China: Medical Device Regulations

Pacific Bridge Medical2013 White Paper

China: Medical Device Regulations

www.pacificbridgemedical.com

Pacific Bridge Medical2013 White Paper

China: Medical Device Regulations

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, trans-lated, resold, hosted, or otherwise distributed by any means without explicit permission. Disclaimer: the information contained in this report is the opinion of Pacific Bridge Medi-cal, 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 ac-curacy, currency, or applicability of any of the contents in relation to specific situations and particular circumstances.

Copyright © 2013 Pacific Bridge Medical | www.pacificbridgemedical.com 3

Map of China


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 RegulatoryAuthorities

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 ofGeneralAffairs

Division Iof

Registration

Division IIof

Registration

Division ofManufacturing& DistributionSupervision

Division ofResearch &

Reevaluation

Center of Medical Device Evaluation(CMDE)

Division of Medical DeviceProvincial FDA

Certified Test Centers in Key Provinces

DirectAffiliation

IndirectAffiliation


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 NOTrequire clinical trials ProductRegistration Process

Normal Timeline

1. Chinese Specification Drafting Depends on the Company and Product2. Sample Testing 4 - 5 Months3. SFDA preliminary review &issues acceptance notice 5 working days4. CMDE review 3 months5. SFDA final approval 3 - 5 months

Approximate Total 10 - 13 months

Dossier Preparation & Specification Drafting

Sample Testing

Yes

CMDE Review

No

SFDA Final Approval

Filing to SFDA


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!

Pacific Bridge MedicalConnect with us today.

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www.pacificbridgemedical.com

Click here to contact us for medical device regulatory assistance in China.

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