China: Medical Device Regulations

China: Medical
Device Regulations
Pacific Bridge Medical

2013 White Paper

www.pacificbridgemedical.com

China: Medical
Device Regulations

2013 White Paper

Copyright © 2013 Pacific Bridge Medical. All rights reserved. This content is protected
by US and International copyright laws and may not be copied, reprinted, published, translated, resold, hosted, or otherwise distributed by any means without explicit permission.
Disclaimer: the information contained in this report is the opinion of Pacific Bridge Medical, a subsidiary of Pacific Bridge, Inc. It is provided for general information purposes
only, and does not constitute professional advice. We believe the contents to be true and
accurate at the date of writing but can give no assurances or warranties regarding the accuracy, currency, or applicability of any of the contents in relation to specific situations and
particular circumstances.

Map of China

Copyright © 2013 Pacific Bridge Medical

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Medical Device Market
❖ China is the 7th largest medical device market in
the world – soon to be the 4th largest
♦ It is valued at approximately USD $9.0 billion

for 2011


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China: Medical Device Regulatory
Authorities
❖ State Food & Drug Administration (SFDA)
♦ Founded in 1998.
♦ Equivalent to the U.S. FDA.
♦ Responsible for medical devices, drugs, and

healthcare services.

♦ Headquarters is located in Beijing, with offices

in each province also.

❖ General Administration of Quality Supervision,
Inspection and Quarantine (AQSIQ)
♦ Conducts mandatory safety registration,

certification, and inspection for certain devices.


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SFDA: Medical Device Department
Department of Medical Device Supervision

Division of
General
Affairs

Direct
Affiliation

Division I
of
Registration

Division II
of
Registration

Division of
Manufacturing
& Distribution
Supervision

Division of
Research &
Reevaluation

Center of Medical Device Evaluation
(CMDE)
Division of Medical Device
Provincial FDA

Indirect
Affiliation

Certified Test Centers in Key Provinces


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Legal Agent
❖ Must be a registered entity in China
❖ Must provide the following services:
♦ Report adverse events in China to SFDA

according to China’s regulations

♦ Act as the coordinator between the foreign

company and the SFDA

• This also requires reporting of adverse events
that occur outside of China to SFDA according
to China’s regulations

❖ Handle any recall issues in China (if any)


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After Sales Agent
❖ Party that provides technical support after product
is registered
❖ Business license must include this statement:
♦ “provides technical service and support for

device products”


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Registration Agent
❖ Submits registration/re-registration documents to
SFDA
❖ Key individual/organization that SFDA will contact
throughout registration process.


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Medical Device Classification
❖ Device Classification is the basis for determining
regulatory requirements:
♦ Class I – Those which safety and effectiveness

can be ensured through routine administration.

♦ Class II – Those which further control

is required to ensure their safety and
effectiveness.

♦ Class III – Those which are 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.


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Official Medical Device Classification
❖ For innovative products and combination products,
getting an official SFDA classification can be very
helpful.
♦ Trying to go through product registration

with certain products without an official
classification can sometimes cause delays,
more troubles. The SFDA would issue an
official written classification that it CANNOT
take back.

❖ The process can take from 3 to 6 months, but the
SFDA in general has been very slow in this regard.


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China Product Registration:
Key Points
❖ Third Party Review not allowed; need approval
from the SFDA.
❖ Some classifications are different from the U.S.
❖ Class 1 Medical Devices also need SFDA approval.
❖ Need to submit Chinese Specification for SFDA
review and approval.


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New Class II products that do NOT
require clinical trials Product
Registration Process
Normal Timeline
1. Chinese Specification Drafting

Dossier Preparation &
Specification Drafting

Depends on the Company
and Product

4 - 5 Months

Sample Testing

5 working days

Filing to SFDA

3 months

3 - 5 months

2. Sample Testing

3. SFDA preliminary review &
issues acceptance notice
4. CMDE review

No

5. SFDA final approval

CMDE
Review
Yes

Approximate Total

10 - 13 months


SFDA Final Approval

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Product Standard
❖ The Product Standard is the most important part of
the registration:
♦ Because the product standard is not reviewed

by the CMDE before testing, sample testing is
done on the company’s product standard.

♦ If the testing result is deemed unsatisfactory,

the CMDE/SFDA may request the company to
revise the product standard and re-test.

♦ Also, the SFDA will refer to the product

standard to determine if different models can
be registered under one import device license.

❖ Therefore, make sure to provide sufficient
information to support the drafting of Chinese
product standard by the registration agent


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Product Standard (cont’d)
❖ The product standard should describe the product
and include the appropriate Chinese standards it
complies with.
❖ Many of the Chinese standards correspond to
international standards.
❖ Standard Classifications
♦ National Standards (GB, GB/T)
♦ SFDA Standards or Industry Standards

(YY, YY/T)

♦ Product Registration Standards (ZCB)

❖ Standard Categories
♦ Basic Standards
♦ Safety Standards
♦ Product Standards


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Type Testing
❖ In almost all situations, the SFDA will request
samples for type testing.
❖ The testing centers will use the Product Standard to
determine what tests to conduct.


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Bundling Products
❖ Bundling accessories with products is possible for
registration.
❖ Make sure to develop Product Standard
accordingly.


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Renewing Your Registration
❖ Product registration is valid for 4 years.
❖ Renewal application must be submitted 6 months
before import license expires. Start process 1 year
in advance.
❖ Renewal process is similar to a new application.
❖ Sample testing should be repeated again.
❖ Post-market quality and safety surveillance report is
required.


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Registration Requirements for Dossier
❖ Total 13 items of documents must be collected and
submitted to the SFDA.
❖ Three parts of these 13 items:
♦ Legal Documents (9).
♦ Technical Documents (3).
♦ Testing report issued by SFDA certified testing

center (if applicable).

❖ Documents must be in both Chinese and English.


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Testing Report
❖ Testing Report:
♦ Issued by SFDA certified testing center.
♦ Testing Center can be freely selected from the

SFDA list.

♦ Must be valid (the testing report is only valid

for 1 year). So if it expires, you need to start
again.


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Adverse Event Reporting for MDs
❖ Strengthening Adverse Drug Reaction Monitoring
❖ Specifies which governmental agencies are
responsible for which aspects of medical device
adverse event monitoring and re-evaluation
❖ All medical device manufacturers, distributors,
and medical institutions must establish internal
supervision systems for medical device adverse
event monitoring.


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Clinical Trials for Products Not Yet
Registered in China
❖ The SFDA has been organizing expert review
meetings with top doctors to determine if clinical
trials are required for product registration.
❖ More and more, the SFDA has been getting stricter
in requiring local clinical trials, even for some Class
II products.


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Clinical Trials in China
❖ All clinical trials (if necessary) for medical devices
must follow China’s Good Clinical Practices
(GCP).
❖ Regulation on Medical Device Clinical Trial
Requirements became effective April 2004.
❖ Can only draw on previous clinical trial experiences
of similar products.


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Thank You!
Connect with us today.
7315 Wisconsin Avenue, Suite 609E
Bethesda, MD 20814
Click here to contact us for medical device
regulatory assistance in China.


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China: Medical Device Regulations

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