the medical device approval process in china

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Key Points • State Food and Drug Administration (SFDA) regulatory overview

• What is a Medical Device in China • Determining device classification • Country of Origin Requirements

• Regulatory Roadmaps for Class I, II and III medical devices • Components for a Registration Dossier

• Clinical trial requirements in China • Chinese Registration Standard

• Import Medical Device Registration Certification (IMDRC) • China CCC Mark for Medical Devices

• Quality system requirements • Legal Agent and After Sales Agent requirements

• Time to Market for Class I, II and III medical devices • Additional Resources


Chinese Market Overview

Healthcare Spending in China*

• $296 billion in annual healthcare spending • $221 per capita healthcare spending • Healthcare spending increased by 182% from

2005 to 2010 • Population of 1.3 billion

* Source: World Health Organization National Health Account database


Regulatory Overview: SFDA • The Chinese medical device market is overseen by the State Food and Drug

Administration (SFDA) • The SFDA issues registration certificates for all medical devices sold in China.


What is a medical device in China?

"Medical device" is defined as 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.

Article 3 Chapter I


Determining Medical Device Classification • Medical device classification in China is determined using SFDA Order No. 15 • The device classification process in China differs significantly from those in the

European Union and the US. • A device considered Class II in the US or Class IIa/IIb in the EU could be considered

Class III in China, meaning longer and costlier registration times.


Device Classification Medical devices are classified as Class I, II or III according to the risks they

pose to patients or users.

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 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

Increasing risk to patient/user

http://www.sfda.com/medical-device.html; Article 5 Chapter I

http://www.sfda.com/medical-device.html�


Country of Origin Requirements

Approval of the medical device in the country of origin is required before you can begin your

registration effort in China. Alternatively, a US FDA 510(k) clearance will allow for SFDA

registration.


Regulatory Roadmap: Class I Medical Devices

• Class I medical devices shall be inspected, approved and granted a registration certificate by the SFDA regulatory authority of the municipalities consisting of districts.

• http://www.sfda.com/medical-device.html





Regulatory Roadmap: Class I Medical Devices

1) Appoint Legal Agent and After Sales Agent

2) Submit notarized proof of compliance with US FDA Quality System Regulation or ISO 13485

3) Prepare and submit application for Import Medical Device Registration Certificate (IMDRC) to SFDA (see follow-up slide)


Regulatory Roadmap: Class II Medical Devices

• Class II medical devices shall be inspected, approved and granted registration certificates by the SFDA regulatory authorities of provinces, autonomous regions and municipalities directly under the central government.

• Clinical evaluation must be conducted for Class II medical devices.

• http://www.sfda.com/medical-device.html





Regulatory Roadmap: Class II Medical Devices


2) Submit notarized proof of compliance with US FDA QSR or ISO 13485

3) Prepare Technical File including Indications for Use, specifications and test reports

4) Prepare Chinese Registration Standard document and submit to SFDA (see follow up slide)

5) Submit device to SFDA for testing

6) Prepare application/registration dossier (see follow-up slide)


Regulatory Roadmap: Class II, cont’d.

7) Submit registration dossier to SFDA for IMDRC

8) SFDA performs technical review and may request additional information

9) SFDA issues administrative approval

10) SFDA issues registration certificate

11) Begin marketing your device in China

12) Maintain post-market obligations


Regulatory Roadmap: Class III Medical Devices

• Class III medical devices shall be inspected, approved and granted registration certificates by the SFDA regulatory authority directly under the State Council.

• Clinical evaluation must be conducted for Class III medical devices. • http://www.sfda.com/medical-device.html





Regulatory Roadmap: Class III Medical Devices


2) Submit notarized proof of compliance with US FDA QSR or ISO 13485

3) Prepare Technical File including Indications for Use, specifications and test reports

4) Prepare Chinese Registration Standard document and submit to SFDA (see follow-up slide)

5) Submit your device to SFDA for testing

6) Prepare registration dossier (see follow-up slide)


Regulatory Roadmap: Class III, cont’d.

7) Submit registration dossier to SFDA for IMDRC

8) SFDA performs technical review, and may request additional information

9) SFDA issues administrative approval

10) SFDA issues registration certificate

11) Begin marketing your device in China

12) Maintain post-market obligations


Components of a Registration Dossier Typical components of a Registration Dossier include the following:

•Product testing reports •Clinical trial reports, if necessary

•SFDA registration form •Guarantee of product quality

•Qualification certificate for manufacturer

•Statement of authenticity of materials

•Country of origin certificate •Self-guarantee declaration

•Chinese Registration Standard •After-sales authorization

•Indications for Use translated into Mandarin Chinese


Renewal Registrations

• Except IVD reagents; there are no significant differences on timelines and costs between Renewal Registrations and New Registrations

• The filing procedure is very similar • 99% of the renewal registrations have to repeat the SFDA tests • Start the renewal registration process 2 years prior to the expiration date of the

SFDA certificate.


Reasons for Re-registration

• Manufacturer change • Manufacturing site change • Product name, model or components change • Indications for use change • Chinese registration standard (YZB) change Re-Registration is very similar to a new registration in time and process.


Clinical Trial Requirements in China


Clinical Trial Exemption

• In order to exempt your device from clinical trials, register any low risk medical device first

– This may allow your company to be exempt from a clinical trial in China, especially for future medical device registrations

• If clinical trials that produced your clinical data were conducted outside China and your device has US, EU or other national clearance/approval, SFDA will likely accept that data.


Clinical Trial Requirements in China

• The SFDA requires manufacturers of higher-risk devices to submit clinical data with their registration applications.

• In some instances, SFDA will require clinical trials to be conducted in China in order to obtain necessary clinical reference/normative data.

• For long-term implantable devices (more than 30 days), clinical trials must be conducted in China regardless of whether previous trials have been run for these devices in other markets.


“New” Clinical Trial Requirements in China

• The Regulations on the Supervision and Administration of Medical Equipments (Draft Revised Version)

• Articles 18-20 Clinical trials shall be conducted when applying registration of Class II and Class III Medical Devices.

• Implies that clinical trials will have to be conducted in China for Class III devices, and some/most Class II devices.


The Chinese Clinical Study Process

1) Collect related clinical study information (literature review) and analyze your clinical requirements.

2) Calculate sample size estimates and develop protocol design.

3) Screen clinical sites at SFDA-approved facilities and conduct feasibility analysis.

4) Finalize clinical protocol.



5) Ethics Committee (EC) submissions and approval.

6) Negotiate and sign clinical investigation contract.

7) Print Case Report Forms (CRF) and Informed Consent Form (ICF), and prepare study samples.

8) Conduct investigator meeting and training, if necessary.



9) Conduct volunteer recruitment, monitoring and quality control.

10) Follow-up visit; Serious Adverse Event (SAE) processing and reporting.

11) Conduct close-out visit; data management and study audit.

12) Finalize clinical study reports.


Chinese Registration Standard • Exporters of Class II and III devices to China must prepare and submit Chinese

Registration Standard documentation along with product samples to the SFDA Medical Device Quality Supervision and Inspection Center for testing.


SFDA Acceptance of Non-Clinical Testing • ISO 10993

• IEC60601-1/IEC61010-1 • Any test taking over 3 months • Any tests which the SFDA Lab is not competent to perform Note that everything above is negotiable with SFDA lab.


Import Medical Device Registration Certificate (IMDRC)

As long as a company has the IMDRC and places their registration number on the device label, packaging, User Manual, etc; there should be little to

no importation difficulties.


Components of an IMDRC Application

•SFDA registration form

•Qualification certificate for manufacturer

•Country of Origin certificate

•Chinese Registration Standard

•Indications for Use translated into Mandarin Chinese

•Guarantee of product quality

•Statement of authenticity of materials

•Self-guarantee declaration

•After-sales authorization

Typical components of an IMDRC application include the following:


China CCC Mark for Medical Devices

• China Compulsory Certification (CCC) applies to a broad range of products, including some medical devices with electrical components for safety conformity.

• If your device requires CCC Mark Certification, you must obtain it via testing your product in Chinese labs.

• An on-site audit of the legal manufacturer is required.


Devices Requiring Both SFDA and CCC Certification

http://www.ccc-cn.org/en/Catalogue.html

•Electrocardiograph equipment •Cardiac pacemakers

•X-ray diagnostic equipment* •Hollow-fiber dialysis accessories

•Heart-lung machines and disposables •Hemodialysis equipment

•Extracorporeal Blood Circuit for Blood Purification Equipment

•Condom

•(Mobile/Data/Multi-Media terminals) •(Information technology equipments; i.e. computers, servers)

*X-ray device need CCC only if it contains an X-ray tube.

http://www.ccc-cn.org/en/Catalogue.html�


Quality System Requirements

Compliance with US FDA Quality System Requirements and/or ISO 13485:2003 will satisfy SFDA quality management system requirements.


Legal Agent and After Sales Agent Requirements

• All medical device manufacturers selling their products in China must appoint a China Legal Agent as well as After Sales Agent.

• Your Legal Agent and After Sales Agent must be legal residents of China or maintain local business presences in China.


China Legal Agent (LA) • Your China Legal Agent interacts with the SFDA on your behalf during your

device registration process. • Your China Legal Agent serves as the primary point of contact with all

Chinese Authorities. • Your Chinese Legal Agent also assists in procuring registration renewal for

your device every four years.


China After Sales Agent (ASA) • Your After Sales Agent is responsible for reporting all incidents related to

your device to Chinese authorities in cooperation with you and your distributor following registration and commercialization of your device in China.


Can I Appoint a Distributor as my SFDA Agent?

It is possible to appoint a distributor located within China to the role of Legal Agent and After Sales Agent, there are many reasons not to do so:

– To register your device(s) you would be required to provide all to your Technical

Documentation to the distributor. Most companies prefer not to put confidential design information in the hands of a sales entity that often represents competing companies.

– The name of the After Sales Agent must be printed on your device label and Instructions for Use. If your After Sales Agent is a distributor, your other distributors will not like to see a competitor's information on your labeling.

– If you decide to switch to another distributor, are you sure the old distributor will cooperate in transferring to another Agent?

http://www.emergogroup.com/services/worldwide/independent-representation�


Appointing your Distributor as your SFDA Agent, cont’d.

– The distributor is focused on sales. Will they keep you updated on SFDA regulatory changes that may affect you?

– If SFDA questions an incident or a non-compliance that occurred involving your device or company, will your distributor defend his company or yours?

– Most distributors are not aware of the responsibilities that come with being an After Sales Agent and Legal Agent.


Estimated Costs and Time to Market: Class I

• No official SFDA fees for Class I device registration in China. • Translation fees vary depending on your documentation; but is ~$5000. • SFDA review typically takes about ~12 months.


Estimated Costs and Time to Market: Class II

• SFDA testing fees ~$8000 per device. • Translation fees can average around $5000 depending on the length of your

application. • Formal SFDA review times can take 10 to 12 months; the entire Chinese

registration process can take ~18 months from start to finish.


Estimated Costs and Time to Market: Class III • SFDA testing fees range from $5000 to $15,000. • Clinical trial costs can total $200,000. • Translation fees range ~$8000 depending on your documentation. • Timelines for clinical trials in China depend on issues such as subject recruitment

and site selection. Follow-up timeframes usually take no less than six months. • SFDA reviews of Class III devices take from 12 to 18 months. The entire registration

process can take from ~36 months (not including clinical trials).


Tougher SFDA Regulations Coming • Technical File

– Research Report – Risk Management – Design Dossier – Quality Management System

• Clinical trial – All Class III – Some Class II – Exemption strategy will no longer work

• Review Times – SFDA review time changes from 90

days to 180 days – SFDA certificate will be valid for 5

years

• Factory Inspection – Required for all Class III devices


Additional Resources

• Medical Device Consulting Services for China – http://www.emergogroup.com/services/china

• Chinese Medical Device Market Country Report – http://www.emergogroup.com/services/china/china-regulatory-strategy

• Medical Device Clinical Trial Management in China – http://www.emergogroup.com/services/china/clinical-trials-china

• China Legal Agent and After Sales Agent Representation – http://www.emergogroup.com/services/china/legal-after-sales-agent

• Medical Distributor Search and Qualification in China – http://www.emergogroup.com/services/china/medical-distributor-search-china

For more information:

Elisa Maldonado-Holmertz

VP of Business Development EMERGO GROUP

[email protected]

US office telephone: +1.512.327.9997

Or contact our other offices:

http://www.emergogroup.com/contact www.EmergoGroup.com

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http://www.emergogroup.com/services/china/legal-after-sales-agent�

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