process your personal data according to our Privacy Policy compliant with the GDPR (General Data Protection Regulation(2016/679)).

(Please check the Privacy Policy in CGBio Inc below.)

Privacy Policy

INTRODUCTION

CGBio Inc. cares about your privacy and wants you to be familiar with how we collect, use, and disclose information. This Privacy Policy describes our practices in connection with information that we or our service providers collect through the website or application (hereinafter the “Service”) operated and controlled by us from which you are accessing this Privacy Policy. By providing personal information to us or by using the Service, you acknowledge that you have read and understand this Privacy Policy.

PRIVACY STATEMENT FOR CHILDREN

CGBio will not collect personal information from anyone we know to be under the age of 16 without the prior, verifiable consent from his or her legal representative. Such legal representative has the right, upon request, to view the information provided by the child and/or to require that it be deleted. If your child has submitted Personal Information and you would like to request that such Personal Information be removed, please contact us as explained below under Contacting Us.

INFORMATION COLLECTION

PERSONAL INFORMATION

Personal information collected may include:

  • Contact information, such as name, address, email, telephone number, fax number, organisation name, and/or job title;
  • Unique identifiers and preference information such as username, password, marketing preferences, internet protocol (IP) address, browser type, operating system, computer or mobile device, or navigation and clickstream behaviour for online interactions;
  • Pictures, video and audio recordings where you have provided your permission;
  • Sensitive personal information, such as health information or reports of an individual end-customer (e.g.,concerning product claims and investigations, patient pre- and post-operative outcomes for research & statistical purposes, or criminal records for due diligence procedures in accordance with applicable law).

CGBio may ask you to provide personal information for purposes including, but not limited to, the following:

  • Receiving information about CGBio products and services;
  • Storing your preferences for future interactions and communications from CGBio;
  • Helping us to develop products and services and create campaigns that are designed around you, optimise customer services and continuously improve our websites;
  • Helping us to improve products and services, and allowing CGBio to keep you informed of, or involve you in the testing of, new products and services;
  • Resolving consumer and/or product and services issues;
  • Receiving personalised messages, special offers and advertisements that are relevant to your personal interests, based on the information you have shared with us and on the information we have collected through similar techniques regarding your use of the CGBio websites/social media/blogs.

CGbio also has legal grounds to use your personal information:

  • as necessary to protect someone's health, safety or welfare; and
  • in order to comply with a law or regulation, court order or other legal process

Where required by law, we will ask you to "opt-in" or affirmatively consent to the processing of your personal data for a particular purpose. For example, where the law so requires, we will only send you newsletters if you have subscribed to them.

SENSITIVE INFORMATION

Some types of personal information are sensitive information. Sensitive information is personal information revealing or relating to your health (such as your device serial number, or the date of an implant), genetic or biometric data, your racial or ethnic origin, religious or philosophical beliefs, sex life or sexual orientation, political opinions or trade union membership.

CGBio will only collect and process your sensitive information:

  • in ways for which you have given your explicit consent
  • to protect the vital interests of you or another person, in cases where your explicit consent cannot be given or reasonably requested
  • according to applicable laws which include suitable and specific measures to safeguard your fundamental rights and interests
  • where the processing is necessary for medical purposes and we are, under the circumstances, under a duty of confidentiality equivalent to the duty of confidentiality of a health professional
  • to establish, exercise, or defend a legal claim

USE AND DISCLOSURE OF INFORMATION

Where required by applicable law, we will obtain your consent to our use of your personal information at the point of information collection. We may also use information from or about you as necessary to perform a contract, to comply with a legal obligation (for example, due to our medical device vigilance obligations), or for our legitimate business interests. We may also rely on other legal bases, specifically for:

  • Providing the functionality of the Service and fulfilling your requests.
  • Accomplishing our business purposes.

CGBio Inc. is the party responsible for the management of the jointly used Personal Information; to our third party partners with whom we offer a cobranded or comarketed promotion; to our third party service providers who provide services such as website hosting and moderating, mobile application hosting, data analysis, payment processing, order fulfillment, infrastructure provision, IT services, customer service, email and direct mail delivery services, auditing, and other services, in order to enable them to provide services; and as permitted by applicable law, to a third party in the event of any reorganization, merger, sale, joint venture, assignment, transfer, or other disposition of all or any portion of our business, assets, or stock (including in connection with any bankruptcy or similar proceedings).

In addition, we may use and disclose your information as we believe to be necessary or appropriate: (a) to comply with legal process or applicable law, which may include laws outside your country of residence; (b) as permitted by applicable law to respond to requests from public and government authorities, which may include authorities outside your country of residence; (c) to enforce our terms and conditions; and (d) to protect our rights, privacy, safety, or property, and/or that of our affiliates, you, or others. We may also use and disclose your information in other ways, after obtaining your consent to do so.

In addition, where allowed by applicable law, we may use and disclose information that is not in personally identifiable form for any purpose. If we combine information that is not in personally identifiable form with information that is identifiable (such as combining your name with your geographical location), we will treat the combined information as personal information as long as it is combined.

RIGHTS

You may request details on the personal information that we hold about you. If you believe that any personal information that we are holding about you is incorrect or incomplete, please contact us as soon as possible, at the address below. We will promptly correct any personal information found to be incorrect.

You may always choose to object to the collection or use of your personal information or to have your information erased. If you would like a copy of the information held about you for your own use or to transfer to another party or if you wish to exercise any other right, please contact us in accordance with the “Contacting Us” section below.

CROSS-BORDER TRANSFER

To the extent personal information is transferred out of the country where the owner of that personal information lives, such as to CGBio affiliates or business partners in other countries, including in the United States, different standards may apply to how your data is used and protected in those countries. CGBio has appropriate safeguards in place in accordance with applicable legal requirements to ensure that data is adequately protected irrespective of the country. This includes obtaining written assurances from any third party given access to your data so as to require them to adopt standards that ensure an equivalent level of protection for data as that adopted by CGBio and standardized corporate safeguards and contractual measures (based on the European Commission Model Clauses) for internal data transfers to CGBio affiliates in third countries which are deemed to provide an inadequate level of data protection.

SECURITY

We seek to use reasonable organizational, technical, and administrative measures designed to protect personal information under our control. Unfortunately, no data transmission over the Internet or data storage system can be guaranteed to be 100% secure. So we encourage you to therefore take special care in deciding what information you send or request via email, and take appropriate precautions such as keeping any usernames and passwords you use confidential. If you have reason to believe that your interaction with us is no longer secure (for example, if you feel that the security of any account you have with us has been compromised), please immediately notify us in accordance with the “Contacting Us” section below.

RETENTION OF INFORMATION

CGBio will retain your personal information for as long as reasonably necessary to comply with legal obligations or for no longer as required for legitimate business purposes.

THIRD PARTY SITES AND SERVICES

This website may contain links to other websites. Some of those websites may be operated by CGBio affiliates, and some may be operated by third parties. This Privacy Statement does not apply to other websites, even other CGBio websites. Therefore, whenever you leave this website we recommend that you review the privacy practices that apply to information you provide on other websites. We provide the links for your convenience, but we do not review, control, or monitor the privacy practices of websites operated by others. Neither are we are responsible for websites operated by third parties or your business dealings with them.

CONTACTING US

If you have any questions, concerns or comments about this Statement, please contact us. CGBio will use reasonable efforts to respond to you as soon as possible.
Send mail to:
CGBio. CO., Ltd.
Attn.: Data Protection Officer
F3, 211, Itaewon-ro, Yongsan-gu, Seoul, Korea
Send email to:
globalprivacy@cgbio.co.kr
If we fail to respond to you within a reasonable period of receiving it in writing or if you are dissatisfied with the response that you receive from us, you may lodge a complaint with the data protection authorities in your home country.

UPDATES TO THIS PRIVACY POLICY

We may change this Privacy Policy. Any changes to this Privacy Policy will become effective when we post the revised Privacy Policy on the Service. Your use of the Service following these changes means that you accept the revised Privacy Policy. We recommend that you regularly review the Privacy Policy when you visit the Service. This policy was last updated July 2023.

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Information for Identity VerificationMandatory

e-mail
 @ 
  • cgbio.co.kr
  • naver.com
  • daum.net
  • gmail.com
  • nate.com

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Password

Please enter a password with a mixture of numbers, alphabets, and special characters(@,$,!,%,*,#,?,&) between 8 and 12 digits.

It will be used for identity verification when viewing your incident report.

The password is encrypted and cannot be found if lost, so please remember it.

to be updated.

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