In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
Japan PMDA Medical Device Regulatory Approval ProcessEMERGO
Watch the recorded webinar: https://www.emergogroup.com/resources/video-webinar-japan-registration-process
Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, will discuss some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
Plus more ...
This presentation is an overview of the Medical Device Regulatory Process for China. I used this to teach about SFDA Order No. 27, the amendments, Order No. 15 (Classification), Order No. 16 (Registration), YY, GB, YY/T, GB/T, YZB standards and the different registration forms to use for devices made in People\'s Republic of China, about imported medical devices, and about devices allowed from Taiwan, Hong Kong and Macau regions.
Japan PMDA Medical Device Regulatory Approval ProcessEMERGO
Watch the recorded webinar: https://www.emergogroup.com/resources/video-webinar-japan-registration-process
Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, will discuss some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
Plus more ...
INDIA MEDICAL DEVICE REGULATORY LANDSCAPEInsights10
The Indian medical device regulatory landscape is constantly evolving. In recent years, the government has implemented several new regulations to improve the safety and quality of medical devices. This has created new challenges and opportunities for medical device manufacturers and importers. To get a detailed report, contact us at - info@insights10.com, visit - https://bit.ly/3T4fMvE
Medical device management in china and latest regulatory updates_EdwinCIRS China
Currently, China is one of the world's most promising markets for medical devices, which on the back of its vast market size, offers huge potential to medical device companies. All medical devices marketed or sold for use in China must be registered with China Food and Drug Administration (CFDA).
S.R.O.32(I)/2018.— In exercise of the powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012), the Drug Regulatory Authority of Pakistan, with the approval of the Federal Government, is pleased to make the following rules, namely
Nowadays, health is given much priority in all aspects. The present
generation is very much conscious about having periodic checkups
and maintaining a good health. This awareness has given an upper
hand to the medical equipment business. The healthcare industry is
booming like no other field and because of this, Medical Device
Regulation India has also become equally complicated. Unlike
previous years, nowadays most medical devices are required to be
registered and need approval for business
NEST – Improving the Regulatory Process for Medical DevicesEMMAIntl
Innovating the medical device regulatory process is a goal that the FDA’s Center for Devices and Radiological Health (CDRH) is constantly striving towards. Among several other programs introduced or changed over the past couple years, the National Evaluation System for Health Technology (NEST) is a program the FDA is building upon to generate better real-world evidence to guide their decision-making around medical devices...
As you start to map out your global strategy beyond the US, Canada and Europe, there are six key steps to follow and multiple regulations to consider. Harmonization has increased in recent years, yet most countries still maintain distinct medical device regulatory systems. Careful analysis on a market-by-market basis will help you to fully realize compliance requirements affecting a particular market. Explore these six steps as we reveal insights into the unique medical device regulations affecting markets in Russia, Brazil, Japan, China, and India.
Strategies for Device Approval in China, India, South Korea and AustraliaApril Bright
This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
A Step-By-Step Guide To CDSCO _Medical Device Registration.pdfPranshuCorpseed
In the complex world of healthcare, where people's lives are on the line, maintaining the quality, safety, and efficacy of medical devices is a non-negotiable need. The Central Drugs Standard Control Organization (CDSCO) is a vigilant monitor in India's vibrant healthcare business. The crucial role of CDSCO is around the rigorous registration and regulation of medical devices, and its impact is felt throughout the entire healthcare ecosystem.
New Medical Device Regulation Implications For Medical Device ManufacturersPEPGRA Healthcare
Pepgra offers regulatory consulting for Medical device and IVD companies. We help you in Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations.
Learn more: https://www.pepgra.com/device-manufacturers/
Need Help:
Uk: +44- 7424810299
Email: sales@pepgra.com
Whatsapp: +91 9884350006
overview of Anvisa Requirements, Medical device classification and grouping, cadostro registration pathway,resgistro pathway,INMETRO Certification, Summary of Anvisa Registration Process
Similar to Overview and update of chinese medical device regulation (20)
This presentation by Morris Kleiner (University of Minnesota), was made during the discussion “Competition and Regulation in Professions and Occupations” held at the Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found out at oe.cd/crps.
This presentation was uploaded with the author’s consent.
Sharpen existing tools or get a new toolbox? Contemporary cluster initiatives...Orkestra
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Have you ever wondered how search works while visiting an e-commerce site, internal website, or searching through other types of online resources? Look no further than this informative session on the ways that taxonomies help end-users navigate the internet! Hear from taxonomists and other information professionals who have first-hand experience creating and working with taxonomies that aid in navigation, search, and discovery across a range of disciplines.
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2. CONTENTS
Overview of China’s Medical Device Management
The Latest Update of China’s Medical Device Regulation
Implementation Progress of UDI in China
Overview of China’s Medical Device Registration Electronic Declaration
Information System (eRPS)
Amendments of Medical Device Supervision and Administration
Regulations
Brief Analysis of MAH System of Medical Device Industry in China
Practical Advice on How to Register a Medical Device in China
4. www.cirs-group.com
Chinese Medical Device Market
In 2018, China's health expenditure was $777 billion and accounted for 5.7% of China’s GDP,
which is a far lower percentage than countries like the U.S. (17%), Germany (11%), Canada
(10%), and Japan (10%). Health expenditure, as a percentage of GDP, is expected to increase
to between 6.5-7% by 2020.
Globally, the medical device market is approximately 42% of the size of the pharmaceuticals
market. In China, however, the percentage is much lower at approximately 14%.
6. www.cirs-group.com
constit
ution
Legislatio
n
Administrative l
aws and regulat
ions
Regulations
Regulated documents
Local regulations and standards
Administrative Permission Law,
Standardization law, Pharmaceutical
Administration Law, etc.
Medical Device Supervision and
Management Regulations
Medical Device Registration
Management Measures, Medical Device
Production Supervision and
Management Measures
Innovative Medical Device Special
Approval Procedures, registration review
guidelines, etc.
Classification Determination
notices, NMPA Announcements,
Industry Standards, etc.
China's Medical Device Regulatory System
7. www.cirs-group.com
Classification Management System
Classification Class I Class II Class III
Registration
Procedure
Put on record/ Filing Registration Registration
Production
Procedure
Put on record/ Filing Production Permit Production Permit
Business Procedure N/A Put on record/ Filing Business Permit
The Class I is the medical device that is low-risk and requires routine management to
ensure its safety and effectiveness.
The Class II is the medical device that is moderate-risk and requires strict control and
management to ensure their safety and effectiveness.
The Class III is the medical device that is high-risk and require special measures to
strictly control management to ensure their safety and effectiveness.
To evaluate the degree of risk of medical devices, factors such as the intended purpose,
structural characteristics, and methods of use of medical devices should be considered.
8. www.cirs-group.com
Registration Process
Is this a
medical device
product?
No
Yes
Other requirements
Apply for product
classification
determination
Registration Testing
Submit materials;
Administrative
review
Technical review,
Administrative
review
Clinical trials
Prepare required
materials
Able to
determine the
product category?
Registration
certificate
Supplement
missing materials
Supplement missing
materials ,resubmit
the application
QMS audit
Recording
certificate
Are the
materials
complete?
Is the product
exempted for
the clinical trials?
No
Yes
Yes
No
Yes
No
Do you have
agent in China?
No Find a Chinese
agentYes
Class I Class II, III
10. www.cirs-group.com
The Ministry of Justice issued the "Amendments of Medical Device
Supervision and Administration Regulations (Draft for Review)“
Notice of the NMPA on the Revised Project Plan for the 2019 Medical
Device Industry Standard
Notice on Application for Collection of Digital Certificate (CA) for
Medical Device Registration Electronic Declaration Information System
the NMPA issued the "Notice on Expanding the Pilot Work of Medical
Device MAH System" ([2019] No. 33)
"Medical Device Unique Identification System Rules" officially released;
Interpretation of "Medical Device Unique Identification System Rules"
Notice of the NMPA on issuing specifications for medical device
inspection
Notice on the Submission of Electronic Registration of Medical Device
Registration and Prohibition of Repeated Submission (No. 15 of 2019)
2018.06.25
2019.03.20
2019.05.07
2019.08.01
2019.08.27
2019.09.05
2019.10.14
12. www.cirs-group.com
Unique Device Identification (UDI)
Unique Device Identification (UDI) refers to a code consisting of
numbers, letters, or symbols attached to a medical device product
or package, and is used to uniquely identify a medical device.
Unique medical device identification includes: Device Identification
(DI) and Production Identification (PI).
14. www.cirs-group.com
Declaration Process of DI
Choose a code issuing
agency
The medical device registrant / filer chooses a qualified
code issuing agency.
Start coding
The code issuing agency provides the code segment
and corresponding coding rules to the registrant / filer ,
and guides the coding work.
Registration
declaration
Newly registered products need to report DI in the
registration system.
Encode the devices The registrant / filer assigns a code to the product,
giving it a unique identification.
Identification
declaration
After the product code is completed, log in to the
NMPA ’s medical devices UDI management information
system and carry out work related to the UDI
declaration of the product.
15. www.cirs-group.com
Pilot Schedule of UDI
Time Plan
2019.07
Identify pilot varieties and participating units. Establish a collaborative working
group for the pilot work department of the UDI and issue a pilot work plan.
Organize pilot training and start pilot work. The pilot unit shall formulate
implementation plans, refine the task measures, and clarify the acceptance
indicators.
2019.08—11
Organize the verification work of creation and assignment of UDI for medical
devices.
2019.12—2020.02
Organize the verification work of upload, download and interface standards
for medical device’s UDI databases
2020.03—06
Organize the verification work of Inter-departmental connectivity and
extension applications of UDI data
2020.07
Organize a pilot summary meeting to form a pilot report and improve the UDI
implementation plan for the first batch of products.
16. www.cirs-group.com
The Completed Pilot Work
Time Completed work
2019-07-03 Issued a pilot work plan and started pilot work.
2019-08-09 Organized pilot training and Identified participating units.
2019-08-27
Established a collaborative working group for the pilot work
department of the UDI.
2019-10-15 Identified pilot varieties
18. www.cirs-group.com
eRPS System
The eRPS system displays the current medical device registration application
requirements in China in the form of a directory listing (ToC) of the International
Medical Device Regulatory Agency Forum’s (IMDRF) Registration Declaration
Specification (RPS) project.
Key Benefits
-Convenient for registered
applicants to submit
registration documents
-Save review approval
time and standardize
registration process
-Complete and clear
catalog of required
materials
-Adopt CA(Certification
Authority) to improve data
security level
19. www.cirs-group.com
Certification Authority (CA) Certificate
The CA certificate is provided by the nationally approved electronic
certification service agency, with USB KEY as the medium, as an identity
verification certificate and electronic signature tool for applicants to log in and
upload electronic filing materials.
20. www.cirs-group.com
Scope of Application
Registration of domestic Class III medical devices / IVD reagents
Registration of imported Class II and III medical devices / IVD reagents
Continuation registration of domestic / imported medical devices / IVD
reagents
Alteration registration of domestic / imported medical devices / IVD reagents
Clinical trial approval domestic / imported medical device / IVD reagents
Special review of innovative medical devices
Notification of alterations to medical device instructions
Correction of alteration document of medical device / IVD reagent
registration certificate
Review of medical device / IVD reagents registration / license alteration
22. www.cirs-group.com
Release Time Standards and Regulations
2019-05-07
Notice on Application for Collection of Digital Certificate (CA) for Medical Device
Registration Electronic Declaration Information System
2019-05-31
Announcement on Implementing Electronic Declaration of Medical Device
Registration (No. 46 of 2019);
Notice on the Technical Guidelines for Electronic Declaration of Medical Device
Registration Applications (No. 29 of 2019)
2019-06-06
Notice on Relevant Issues Concerning the Handling of Medical Device Registration
Electronic Declaration Information System Business (No. 4 of 2019);
Notice on the Structure of the Electronic Filing Directory Folder of the Medical
Device Registration Electronic Declaration Information System (No. 5 of 2019)
2019-07-10
Notice on the Relevant Material Requirements for Electronic Declaration of Medical
Devices (No. 41 of 2019);
Notice of the "Medical Device Product Registration Project Filing Review
Requirements (Trial)" (No. 42 of 2019)
2019-10-14
Notice on the Submission of Electronic Registration of Medical Device Registration
and Prohibition of Repeated Submission (No. 15 of 2019)
23. www.cirs-group.com
Implementation Date of eRPS System
Since May 10, 2019, medical device registration applicants could apply for the Digital
Certificate (CA) for the eRPS system.
On June 24, 2019, the eRPS system was officially launched. At the same time, the
NMPA maintains the submission of paper materials.
From November 1, 2019, the submission of paper materials shall be in accordance
with the requirements of the "Technical Guide for Electronic Submission of Medical
Device Registration Applications (Trial)", which is consistent with the form of the
electronic filing catalog
26. www.cirs-group.com
Brief Introduction
On June 25th, 2018, the government website of the Ministry of Justice issued a public
consultation notice on the "Amendment of Medical Device Supervision and
Management Regulations (Draft for Review)".
27. www.cirs-group.com
There were 53 amendments in this revised draft: adding 12 articles, deleting 2
articles and modifying 39 articles. Among them, the main changes are as follows:
1. Improve the MAH system
2. Increase the regulations on the management of Chinese agents of overseas
registration certificate holders
3. Reform the clinical trial management system
4. Optimize the review and approval procedures and recover the approval
authority for the registration and review of the Class II medical device products
5. Some Class II medical equipment can be operated without filing
28. www.cirs-group.com
6. Clearly prohibit the import and sale of used medical devices
7. Cancel the approval of medical device advertisements
8. Increase the concept of counterfeit medical devices
9. Clarify the supervision and inspection of the National, the provincial and
the municipal medical products administration, and increase the regulatory
measures.
10. Improve the re-inspection system
11. Add specific provisions for penalties to people
12. Increase the penalty amount for intentional violations
31. www.cirs-group.com
MAH System
What is the Marketing Authorization Holder (MAH)?
The holder of the marketing authorization is the person who applies for the
registration the medical device, and has filed with the local Medical Product
Administration or approved by the NMPA, and obtained the medical device
registration certificate.
1. Establish a quality management system that is compatible
with the product and maintain effective operation;
2. Develop a continuous research and risk management plan
after listing and ensure its effective implementation;
3. Carry out adverse event monitoring work according to law
and re-evaluation work;
4. Establish and implement a product traceability and recall
system;
5. Other obligations as stipulated by the drug regulatory
department of the State Council.
What are the obligations of Marketing Authorization Holder?
32. www.cirs-group.com
Basic conditions for Production Company (Trustee)
1. The production address of the enterprise is located in the pilot provinces, autonomous
regions and municipalities.
2. Possess a quality management system and production capacity that are compatible with
the production of medical device entrusted.
3. Encouraged to have the YY0287 / ISO13485 certification.
MAH System
Basic conditions for Marketing Authorization Holder
1. The residence or production address of the enterprise or scientific research institution is
located in the pilot provinces, autonomous regions and municipalities.
2. Full-time technical and management personnel related to regulatory affairs, quality
management, post-marketing affairs, etc., with relevant knowledge and experience.
3.Establish a QMS that is compatible with the product and maintain effective operation, and
have staff who independently evaluate, review and supervise the QMS.
4.Ability to take responsibility for quality and safety of medical devices
33. www.cirs-group.com
Three Parties in MAH System
Client
• Screening of Entrusted
Companies
• Quality audit and quality
agreement
• R & D and production
conversion
• Annual quality review
• Production release and
market release standards
• Re-evaluation mechanism
and after-sales service
• Quality traceability system
Trustee
• Fulfilling regulatory
requirements
• GMP compliance
• Meet the agreed
content of the quality
agreement
• Production of samples
and products
• Production quality
control
• Reporting mechanism
Supervisor
• Assess the contract
and quality agreement
between the two parties
• Assess the client's
quality management
capabilities
• Assess trustee
qualifications and
capabilities
• On-site inspection and
post-market supervision
34. www.cirs-group.com
MAH SYSTEM CURRENT SYSTEM
Applicant for
Registration
Enterprises and research institutions in
the 21 pilot provinces and cities Medical device manufacturer
Product Launch
Mode
The registrant could entrust a third party
to develop, produce, sell and compliance
audit; the registrant could only hold the
medical device registration certificate;
and it is allowed to commission a number
of production enterprises to produce.
The registrant shall hold both the
medical device registration certificate
and the production license, and the
enterprise that accepts the
commissioned production shall also
hold the corresponding registration
certificate and production license.
The Relevant Party of
the Marketing
Authorization
Marketing authorization holder (the
trustor); medical device research and
development institution or production
organization (the trustee); regulator
Medical device manufacturer; regulator
Comparison
35. www.cirs-group.com
Implementation of MAH System
Release Time Standards and Regulations
2017-10-08
The State Council issued the Opinions on Deepening the Reform of the Review
and Approval System and Encouraging the Innovation of Drugs and Medical
Devices
2017-12-07
Shanghai took the lead in launching the pilot work and released the pilot
scheme of the medical device registrant system.
2018-05-24
Guangdong and Tianjin announced plans to deepen the reform of the free trade
zone, and the pilot work of the medical MAH system was extended to
Guangdong and Tianjin.
2018-06-25
The Ministry of Justice issued the "Amendments of Medical Device Supervision
and Administration Regulations
(Draft for Review)", which officially incorporated the medical device MAH
system into the regulations
2019-08-01
the NMPA issued the "Notice on Expanding the Pilot Work of MAH System"
([2019] No. 33)
38. www.cirs-group.com
Is this a
medical device
product?
Registration Testing
Clinical trials
Able to
determine the
product category?
Is the product
exempted for
the clinical trials?
Do you have
agent in China?
- Medical devices should be listed in the country of origin.
- Determine the corresponding product classification
according to Catalog/ apply for the classification
determination.
- Find a Chinese agent/ establish a Chinese subsidiary
- Change of agent does not require signature of original agent
- For Biological test, overseas GLP report can be used, with
the laboratory qualification certificate.
- In the catalog of medical devices exempted from clinical
trials
- Analytical evaluation by data obtained from clinical trials or
clinical application of medical devices of the same variety
- Clinical evaluation with overseas clinical data
- Clinical trials
39. www.cirs-group.com
Technical review,
Administrative
review
Registration
certificate
QMS audit
- For Quality Management System, GMP certification is
required, and there will be QMS verification during the
registration process
- Keep the original registration certificate
- Keep the materials of the first registration
- The change or renewal of the registration certificate
needs to be applied at least six months before its
expiration.
- Gap analysis before production
41. www.cirs-group.com
Medical Devices Clinical Evaluation
- Clinical Trials for Medical Devices
and IVD
- Pre-Clinical Investigation of
Medical Devices
- Clinical Trial Protocol Design for
Medical Devices
- Clinical Trials Auditing and Quality
Assurance
- Data Management and Statistical
Analysis
- Draft Clinical Trial Report and
Clinical Evaluation Report
- Medical Device Clinical Monitoring
Medical Devices Registration
- Regulatory Compliance Assessment
an Registration Consulting
- Product Classification, Attributes
Define and Registration Proposal
Confirmed
- Registration (Recording) for
Medical Devices and IVD
- Registration Certificate Update and
Renewal for Medical Devices and IVD
- Coordinate the Registration
Inspection and Commissioned
Inspection
- Compilation and Submission of
Technical Construction File
Medical Devices Quality
Management System Service
- Initial Analysis and
Confirmation when QMS
Establishing
- QMS Designing and Consulting
- QMS Establishment and
Operation Consultation
- Training of QMS and QMS Self-
inspection
- QMS on-site Audit and
Correction Consultation
- ISO 13485 QMS Establishment
and Consultation
What Can We Offer
Market size is on the rise
This demonstrates the significant growth potential of the sector.
Highest authority
DI is compulsory
The (UDI) is the electronic ID card of the medical device product. The carrier is the medium for storing or transmitting the UDI. The database is a database for storing the product identification and related information uniquely identified by the medical device. The three together form the UDI system.
, which will help guide registered applicants to submit medical device registration information. Prepare and rely on the information system to facilitate the registration of the administrative counterparts.
It is easy to have some mistaken operation in the system.
This Notice Extending the pilot scope of the medical device marketing licensee system to Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Guangxi, Hainan, Chongqing, Sichuan, Yunnan , Shaanxi and other 21 provinces and cities.
Pay attention to relevant information of similar medical device products already listed in China.(Clinical evaluation)
If the product is required for clinical trials in the country of origin, you can set up international multi-center clinical trials and put one of the centers in China.(Overseas clinical data)
体系检查:The system inspection of overseas companies is generally a document review, but sometimes there will be a onsite-audit.
缺口分析: Because some medical device technical standards or industry standards will have some differences between China and foreign countries