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Get Instant Medical Device Registration by FDA Listing Inc.

FDA Listing Inc. is top FDA US agent, who will help in the FDA device registration process and compliance with FDA rules. We are available 24 hours a day to answer your questions via our Online Live Help. Contact us today!

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China is one of the fastest growing markets for Medical Devices where the demand for devices is majorly met through exports.

National Medical Products Administration (NMPA) (formerly CFDA) and Centre for Medical Device Evaluation (CMDE) is responsible for the review of the medical device import registration applications of all 3 classes of devices (Class I, II & III).

Class II and III devices require clinical data from NMPA accredited labs whose approval can take up to 2 years.

While aiming at Chinese market entry, applicants should ensure that the key documents are duly attached to get approvals within the review timelines.

Some of the documents and review timelines include:

Freyr supports client to obtain various certifications and to compile other documentation that leads to market approval within strict timelines.

Get complete document list for China Get Timelines for approval in China

Freyr supports client to obtain various certifications and to compile other documentation that leads to market approval within strict timelines. With clear-cut knowledge on local Regulatory landscape, Freyr guides manufacturers in successful clinical testing and the study data compilation as regulated by the NMPA. 

Freyr Expertise

Premarket Registration Support

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    • Technical Document Preparation and Gap Analysis

    • Safety, Quality and Efficacy Assessment

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    • Self-assurance Statement Preparation

    • IFU and Draft Label Preparation and Translation

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    • Local Agent Support, Attend Review Meetings

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Summary

S. No

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China

1

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CFDA

2

Regulation

State Council Order No.650

3

Risk Classification

Class I

Class II

Class III

4

Regulatory Pathway

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Notification

Class II & III

Registration

5

Authorized Representative

China Agent required

6

Fee payable

Class I

No Fee

Class II

~ $34,000*

Class III

~ $ 48,000*

7

QMS Requirement

YY/T0287-2017

ISO 13485

8

Assessment of Technical Data

Center for Medical Device Evaluation (CMDE)

9

Validity of License

Class I

Unlimited

 

 

Class II & III

5 Years

10

Labelling Requirements

Decree No.6 of CFDA

11

Submission format

Paper

12

Final Outcome

Class I

Notification

 

 

Class II & III

Registration Certificate

13

Timelines

Class I

3 -6 months

 

 

Class II

1 - 2 years

 

 

Class III

More than 2 years

14

Language

English & Chinese

*The price is as per records at the time of documentation and is subject to change.

Process Flow

Canada Medical Device Regulations

To know more about NMPA’s drug regulations and the local Regulatory assistance, reach out to us at [email protected]

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Unlocking FDA Compliance: The Role of FDA Lawyers, Labels, and Attorneys
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Navigating the complex landscape of FDA regulations requires expert knowledge, and FDA lawyers, FDA labels, and FDA attorney are indispensable in this process. The Role of FDA LawyersFDA lawyers are legal professionals specializing in FDA regulations and compliance. Labeling Compliance: FDA regulations mandate that product labels provide accurate and truthful information to consumers. While similar to FDA lawyers, FDA attorneys may have broader legal expertise beyond FDA regulations, including administrative law, litigation, and corporate governance. Key responsibilities of FDA attorneys include:Legal Representation: FDA attorneys represent clients in administrative proceedings, negotiations with the FDA, and litigation involving FDA regulations.
Compliance to FDA 21 CFR Part 11 Requirements
jack 2021-05-11
img

This whitepaper documents ComplianceQuest’s position regarding compliance to Electronic Records; Electronic Signatures 21 CFR Part 11.

Some industrial segments need to be exponentially stringent with their quality and compliance processes compared to other segments.

The Life Science industry is part of this stringent segment.

They need to ensure the quality of their products because they deal with human safety.

The accuracy and efficiency of their work could well be a matter of life and death.

The FDA 510k Submission Process: What You Need to Know
Maven 2023-02-24
img
 Stages of FDA 510k process 1. The FDA 510k submission process can be complex and time consuming, so it is important to work with an experienced regulatory consultant to ensure that the submission is complete and accurate. The first step in the FDA 510k submission process is to create a device description. The FDA 510k submission process is an important step for any medical device manufacturer who wishes to sell their device in the United States. One-stop Solution for US FDA 510kMaven is one of the best regulatory consultants for the US FDA 510k services of your product.
How Is AI Optimizing Different Aspects of FDA Submissions?
Ingenious E-Brain Solutions 2023-04-28
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Nowadays, companies are leveraging artificial intelligence for effective and quick submissions. · Traditionally, the FDA evaluates medical devices through a suitable premarket pathway, such as De Novo classification or premarket approval. The FDA’s traditional medical device regulation paradigm was not intended for adaptive artificial intelligence and machine learning technologies. Under the FDA’s current approach to software changes, the FDA anticipates that many artificial intelligence and machine learning-driven software modifications to a device need a premarket review. ” This explains the FDA’s foundation for a possible way to premarket review for artificial intelligence and machine learning-driven software modifications.
Israel Joffe
israeljoffefda 2022-02-01
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I am  Israel Joffe FDA For nearly 20 years, I have been developing my skills and experiences at major organizations such as Starwood Hotels, Fox 5 News, ABC News, Fox News and the Food and Drug Administration. In that time, I have worked in various roles that have given me a vast array of experiences in project management, IT development, infrastructure procurement, requirements gathering, writing and editing news, videos, websites, developing social media strategies and more.
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Depending on the findings of the examination, the FDA may issue a Notice of Action. In this blog, we will discuss what an FDA Notice of Action is and how an experienced attorney like CustomsESQ/Abady Law Firm P. What is an FDA Notice of Action? The FDA district office then issues a “Notice of FDA Action. For more information about an FDA notice of action or for assistance with any of the issues noted above, contact Abady Law Firm, P.
Separating Fact from Fiction: Unveiling the Truth about Confidence USA
laurain784 2023-06-02
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Introduction:In a recent article published by NutraIngredients USA, claims have been made regarding Confidence USA's alleged closure due to a decade of inspection failures. Committed to Quality and Compliance:Confidence USA has consistently demonstrated its commitment to quality and compliance. It has garnered a loyal customer base that values the company's transparency and commitment to delivering products that meet stringent quality standards. Numerous positive customer testimonials and reviews attest to the effectiveness and trustworthiness of Confidence USA's offerings. It has garnered a loyal customer base that values the company's transparency and commitment to delivering products that meet stringent quality standards. Numerous positive customer testimonials and reviews attest to the effectiveness and trustworthiness of Confidence USA's offerings. FDA Registration and Compliance:Contrary to the claims made in the article, Confidence USA maintains FDA registration, which demonstrates its compliance with regulatory requirements.
Strategic Regulatory Partner for Success in Thailand
Freyr Thailand 2024-02-22
img
Greetings from Freyr ThailandFreyr is a global Regulatory leader providing services and solutions to Life Sciences companies in their entire Regulatory value chain. With our presence in 120+ countries, we help Life Sciences companies in their “local to global” journey. At Freyr Thailand, we support companies to register their products with the Thai FDA, Regulatory strategy, market intelligence, in-country representation, PMS functions, and more. We also offer next-gen Regulatory software solutions covering the complete Thai FDA registration life cycle. With updated Regulatory intelligence over the new Regulatory system of Thailand, Freyr assists new market entrants to keep pace with the evolved Regulatory requirements related to registrations, dossier compilation, and submissions for the necessary market authorizations.
Information about FDA 510k Approval for US
Jassy Sam 2022-09-23
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What Does a FDA 510( k) Clearance mean? When a medical device is cleared, this means it has experienced a 510( k) submission, which FDA has reviewed and handed clearance. For Class III medical devices to be legally marketed they must suffer a rigorous review and approval process orpre-market approval( PMA). Our team of good experts will successfully prepare and submit FDA medical device regulatory documents for theU. Technically, under the 510( k) process, the FDA doesn't “ authorize ” medical devices and IVDs; the FDA issues a “ clearance ” or “ Approval ” for deal in the United States.
Introduction to FDA Lawyer
mghcmku 2024-03-14
img
An FDA lawyer is a legal professional specializing in matters related to the Food and Drug Administration (FDA). Roles and Responsibilities of an FDA LawyerUnderstanding FDA RegulationsFDA lawyers must have a comprehensive understanding of the regulations set forth by the FDA. Knowledge of FDA RegulationsIn addition to legal expertise, FDA lawyers must possess a deep understanding of FDA regulations and policies. How to Find a Competent FDA LawyerResearch and ReferralsWhen seeking an FDA lawyer, it's essential to conduct thorough research and seek referrals from trusted sources. How can an FDA lawyer help with FDA inspections and audits?
EU MDR Advisory Services|EUMDR
david bhagya 2020-09-11
img

Since decades, regulation of the medical device industry in Europe has been rather unchanged.

However, recent events have now prompted for vital regulatory & compliance reforms to the medical devices industry.

The new Medical Device Regulation adopted by EU, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive.for more info visit: https://www.makrocare.com/devhttps://www.makrocare.com/devices/medical-device-regulationices/medical-device-regulation

Why Do Businesses Need Computerized System Validation
WCS Consulting Inc. 2021-07-13
img

One should not overlook this step as the consequences are not going to be so good.

Ignoring or avoiding computerized system validation can result in a great compromise to the integrity, putting the clients of the company on the line, datum corruption, and whatnot.Who Needs Computer Validation Services?Now that we have made it clear what computer validation is, let’s take a look at who all require it.

Before that, let’s make one thing clear, computer validation is so much more than reducing several risks related to business.For example, detecting the defects in medication will avoid serious problems such as unfortunate side-effects or any major problem that a customer or consumer could come across.

Thus, computer system validation is an immensely important stage for certain organizations.With that being said, let's have a look at some of the businesses, which are enforced legally for conducting CSV.Storage and Distribution Providers – It is vital for the businesses that store medications, cell and tissue products, biological, etc., to incorporate a computer validation system.

In case such companies fail to compete with the CSV, there will be strict penalties, which might be as severe as debarment or criminal prosecution.Medical Device Distributors – It is also obligatory for the business that stores medical devices to use a computer validation system.

What exactly are the medical device distributors?

Medical Device Regulatory Services in China
freyr solutions 2018-12-06
img

China is one of the fastest growing markets for Medical Devices where the demand for devices is majorly met through exports.

National Medical Products Administration (NMPA) (formerly CFDA) and Centre for Medical Device Evaluation (CMDE) is responsible for the review of the medical device import registration applications of all 3 classes of devices (Class I, II & III).

Class II and III devices require clinical data from NMPA accredited labs whose approval can take up to 2 years.

While aiming at Chinese market entry, applicants should ensure that the key documents are duly attached to get approvals within the review timelines.

Some of the documents and review timelines include:

Freyr supports client to obtain various certifications and to compile other documentation that leads to market approval within strict timelines.

Get complete document list for China Get Timelines for approval in China

Freyr supports client to obtain various certifications and to compile other documentation that leads to market approval within strict timelines. With clear-cut knowledge on local Regulatory landscape, Freyr guides manufacturers in successful clinical testing and the study data compilation as regulated by the NMPA. 

Freyr Expertise

Premarket Registration Support

  • Regulatory Strategy

    • Device Classification as per NMPA

    • Assess Clinical Trial Requirements and Exemptions or CER

    • In case of CER, Evaluation of Technical Clinical Information of a Predictive/Prototype CFDA Approved Device or Review of Existing Clinical Trial Tata Standards

    • Technical Document Preparation and Gap Analysis

    • Safety, Quality and Efficacy Assessment

  • Regulatory Submission and Approval

    • Compilation of Technical Documents and Registration Application

    • Dossier Translation

    • Clinical Testing Support and Management

    • Risk assessment, QMS Audit and Compliance

    • Self-assurance Statement Preparation

    • IFU and Draft Label Preparation and Translation

    • Labeling and Artwork Compliance

    • Local Agent Support, Attend Review Meetings

    • Liaison with HA until Approval

    • Import Permit and Custom Support

Clinical Trial Support and Management

  • Quality Maintenance

    • NMPA Audit Preparation

    • QMS Implementation and Monitoring Compliance

    • Standard Operating Procedure (SOP) Writing and Implementation

    • Quality Manual Writing

    • Ethics Standard Implementation and Monitoring

    • Ethical Review of Clinical Protocol

    • GxP Compliance

  • Clinical Trial Support

    • CRO Oversight and Management

    • Clinical Trial Application (CTA)

    • Pre-clinical Investigation of Medical Devices

    • Clinical Trial Protocol Design and Writing

    • Clinical Trial Auditing and Quality Assurance

    • Data Management and Statistical Analysis

    • Clinical Studies Report Writing

Post-Approval Regulatory Support

  • Post-Market Compliance

    • Monitoring and Reporting Adverse Events

    • Product Recall

    • HA Query Responses to Regulatory and Audits

    • Quality Management System (GMP and GSP compliance)

    • Review of Extrapolating Studies

    • Advertisement and Promotional Material Regulatory Compliance and Approval

    • License Renewals and Updates- Technical Document Review and Filing

Summary

S. No

Regulatory Parameter

China

1

Regulatory Authority

CFDA

2

Regulation

State Council Order No.650

3

Risk Classification

Class I

Class II

Class III

4

Regulatory Pathway

Class I

Notification

Class II & III

Registration

5

Authorized Representative

China Agent required

6

Fee payable

Class I

No Fee

Class II

~ $34,000*

Class III

~ $ 48,000*

7

QMS Requirement

YY/T0287-2017

ISO 13485

8

Assessment of Technical Data

Center for Medical Device Evaluation (CMDE)

9

Validity of License

Class I

Unlimited

 

 

Class II & III

5 Years

10

Labelling Requirements

Decree No.6 of CFDA

11

Submission format

Paper

12

Final Outcome

Class I

Notification

 

 

Class II & III

Registration Certificate

13

Timelines

Class I

3 -6 months

 

 

Class II

1 - 2 years

 

 

Class III

More than 2 years

14

Language

English & Chinese

*The price is as per records at the time of documentation and is subject to change.

Process Flow

Canada Medical Device Regulations

To know more about NMPA’s drug regulations and the local Regulatory assistance, reach out to us at [email protected]

What functionalities are offered in the BSE platform of this mutual fund software for IFA ?
Red Vision 2019-11-08
img

The functionalities such as BSE registration, Mandate registration, Client registration, FATCA registration, invest online platform, and transaction log maintenance, etc are provided in this mutual fund software for IFA .

We have enabled all this inside the BSE platform integrated within our system.

For more information visit @- https://www.redvisiontech.com/