Medidynamic - medica

Hello, everyone. We are an international medical device consulting firm
with headquarter locating in Seattle, United states and we have offices
in Beijing, China as well. Since our company establishment in 2002,
with our extensive distributor database nationwide in China territory
and excellent relationship with hospitals and medical regulation
authorities (SFDA), we have been successfully helping a large number of
international companies, in particular, orthopaedic and surgical
manufacturers in developing business in China, these companies are
generally from USA, Japan, Czech,Australia, France and Germany etc.

We
have been actively attending international medical exhibitions around
the world including Medica show held in Germany, AAOS(American academy
of orthopaedic surgeons) etc.

Here is our company profile below:

Introduction

China is recognized as one of the most important medical growth markets of
the 21st century, but succeeding in China can be difficult. These days,
Chinese consumer preferences, regulatory requirements, and disease profiles
are all changing rapidly. Business strategies that work well today may become
obsolete after just a few years. MediDynamic has the experience necessary to
help you excel in China.

MediDynamic
can assist medical companies in developing their China business and
marketingstrategies. Each strategy is tailored to the company's
specific goals and objectives.

MediDynamic can help those newly entering the Chinese medical market as well as those
interested in expanding their existing China operations.

MediDynamic
examines a wide range of issues, including: market demand; prospects
for growth,analysis of key partners/distributors, etc.

Company Profile
MediDynamic LLC is a medical device consulting firm with offices in the United
States and China. By focusing on providing outstanding service and value for
companies/manufactures who are interested in developing business in China,
we have grown to become one of the leading medical device regulatory and
marketing consultants with expertise in China SFDA registration, marketing
research, in-country distribution representation and many other areas. Major
services we are offering include:

1. Product registration:
The medical device market in China is worth about $7.5 billion. The regulator of medical
devices in China is the State Food and Drug Administration (SFDA), which handles
medical device product registration as well as many other regulatory issues.
From
year 2000, SFDA began to strengthen the supervision and administration
of medicaldevices. All imported medical devices in China (including
Class I medical devices) must be approved directly by SFDA, any
equipments or supplies without certificate will be prohibited to be
sold or used in China. This registration process is getting more and
more complicated since year 2003, it will take about one year period to
get it approved. This is a prerequisite condition needs to be fulfilled
in the whole promoting process. MediDynamic can act as your legal and
after sales agent in China. Our expertise will helpyou navigate the
Chinese regulatory system, achieve medical product registration, and
access the huge Chinese medical markets. We will help you register your
medical product in a cost-effective and timely way.

Through our office in Beijing, MediDynamic can help you obtain SFDA approval for your
medical device. Our specialists in Beijing work directly with the SFDA on regular basis,
coordinating the submission of regulatory documents, answering SFDA follow up
questions and providing insight on how to navigate the evolving regulatory landscape in
China.
Generally, we can help you with these China medical device regulatory issues:
· Determine device classification.
· Ascertain the best route to SFDA approval in China.
· Development of a Product Registration Standard.
· Develop clinical protocols and coordinate clinical trials, if required.
· Translate documents and labeling.
· Obtain the CCC Mark, if required.
· Prepare final submissions
· Handle incident reporting, SFDA inspections and device registration renewals.
Up to the present, we maintain 100% of success on completion of the complicated
registration procedure. Our qualified personnel well connected with SFDA will be able to
provide you with all the information about the regulations and provisions as well as the
step-by-step instructions including classification method, document list and pricing list
related to the registration process. We have been very successfully cooperating with
many famous manufacturers from United States and Japan as their registration agency in China.
2. Local channel sales and partnership setup (distributor identification):
As everyone knows, China is an enormous market with 1.3 billion people, over 300,000
hospitals and more than 161,000 medical distributors. The city of Beijing has 7,700
medical distributors and Shanghai has 5,700, respectively. In the rapidly expanding
Chinese
medical market, there are many local Chinese distributors ready to take
on your medical device, but not all of them are qualified or
trustworthy. To take full advantage of the Chinese economic boom and to
protect your intellectual property, it is vital to find the right
distributor.

Through assistance given by our office in Beijing, we can assist medical device
manufacturers with finding and analyzing medical distributors in China. Our experienced
marketing team has plenty of sources and channels to locate the matching candidates,
figuring out their actual sales strength and financial capabilities accurately and selecting
the best one. Clients will get the satisfied partner more efficiently and save the budget for sure.

Plus, we will be able to not only meet this requirement, but should give full assistance to
the operation process after the selecting task is done. Based on our past seven years
experience, we are familiar with all kinds of problems could be happened during each
stage of operations, we know the proper solution and ways to tackle them in order to
increase sales smoothly. This will ease both clients and its local partners to be able to
focus more energy on its core capabilities.

3. Market research and feasibility analysis:

China's medical market is one of great contrasts. While the countryside has rudimentary
healthcare, the major cities like Beijing and Shanghai have sophisticated facilities
approaching Western standards. Everywhere in China between these two extremes is
developing
at a very rapid pace too. The medical market in China is changing
greatly as it grows, making careful market research is a key to your
success there.

MediDynamic will give full assistance to clients to do market research on their core
product system. It will include:

a) Current market investigation report. This will give clients a comprehensive idea
of its product market status in China.

b) Feasibility analysis for entering into China step by step. It contains information
such as:
i. Feasibility methodology for marketing and selling promoted system in China.
ii. Selection of Distributors and management
iii. Fixation of product price in China market
iv. What sales volume should be identified in the first three years
v. How to furnish the sales target through first level and second level
distributors, etc
vi. Product registration and logistic issues in China
vii. Much more

4. Innovative products selection:
As the golden bridge between western world and China, resellers from China now have
opportunities
to know more overseas innovative technology through us. Our Seattle
team is playing the major role in locating the cutting edge product
line in the world for our clients in China. This will help them
partnering with technology based companies that features innovative
products and produce more effective outcomes at lower costs.

Please
feel free to contact us, we welcome any inquiries from you and our
sales specialist will get back to you as soon as possible.

Sales specialist: Shawn Liu

Contact information:

Phone number: Either +86 13718364590 (China)
Or +61 (0)430277436 (Australia)

Email address: shawn.liu@medidynamic.cn

Website: www.medidynamic.com