for the USA, EU and China

Ibim Tariah

John Beasley

Presenters

Kevin Morningstar

John Beasley

CHINA MEDICAL DEVICE

REGULATORY PROCESS

Please Note
The information contained in this presentation is
intended for general regulatory planning.
Chinas regulatory system is currently under
change. Companies are strongly encouraged to
work with professional organizations familiar with
the most current regulatory environment for their
specific needs.
Translations of laws and regulations are unofficial.

Topics

Regulatory Agencies in China

Summary of Laws and Regulations
Labeling Requirements
Important Documentation and Procedures

Presented in relation to Summary Technical Document (STED) of GHTF


connections

Guanxi

relationships

a state of general understanding between two

individuals: he is aware of my needs and will
take them into account when deciding the
course of future actions which concern or
could concern me without any specific
discussion or request.
is the basic dynamic in personalized networks of influence

Regulatory Agencies in China

Three Chinese agencies have regulatory
roles for imported medical devices.
State Food and Drug Administration (SFDA)
Ministry of Health (MOH)
General Administration of Quality Supervision,
Inspection and Quarantine of the Peoples
Republic of China (AQSIQ)
Involvement of other agencies is required for specific devices i.e., Safety
Quality Licensing Office for Import Boiler and Pressure Vessels (SQLO)
certificates, China National Certification and Accreditation Administration
(CNCA)

Websites
Agency

Website

SFDA

h'p://www.sfda.gov.cn

AQSIQ

h'p://www.aqsiq.gov.cn

MOH

www.moh.gov.cn

English

English?
Updated monthly
PR Announcements
Some translations of regulations
provided (in Chinglish)

Which version of the standard?

,

,

,
,

,
,,
,

2. Should changes occur to the national

standards or industry standards for which the
product standards are adopted from or
referenced from, those medical devices which
had received registration approval before the
issuance of the new standards shall be
examined, reviewed and approved according to
the original standards, except in situations
whereby the safety and efficacy of the medical
device would be substantially affected by the
changed
standards,
and
when
other
requirements already exist in regulations within
SFDA-released and implemented national or
industry standards.
However, after the company has acquired the
registration certificate and upon the validation of
the new standards, the medical device should be
manufactured according to the new version, and
the product standard code of approval must be
included in the product instructions, labels and
packaging of the product.

Frustrated Industry

State Food and Drug Administration

Regulation of medical devices
Roughly equivalent to the U.S. Food and
Drug Administration
All imported medical devices must get a
registration certificate from SFDA
The SFDA has a comprehensive system
for medical device registration and
inspection, which includes product type
testing and factory audits.

Ministry of Health
The Ministry of Health (MOH) is in charge
of
drafting laws, regulations, and policies related
to public health,
overseeing the administration of Traditional
Chinese Medicine, and
for administering Chinas rural health
insurance system.

General Administration of Quality Supervision,

Inspection and Quarantine

AQSIQ is tasked with overseeing

inspection, quarantine, and establishing
the technical standards of goods for import
and export.
AQSIQ maintains responsibility for
certifying electrical safety for a wide
variety of products, including some
electro-medical devices

Laws and Regulations

The Regulations for the Supervision and
Administration of Medical Devices, Order
276, enacted in April 1, 2000, is the
fundamental law governing Chinas health
sector.
The regulations have been amended on
several occasions by RED LETTERS

Amendments

Amended Order 276

September 6, 2010
Regulation on Supervision and Administration of
Medical Devices (Amendment Bill)
(Draft for Public Comment)

Consolidation of
Red Letters
Clinical Trail, Manufacturing, Recall, and other
regulations
Increases from Six Chapters, Forty-eight Articles to Nine Chapters, Eighty-eight Articles

Labeling Requirements
On July 8, 2004, SFDA issued a regulation
titled Provisions for the Instructions,
Labels and Package of Medical Devices
which lays out requirements for labeling.
must be labeled in Chinese
include the registration certificate number
product features
the scope of usage for the product
These labels should be affixed to products before going through customs.

Labeling Prohibitions

Best effect of treatment",

"Full recovery guarantee",
"Immediate effect",
"Without toxicity and side-effect,
"Money back if not effective,
Highest technology",
Most scientific",
Most advanced, and
The best.

In addition
Specifications, labels and marks of medial
devices can not state
cure rate or efficacy rates,
comparisons to the efficacy and safety of one manufacturers
products with anothers.
any firms or individuals name or image for the purpose of
approval or recommendation
expressions which make people feel that they have attracted
certain disease, or
expression which mislead people into feeling that they would
contract a certain disease, or their disease could get worse by
not using this medical device.

Who Submits the Registration Application

China issues registration certificates and

licenses in the name of the device
manufacturer
not to the agent or distributor.

Companies should arrange for their agent or distributor to hand over the
registration certificates (licenses).

What Medical Devices Need to be Registered

Class I Medical Devices are those for which safety and
effectiveness can be ensured through routine
administration;
Class II Medical Devices are those for which further
control is required to ensure their safety and
effectiveness
Class III Medical Devices are 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.
Class I devices are RECORDED; Class II and Class III devices are REGISTERED

What Risk Category is the Device?

What Risk Category is the Device?

Three characteristics described in
guidelines
(1) The structural characteristics of medical devices
Active or Passive
(2) The forms of operation of medical devices
Passive devices are used for transportation and storage of
pharmaceutical liquid; devices for alteration of blood or body fluids;
medical dressings; reusable or disposable surgical instruments;
disposable aseptic devices; implantable devices; devices for
contraception and birth control; devices for sterilization and
cleaning; patient care devices; in vitro diagnostic reagents as well
as other passive contacting devices or passive supplementary
devices

What Risk Category is the Device?

(2) The forms of operation of medical devices
(continued)
Active devices are devices for treatment through
energy, diagnostic monitoring, body fluid
transportation and ionized radiation, laboratory
instruments and medical sterilizer; as well as other
active contacting devices or active supplementary
devices.

What Risk Category is the Device?

(3) The conditions for use of medical devices
Contacting or inserted devices
Term of use: temporary use, short - term use, long-term
use;
Particular parts of the human body being contacted:
skin, cavity and tract; trauma or body tissue; blood
circulation system or central nervous system;
The degree of injuries caused by malfunction of active
devices:
minor injuries, injuries, serious injuries.

Non-contacting Devices
SFDA also has a classification catalogue for medical devices (in Chinese) which provides
more information regarding which classification a device falls under.

How to Demonstrate Conformance with Chinese

Standards

Chinese law requires each industrial

product to have a Chinese national
standard.
The Chinese national standard is usually the
same as the relevant international standard,
although sometimes with minor modifications.
Medical devices type testing must be based
upon the Chinese national standard.

How to Demonstrate Conformance with Chinese

Standards

However, if a national standard does not exist,

an industry standard, or a company-specified
standard may be used.
Chinese testing laboratories work with
companies to ensure that their company-specific
standard are in-line with relevant national
standards.

 The medical device standards are

classified as
national standards (GB),
industry standards (YY) and
registration product standards (YZB).

Standards
China medical devices standards are separated into
compulsory standards and recommended standards,
which differ from international standards.
The difference in the standard code between compulsory
standards and recommended standards is whether /T follows
GB or YY.
GB and YY are compulsory standards
GB/T and YY/T are recommended standards

Compulsory standards have the attribute of law and must be implemented.

Example: Infusion Pump

Example: Infusion Pump

Compulsory

Identical to ISO;
Otherwise would read MOD

Standards
National standards are established and applied for
regulating technology requirements nationwide.
Industry standards are established for certain industries
which has no national standards but need standard
technology requirements within the industry.
Registration product standard is a document developed
from technical documents/standards, presented when
applying for medical device product registration, which
states the quality and technical requirements for
declared products.

Internet Resources
National medical devices standards can
be found at National Standardisation
Technical Committees' website
www.sac.gov.cn

Industry standards can be found at State

food and Drug Administration website
www.sfda.gov.cn

and Centre for Medical Device Evaluation

www.cmde.org.cn

Testing Labs
For first-time registration with SFDA, a company is
required to provide a testing report for the product by a
Chinese lab and clinical trial report (for certain high risk
products) with clinical data based on the clinical trials
from two medical institutions. The company is also
required to submit a product standard according to
Chinas Product Regulation Standard, for SFDAs
record.
If a laboratory cannot test a device (due to the lack of a
Chinese National Standard, or because the companyspecific standard is beyond the labs testing capability),
SFDA will accept tests conducted in the products
country of origin.

Testing Labs
However, U.S. companies have noted that in the past these
laboratories have required that the company-specific product
standard (product specifications, testing methods and specifications)
be submitted for review and approval prior to testing being done by
the lab.
In some cases, labs have insisted that the company-specific product
standard did not meet their format, and have tried to get companies
to pay a fee to have the standard re-written in a manner that makes
it possible for the lab to do the test itself.
In the past, laboratories often attempted to perform the required
testing without the proper facilities or knowledge, which were not
always accepted by SFDA. In many cases, SFDA found those tests
to be insufficient and requires new tests.
Although labs are required to complete their testing within one month, this often
takes between 4 to 5 months to complete.

Testing Labs
SFDA has certified ten testing laboratories
as technologically competent to perform
the required tests in an effort to alleviate
these problems.

Testing Labs

Beijing Center for Medical Device Quality Supervision and Testing

Medical Device Quality Supervision and Testing Center of Peking University
( Beijing)
Center for Medical Devices - National Institute for the Control of
Pharmaceutical -- Biological Products ( Beijing)
Shanghai Center for Medical Equipment Quality Supervision and Testing
Tianjin Medical Instrumentation Inspection Center
Wuhan Quality Supervision and Testing Center for Medical Devices
Jinan Quality Supervision and Inspection Center for Medical Devices
Shenyang Center for Medical Equipment Quality Supervision and Testing
Guangzhou Quality Supervision and Inspection Center for Medical
Instruments
Hangzhou Center for Medical Equipment Quality Supervision and Testing

Test Labs
With the medical device industrys rapid growth,
however, the centers have been hard-pressed to
keep up with increasing demand.
As SFDA has tightened regulations and raised
medical device registration standards, the
centers have had to perform significantly more
tests more thoroughly.
Current testing facilities have insufficient
resources to meet these requirements efficiently,
prompting industry complaints about the slow
registration process.

"China Compulsory Certification

Seven categories of electro-medical device
products require CCC certification:

Electrocardiographs;
Hemodialysis equipment;
Extracorporeal blood circuit for blood purification equipment;
Hollow fiber dialyzer;
Implantable cardiac pacemakers;
Medical x-ray diagnostic equipment;
Artificial heart-lung machine.

CCC mark certification requires a factory inspection by Chinese officials at the

applicants expense, as well as follow-up inspections.

The Regulations for the Supervision and Administration of

Medical Devices, Order 276

Article 8
The State shall
implement a product
registration system for
the manufacturing of
medical devices.

Making use of the STED

Borrowing from the
Pharmaceutical CTD Triangle

Making use of the STED

Module 1:
Geographic
Specic
DocumentaGon

1.
2.
3.
4.
5.
6.
7.
8.

Application form
Business license of manufacturer
Letter of authorization for registration agent
Letter of authorization for after-sales agent
Letter of promise from after-sales agent
Quality Guarantee Letter
Truthful and Accuracy of Submission Statement
Fees

Section 1: Summary of Device

and Approvals
Section 2:
Essential
Principles

Section 5: Labeling,
Instructions,
Advertisement

Section 3: Device
Description

Section 6: Risk
Analysis

Section 4:
Design V&V
Documents

Section 7:
Manufacturing
Information

Making use of the STED

Module 1:
Geographic
Specic
DocumentaGon

1.
2.
3.
4.

Outline of device
Origin/history of discovery and development history
Use in foreign counties (complaint information)
Manufacturing authorization document in the country of origin

Section 1: Summary of Device

and Approvals
Section 2:
Essential
Principles

Section 5: Labeling,
Instructions,
Advertisement

Section 3: Device
Description

Section 6: Risk
Analysis

Section 4:
Design V&V
Documents

Section 7:
Manufacturing
Information

Making use of the STED

Module 1:
Geographic
Specic
DocumentaGon

1. List of referenced standards (GB, YY, GB/T, etc.)

2. Check list of conformity
3. Description of conformity

Section 1: Summary of Device

and Approvals
Section 2:
Essential
Principles

Section 5: Labeling,
Instructions,
Advertisement

Section 3: Device
Description

Section 6: Risk
Analysis

Section 4:
Design V&V
Documents

Section 7:
Manufacturing
Information

Making use of the STED

Module 1:
Geographic
Specic
DocumentaGon

1.
2.
3.
4.

General information/materials
Specifications and rationale
UBD and storage condition
Comparison to predicate device

Section 1: Summary of Device

and Approvals
Section 2:
Essential
Principles

Section 5: Labeling,
Instructions,
Advertisement

Section 3: Device
Description

Section 6: Risk
Analysis

Section 4:
Design V&V
Documents

Section 7:
Manufacturing
Information

Making use of the STED

Module 1:
Geographic
Specic
DocumentaGon

1.
2.
3.
4.
5.

Conformity declaration to standards and QS regulations

Design verification related to safety
Performance data
Clinical data
YZB Report from Type Test Lab

Section 1: Summary of Device

and Approvals
Section 2:
Essential
Principles

Section 5: Labeling,
Instructions,
Advertisement

Section 3: Device
Description

Section 6: Risk
Analysis

Section 4:
Design V&V
Documents

Section 7:
Manufacturing
Information

Making use of the STED

Module 1:
Geographic
Specic
DocumentaGon

1.
2.
3.
4.
5.

Final Draft IFU

Rationale of indication
Rationale of operation method
Rationale of precautions
China regulatory labeling specifics

Section 1: Summary of Device

and Approvals
Section 2:
Essential
Principles

Section 5: Labeling,
Instructions,
Advertisement

Section 3: Device
Description

Section 6: Risk
Analysis

Section 4:
Design V&V
Documents

Section 7:
Manufacturing
Information

Making use of the STED

Module 1:
Geographic
Specic
DocumentaGon

1. Organization of risk management

2. Conduct of risk analysis
3. Critical hazard and correction actions

Section 1: Summary of Device

and Approvals
Section 2:
Essential
Principles

Section 5: Labeling,
Instructions,
Advertisement

Section 3: Device
Description

Section 6: Risk
Analysis

Section 4:
Design V&V
Documents

Section 7:
Manufacturing
Information

Making use of the STED

Module 1:
Geographic
Specic
DocumentaGon

1. Manufacturing process flowchart

2. Sterilization method
3. Information on quality control

Section 1: Summary of Device

and Approvals
Section 2:
Essential
Principles

Section 5: Labeling,
Instructions,
Advertisement

Section 3: Device
Description

Section 6: Risk
Analysis

Section 4:
Design V&V
Documents

Section 7:
Manufacturing
Information

GROUP EXERCISE
IBIM TARIAH