Any commercial organization needs progress - in respect of its business activities, profitability and growth vertically and horizontally. For achieving this overall progress, the vital aspect needed is Customer Confidence.
If every customer associated with the organization as consumer is satisfied with its processes, functionalities, products, quality assurance systems and procedures, and places their trust with the organization fully, all the above factors of progress becomes automatic. More number of customers brings forth more sales, volume of business, profitability and thereby continued prosperity. QMS Audit
Well - the million-dollar question is how to build Customer Confidence? The organization in question cannot contact each and every customer, and explain them their process capabilities; stages of production; how they ensure complete quality assurance in each stage; and how they ensure best quality products at affordable prices are delivered to the customer etc.
In the same way, not every customer can visit the organization and see for themselves, whether all the above parameters are adhered impeccably, to achieve total quality assurance. Here comes the help of ISO Certification, official certification by International Standards Organization - that can be obtained through the assistance of ISO Certification Services. Let us explain this point taking an example of an Australian Industrial Manufacturing Organization. ISO 9001 Accreditation
ISO Accreditation:
This organization is manufacturing and supplying all over the world high quality Australian Oats. As of today, the world consumers are very well aware of the characteristics of "Consumerism" - that is "buying best quality products at lowest prices" - thanks to the Internet.
In addition to product quality, the manufacturers have to abide by the Legislations enacted by the Law of the Land, in ensuring that by their production processes there is no damaging impact on environment - air; noise; water or other types of pollution. The ultimate consumer is also keen that the product coming to them is "environment-friendly". ISO 9001 Australia
As such, in order to carry on their business in Australian soil and also convince their end-users of the product, Your Company has to obtain ISO Accreditation. This certification they cannot get, unless and until they satisfy the stipulations imposed by ISO Certification authorities and they are completely and comprehensively fulfilled in each and every stage of manufacture; and also preventing the ill-effects of environmental pollution.
How to get this ISO Certification?
Your Company should contact an ISO Consultant in Australia. This is the authority that offers ISO Certification Services, to get Your Company accredited with ISO and obtain ISO 9001 Certification. There are many ISO Consultant experts in this authority, who are thorough with the procedures and formalities attached to ISO Accreditation. Quality Assurance Consultant
They will not only help implement international standards and effective systems of controlling environmental impacts, but also educate all the employees of Your Company, everything from elementary lessons of ISO Certification. They will do whatever is needed to get Your Company the world-recognized ISO 9001 Certification; and even after certification, for the perpetual maintenance of the systems and procedures.
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
To know more about NMPA’s drug regulations and the local Regulatory assistance, reach out to us at [email protected]
The QMS enables this by centralizing the quality management system, thereby providing an organization-wide view of data, information and processes.
A QMS ensures consistent quality of products and processes, mid-course corrections, root cause analysis in case of any problems and deviations, audit management, supplier customer relationship management, complaints handling as well as continuous improvement.
