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/.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
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.
plasma master file in European countries and requirements in letter of intent...Sanjay batra
it includes that what is plasma master file, principles, procedure to file PMF, strategy involved, administration information, certification procedure & inspection
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/.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
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.
plasma master file in European countries and requirements in letter of intent...Sanjay batra
it includes that what is plasma master file, principles, procedure to file PMF, strategy involved, administration information, certification procedure & inspection
GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration process (SA), Drug Registration Requirement (SA), Post Registration Requirements in (SA), Drug registration regulations UAE Medicinal Product Registration process (UAE), Drug Registration Requirement (UAE).
Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products.
SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products.
The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
SFDA prefers the drug dossier submission in electronic format (eCTD).
It is an independent authority from the Ministry of Health.
Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees.
Upload the eCTD file to the system through the SDR system portal.
A soft copy of the eCTD should be submitted labelled as per the SFDA guideline, along with the hard copies of the original documents.
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people.
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.
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
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.
Japan Medical Device Regulatory Approval ProcessKate Jablonski
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, outlines 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)
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREME...Mohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA 201T)
Semester II - Regulatory Aspects of Drugs and Cosmetics (MRA 201T)
Unit V - Regulatory pre-requisites related to Marketing authorization requirements for drugs and post approval requirements in Saudi Arabia
(REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREMENTS IN SAUDI ARABIA)
Drug approval process in Saudi Arabia - Saudi Food & Drug Authority
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).
GCC countries, Drug registration regulations of Saudi Arabia, Medicinal Product Registration process (SA), Drug Registration Requirement (SA), Post Registration Requirements in (SA), Drug registration regulations UAE Medicinal Product Registration process (UAE), Drug Registration Requirement (UAE).
Since 2003, The Saudi Food and Drug Authority (SFDA) is the competent authority for registrations, maintenance, quality, pharmacovigilance and import of medicinal products.
SFDA is responsible for handling and licensing the manufacture, import, export, distribution, promotion, and advertising of medicinal products.
The SFDA is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and monitoring the quality & safety of the marketed medicinal products.
SFDA prefers the drug dossier submission in electronic format (eCTD).
It is an independent authority from the Ministry of Health.
Market Authorization
The process of submitting a new Marketing Authorization Application (MAA) consists of the following phases:
Phase 1
Step 1: Online Registration on the Drug Establishments National Registry (DENR)
The applicant register online on the DENR to get a username and password, which enables the applicant to log in and avail all the electronic services of the drug sector.
Step 2: Marketing Authorization Application (MAA) Submission:
The applicant shall apply through the Saudi Drug Registration (SDR) system to fill out the application form and pay the fees.
Upload the eCTD file to the system through the SDR system portal.
A soft copy of the eCTD should be submitted labelled as per the SFDA guideline, along with the hard copies of the original documents.
Phase 2
Step 1: Validation
The product file will be validated on technical and business bases to ensure that the applicant fulfils the requirement.
Step 2 - Assessment, Testing and Inspection
The relevant departments will evaluate the MAA to assess quality, safety, and efficacy, along with the onsite GMP inspection and sample analysis by the SFDA central laboratories.
Step 3 - Pricing
The Pricing Department will review the product’s price according to the “SFDA's pricing rules.”
Step 4 - Product Licensing
The Registration Committee will review the registration request for approval.
Verification and Abridged Procedure
Verification Process
This process will be applicable if the product has been approved and marketed by both the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA).
For all pharmaceutical items, even those that are not intended to be used as medicines, such as nutritional supplements and cosmetics, to be registered with the Ministry of Health & Prevention (MOHAP) in the United Arab Emirates.
The UAE government takes all necessary measures to ensure that safety standards and procedures are followed in cases of import, export, trade, and sale of products, which are consumed or used by the people.
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.
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
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.
Japan Medical Device Regulatory Approval ProcessKate Jablonski
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, outlines 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)
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREME...Mohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA 201T)
Semester II - Regulatory Aspects of Drugs and Cosmetics (MRA 201T)
Unit V - Regulatory pre-requisites related to Marketing authorization requirements for drugs and post approval requirements in Saudi Arabia
(REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS AND POST APPROVAL REQUIREMENTS IN SAUDI ARABIA)
Drug approval process in Saudi Arabia - Saudi Food & Drug Authority
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).
An Overview of CDSCO Registration. The CDSCO stands for Central Drugs Standard Control Organisation is the NRA or National Regulatory Authority under the Directorate General of Health Services, Government of India, and Ministry of Health and Family Welfare.
My presentation based on the CDSCO certification, as well as the complete description about the CDSCO and DCGI.
An Overview of CDSCO Registration. The CDSCO stands for Central Drugs Standard Control Organisation is the NRA or National Regulatory Authority under the Directorate General of Health Services, Government of India, and Ministry of Health and Family Welfare.
My presentation based on the CDSCO certification, as well as the complete description about the CDSCO and DCGI.
Different drug regularity bodies in different countries.kishan singh tomar
Various countries around the world have distinct drug regulatory bodies tasked with overseeing the safety, efficacy, and quality of pharmaceutical products within their borders. These regulatory agencies play a crucial role in ensuring that medications meet stringent standards before they reach consumers. In the United States, the Food and Drug Administration (FDA) is renowned for its rigorous evaluation processes, conducting thorough reviews of drugs before granting approval for distribution. Similarly, the European Medicines Agency (EMA) serves as the regulatory authority for the European Union, overseeing the approval and supervision of medicines across member states.
Other countries have their own equivalents, such as Health Canada's Health Products and Food Branch (HPFB) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). These bodies conduct comprehensive assessments of drugs through clinical trials, inspections of manufacturing facilities, and ongoing surveillance of adverse events. Additionally, they establish guidelines for labeling, packaging, and advertising to ensure transparency and consumer safety.
Despite differing in structure and procedures, these regulatory bodies share a common goal of safeguarding public health by upholding stringent standards for the pharmaceutical industry. Collaboration and communication between these entities are essential for fostering global consistency in drug regulation and promoting access to safe and effective medications worldwide.
Federal Regulatory Issues Us Food And Drug Administration Medical Device Amen...Jacobe2008
Authors:
Harvard-MIT Division of Health Sciences and Technology HST.535: Principles and Practice of Tissue Engineering Instructors: Myron Spector
Massachusetts Institute of Technology
Harvard Medical School Brigham and Women's Hospital VA Boston Healthcare
Medical Device Regulations Global Overview And Guiding PrinciplesJacobe2008
WHO Library Cataloguing-in-Publication Data
World Health Organization.
Medical device regulations : global overview and guiding principles.
1.Equipment and supplies – legislation 2.Equipment and supplies –
standards 3.Policy making 4.Risk management 5.Quality control I.Title.
ISBN 92 4 154618 2 (NLM Classification: WA 26)
Statistical Issues In Medical Device TrialsJacobe2008
Authors:
George Koustenis,
FDA-CDRH
David Breiter,
Boston Scientific
Roseann White,
Abbott Vascular
George Woodworth, Univ. of Iowa
FDA/INDUSTRY STATISTICS WORKSHOP: Washington, D.C. Sept. 29, 2006
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
1. The Regulation of Medical
Devices in China
Wang Lanming
Department of Medical Devices
State Food and Drug Administration, China
April 13-14, 2005
in Washington & Boston, U.S.A
State Food and Drug Administration,China 1
2. OVERVIEW
Administrative Organizations and
Regulations
Medical Device Standardization
Supervision over Medical Device
Manufacturing
Medical Device Vigilance
State Food and Drug Administration,China 2
4. About SFDA
State Food and Drug Administration (SFDA)
founded in 2003, directly led by the State Council of
P. R. China;
Local Agencies: 31 provincial-, 433 municipality-
,1,936 county- level agencies (2,401 total);
Technical Organizations: 16 state-, 122
provincial-, 373 municipality-, 436 county- level
organizations (947 total)
State Food and Drug Administration,China 4
5. Organizational Structure of SFDA
State Council
SFDA
Dept. of Dept. of Dept. of Dept. Dept. Dept. of Dept. of Dept. of
Gene Policy & Food Food of Drug Dept. of of Drug Drug Personn Internati
ral Regulati Safety Safety Registr Medical Safety Market el & onal
Office on Coordina Supervisi ation Devices &Inspe Complia Educati Coopera
tion on ction nce on tion
State Food and Drug Administration,China 5
6. Department of Medical Devices
① Division of Standardization
② Division of Product Registration
③ Division of Safety & Supervision
Department of Drug Market Compliance
State Food and Drug Administration,China 6
7. SFDA Technical Organizations
Medical Device Technical Evaluation Center;
National Center for Adverse Drug Reactions
Monitoring;
Medical Device Quality Testing Centers;
The Technical Committee for Medical Device
Standardization
State Food and Drug Administration,China 7
8. MD Regulatory System in China
1.Regulation (issued by the State
Council)
2. SFDA Orders
3.SFDA Documents
State Food and Drug Administration,China 8
9. MD Regulations
1.Regulation
Regulation for the Supervision and
Administration of Medical Devices
State Council Order No.276 (Jan 4, 2000)
come into force as of April 1, 2000.
State Food and Drug Administration,China 9
10. 2. SFDA Orders
(1) Provisions on Classification of Medical Devices (No.15)
(2) Provisions on Medical Device Registration (No.16)
(3) Provisions on New Medical Device Approval (Interim) (No.17)
(4) Provisions on Medical Device Manufacturing Supervision &
Administration (No.12)
(5) Provisions on Medical Device Distributor Licensure
Administration (No.15)
State Food and Drug Administration,China 10
11. (6) Provisions on Medical Device Manufacturing Enterprise Quality
System Inspection (No.22)
(7) Provisions on Single Use Sterile Medical Device Supervision &
Administration (Interim) (No.24)
(8) Provisions on Instruction for Use and Labeling of Medical
Devices (No.10)
(9) Provisions on Medical Device Standardization (No.31)
(10) Provisions on Clinical Trial of Medical Devices (No.5)
State Food and Drug Administration,China 11
12. 3.SFDA Documents (Examples)
Product Classification Catalog of Medical Devices
Provisions on Cornea Contact Lens Distribution Supervision &
Administration
Detailed rules on Single Use Sterile Medical Device (syringe,
infusion) Manufacturing
Provisions on the Daily Supervision for Medical Device
Manufacturing Enterprises (Interim)
State Food and Drug Administration,China 12
13. Provisions on Qualification Certification of Medical Device Testing
Center (Interim)
Detailed Rules on Medical Device Manufacturer Licensing Practice
Detailed Rules on Class I Medical Device Registration Licensing
Practice
Detailed Rules on Class II Medical Device Registration Licensing
Practice
Detailed Rules on Class III & Imported Medical Device Registration
Licensing Practice
………
State Food and Drug Administration,China 13
14. Medical Device Registration
(presented by Mr. Chang Yongheng)
Medical Device Standardization
Supervision over Medical Device Manufacturing
Medical Device Vigilance
State Food and Drug Administration,China 14
15. 2. Medical Device Standardization
State Food and Drug Administration,China 15
16. Current Regulations
Regulation for the Supervision and Administration of
Medical Devices (State Council Order No. 276)
Provisions on Medical Device Standardization
Provisions on Classification of Medical Devices
Product Classification Catalog of Medical Devices
Provisions on Qualification Certification of Medical Device
Testing Centers (Interim) ………
State Food and Drug Administration,China 16
17. quot;Medical devicequot; Definition
Any instrument, apparatus, appliance, material, or other
article whether used alone or in combination, including the
software necessary for its proper application. It does not achieve
its principal action in or on the human body by means of
pharmacology, immunology or metabolism, but which may be
assisted in its function by such means; the use of which is to
achieve the following intended objectives:
1. Diagnosis, prevention, monitoring, treatment or alleviation of
disease;
2. Diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or handicap conditions;
3. Investigation, replacement or modification for anatomy or a
physiological process;
4. Control of conception.
State Food and Drug Administration,China 17
18. MD Classification
Class I Medical Devices: safety and effectiveness can
be ensured through routine administration;
Class II Medical Devices: further control is required to
ensure their safety and effectiveness;
Class III Medical Devices: implanted into the human
body, or used for life support or sustenance, or pose
potential risk to the human body and thus must be strictly
controlled in respect to safety and effectiveness.
State Food and Drug Administration,China 18
19. Medical Device Standards
Classification:
Basic standard, Safety standard, Product standard;
Compulsory standard (GB, YY) , Recommended standard
(GB/T, YY/T);
National standard (GB, GB/T), SFDA standard (YY, YY/T),
Registration product standard (ZCB)
State Food and Drug Administration,China 19
20. EXAMPLES
GB9706.1-1995 idt IEC60601.1:1988
Medical Electrical Equipment Part 1. General requirements for safety
GB/T16886-2001 idt ISO10993:1997
Biological evaluation of medical devices
YY/T0316-2003 idt ISO14971:2000
Medical devices-Application of risk management to medical devices
YY/T0287-2003 idt ISO13485:2003
Medical devices-Quality Management Systems-Requirements for
Regulatory Purposes
State Food and Drug Administration,China 20
21. Progress in Medical Device Standardization
• Formulation of National & SFDA standards
national standards: 134;
SFDA standards: 560
2004: national standards: 23;
SFDA standards: 68
(including NEW & REVISED)
State Food and Drug Administration,China 21
22. • Qualification certification for testing centers
2004: 27 testing centers certified;
other 7 inspections completed
State Food and Drug Administration,China 22
23. 3. Supervision over Medical
Device Manufacturing
State Food and Drug Administration,China 23
24. Current Regulations
Regulation for the Supervision and Administration of
Medical Devices (State Council Order No.276)
Provisions on Medical Device Manufacturing Supervision
& Administration
Provisions on Medical Device Manufacturing Enterprise
Quality System Inspection
Provisions on the Daily Supervision for MD Manufacturing
Enterprises (Interim) ………
State Food and Drug Administration,China 24
25. Medical Device Manufacturing
Enterprise Licensing & Informing
Manufacturer of Class II, III product;
Manufacturer of Class I II III product
State Food and Drug Administration,China 25
26. General Conditions for MD Enterprise
Operation
(1) Qualified technical staff;
(2) Manufacturing location and environment;
(3) Manufacturing equipment;
(4) Product quality testing capability (personnel,
equipment)
State Food and Drug Administration,China 26
27. Special Requirements for Enterprises of
Class II & III Products
(1) Qualification of the heads responsible for production,
quality and technology;
(2) Percentage of the technical staff in the all employees;
(3) Suitable production equipments, locations &
environments for production and storage;
(4) Suitable quality testing laboratory and capability;
(5) Keep all related regulations and technical standards
State Food and Drug Administration,China 27
28. Additional Requirements for
Enterprises of Class III Products
(1) No less than 2 internal auditors of Quality System;
(2) No less than 2 technical staff with medium-graded
technical rank and above
State Food and Drug Administration,China 28
29. Daily Supervision for Manufacturers
Provisions on the Daily Supervision for MD
Manufacturing Enterprises (Interim)
Key-Supervised Products and Manufacturers
country level-: 607 (30 products)
provincial level-: 997
State Food and Drug Administration,China 29
30. Requirements for Quality System
Detailed Rules on Medical Device Manufacturer
Licensing Practice
Provisions on Medical Device Manufacturing Enterprise
Quality System Inspection
Detailed Rules on the Production of some KEY Products
YY/T 0287 idt ISO 13485 Quality System Certification
State Food and Drug Administration,China 30
31. Principles on drafting GMP regulation
1.Reference to the Standard YY/T0287- 2003 idt
ISO 13485: 2003;
2.Integrated with the requirements in Chinese MD
regulations and relevant standards;
3.Cover all the processes including design, production,
installation, sales and service, for the Class II & III
manufacturer;
4. As regulatory requirements --- compulsory
State Food and Drug Administration,China 31
32. Framework of GMP Regulation
General rules
Implementation guidelines (by category)
Detailed implementation rules on product
manufacturing (by product)
State Food and Drug Administration,China 32
33. Responsibility for GMP
SFDA
Local agencies in provincial and below
Working Progress
◊ Sterile device
◊ Implantable device
Working Plan
State Food and Drug Administration,China 33
34. 4. Medical Device Vigilance
----Monitoring and Reevaluation
State Food and Drug Administration,China 34
35. Current Regulations
Regulation for the Supervision and Administration of
Medical Devices (State Council Order No. 276)
Provisions on Medical Device Registration
Provisions on Medical Device Manufacturing Supervision
& Administration
Provisions on Medical Device Distributor Licensure
Administration
Provisions on Single Use Sterile Medical Device
Supervision & Administration (Interim) ………
State Food and Drug Administration,China 35
36. Progress in Medical Device Vigilance
Regulatory System
Regulation for the Supervision and Administration of Medical
Devices (State Council Order No.276)
Provisions on Medical Device Registration (SFDA Order No.16)
State Food and Drug Administration,China 36
37. Provisions on Medical Device Manufacturing Supervision &
Administration (SFDA Order No.12)
Provisions on Medical Device Distributor Licensure
Administration (SFDA Order No.15)
Provisions on Single Use Sterile Medical Device Supervision &
Administration (Interim) (SDA Order No.24)
State Food and Drug Administration,China 37
39. • Pilot Program (2002.12-2004.06)
Time: Dec 1, 2002 to June 30, 2004
Medical Devices:
Cardiovascular stent;
Cornea contact len (Orthokeratology len);
Cardiac value;
Polyacrylamide hydrogel;
Orthopaedic implant
State Food and Drug Administration,China 39
40. Participants: Beijing, Shanghai, Guangdong province
plus other 5 hospitals and 8 manufactures
Totally:50 manufactures; 232 distributors;
268 hospitals were involved
State Food and Drug Administration,China 40
41. • Adverse Events Reporting (2004.07- )
until December 31, 2004
suspected case-reports: 817 (451 in 2004);
summary reports from manufacturer:
241 (143 in 2004)
State Food and Drug Administration,China 41
42. Suspect Adverse Events Case Report
National Center for ADR Monitoring
Serious injury,
Death, at once
10 days
Provincial Center for MD Adverse Events monitoring
Serious injury, Death, at once
10 days
Manufacturers, distributors, user facilities
State Food and Drug Administration,China 42
43. Summary Report for Manufacturers
National Center for ADR Monitoring
20 days
Provincial Center for MD Adverse Events Monitoring
Quarterly
Manufacturers
State Food and Drug Administration,China 43
45. Principle on the establishment of
MDV system
Go around one destination
Pay attention to two points for reference
Establish three systems
Practice four integrations
State Food and Drug Administration,China 45
46. Provisions on the Adverse Events
Monitoring and Re-evaluation of
Medical Devices (Draft)
7 chapters, 41 Articles
Chapter 1 General Provisions
Chapter 2 Organizations and Responsibility
Chapter 3 Reporting and Assessment
Chapter 4 Re-evaluation of the Product
Chapter 5 Control of Serious Events
Chapter 6 Penalties
Chapter 7 Supplementary Provisions
State Food and Drug Administration,China 46
47. Main Contents
Issued by
SFDA & MOH
Definitions
adverse event, reportable adverse
event, adverse event monitoring, re-
evaluation
Organizations and Responsibility
State Food and Drug Administration,China 47
48. Main Contents
Reporting and Assessment of Adverse
Events
Initial Report --- for manufacturer, distributor
and user facility;
Follow Report --- for manufacturer;
Summary Report --- only for manufacturer of
Class II & III products
State Food and Drug Administration,China 48
49. Manufacturer Distributor User Facility
IR-5,15d
FR-20d IR-5,15d IR-5,15d
SR-each yr
(ClassⅡ,Ⅲ) Provincial Technical Center for
Medical Device Adverse Events
IR-5,15d Monitoring
FR-15d
SR-30d
National Center for Adverse Drug
Reactions Monitoring
PSR PSR
SFDA MOH
State Food and Drug Administration,China 49
50. Main Contents
Re-evaluation of Product
Manufacturers
Regulatory Agencies and
their Technical Organizations
State Food and Drug Administration,China 50
51. Main Contents
Control of Serious Adverse Events
Distributor, User Facility
Manufacturer
Regulatory Agency
Penalties
Manufacturer, Distributor, User Facility
Medical Institution (Hospital, Clinic etc)
State Food and Drug Administration,China 51
52. Work Plan in 2005
Formulate “Provisions on the Reconditioned Medical Device
Administration
Formulate “Provisions on IVD (Medical Device) Registration”
Formulate “Detailed Rules on the Technical Review for Specific
Registration Products ” (by category)
Revise “Provisions on Medical Device Standardization”
Revise “Provisions on the Qualification Certification of Medical
Device Testing Centers”
State Food and Drug Administration,China 52
53. Formulate “Working Procedure for Drafting the SFDA Standards”
Formulate “Good Manufacturing Practices for Medical Devices” (QSR)
Formulate “Provisions on MD Adverse Events Monitoring &
Reevaluation” (MDV)
Formulate “Provisions on Medical Device Recall”
Reinforce and improve the daily supervision, in combination with the
establishment of the credibility system
State Food and Drug Administration,China 53
54. For more information
http://www.sfda.gov.cn
http://www.cmdi.gov.cn
My Email: sfdawlm@126.com
wlanming@sina.com
State Food and Drug Administration,China 54