product registration and regulatory issues

Product Registration and Regulatory UpdatesDon Chen, MBA

CMDA North American Liaison Office

Agenda

Regulatory Environment SFDA Medical Device Registration SFDA Health Food Registration Regulatory Updates Implications for Manufacturers

Regulatory Environment

State Food & Drug Administration (SFDA)• Became part of MOH since Mar 2008

• National regulatory authority of drug and medical device

• In charge of comprehensive supervision on food safety management

General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ)• Drafts rules and regulations on certification and

accreditation, safety and quality licensing, hygiene registration and qualification assessment

• Conducts mandatory safety registration, certification and inspection for certain devices (CCC mark)

SFDA

All imported medical products must be registered with SFDA prior to selling in China

Products made outside China need to go to central SFDA for approval

Registration is valid for 4 years Registration cannot be transferred

AQSIQ

7 categories of MD requires CCC mark• Medical diagnostic X-Ray Equipment

• Haemodialysis Equipment

• Hollow Fiber Dialysers

• Extra-Corporeal blood circuit for blood purification equipment

• Electrocardiographs

• Implantable cardio pacemakers

• Artificial heart lung machine

Enforces safety and quality standards of medicines and health products

SFDA Registration

Required documentation• SFDA registration form

• Legal production qualification (FDA registration)

• Business license of Chinese agent, who must be located in China, have a valid business license and a letter of commission from the manufacture

• Marketing approval from government of country of origin

• Product Standard

• Operation Manual

SFDA Registration, Cont.

Required documentation • Test report issued by SFDA-certified test center

• Clinical trail report

• Quality Guarantee letter

• Letter of authorization to agent undertaking the registration

• Post-sales authorization

• Self-guarantee declaration

SFDA Registration, Cont.

Medical device classification• Class I: low risk, considered safety, general control

safety and effectiveness can be ensured through routine administration

• Class II: middle risk, relative safety, special control further control is required to ensure their safety and effectiveness

• Class III: high risk, highly special control 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

Skin,Cavityand Tract

TraumaTissue

Blood CirculationCentral Circulation

Skin,Cavityand Tract

TraumaTissue

Blood CirculationCentral Circulation

Skin,Cavityand Tract

TraumaTissue

Blood CirculationCentral Circulation

Device for transportationand storage ofpharmaceutical liquid

2 2 3 2 2 3 2 3 3

Device for alternation ofblood and body fluid / / 3 / / 3 / / 3

Device for medical dressing 1 2 2 1 2 2 / / /Surgical instrument(inserted) 1 2 3 2 2 3 2 3 3

Reusable surgicalinstrument 1 1 2 / / / / / /

Disposable aseptic surgicaldevice 1 2 3 2 3 3 2 3 3

Implantables / / / / / / 3 3 3Device for contraceptionand birth control 2 2 3 2 3 3 3 3 3

Device for sterilization andcleaning 2 2 2 2 2 2 2 2 2

Other contacting passivedevice 1 2 3 2 2 3 2 3 3

Device for Treatmentthrough energyDevice for diagnosticmonitoringDevice for body fluidtransportation

Device for ionized radiation

Other general active device

2 3

3

2 2 3

2 2

SFDA Medical Devices ClassificationContracting or inserted Device

Temporary Use Short-term use Long term use

2 /

Form of Operation / Typeof device

3

Pas

sive

Dev

ice

Act

ive

Dev

ice

2

3

2 3

SFDA Registration, Cont.

Registration timeline• Class I: 5-6 months

• Class II & III without clinical: 7-8 months

– Marketed in country of origin

– Manufacture is ISO 9000-certified

– Product modification does not affect safety and efficiency

– Non-implants, no radioactive sources

– Would not cause serious injury or death to patient and operator

• Class II & III with clinical: 12-14 months

Dossier Preparation& Spec Drafting

Sample

testing

Filling

Evaluation Center Review

Clinical Trial Final Approval

Class 1 products

Clinical trial not required

No

Yes

2-3 Months

90 working days

1 month

SFDA Registration, Cont.

Health Food Registration

Health food is defined as food that has specified health functions, suitable to be taken by specified group(s) of people, and for the regulation of the functional states of the human body and is not used for the treatment of diseases.

The category includes vitamin and mineral supplements that may not be used for the purpose of disease treatment.

All health food sold within China must be approved and registered with the SFDA, which will assess and examine the security, effectiveness, quality control and labeling of products.

Health Food Registration

27 categories of health functions claims are approved by the SFDA

• Enhancing immune function, Improving sleep, Improving endurance during anoxia, Assisting protection against irradiation, Increasing bone density

• Improving tired eyesight, Eliminating acne, Eliminating yellow-brown spot, Improving skin moisture, Improving skin oil content, Improving constipation, Assisting protection against chemical liver injury

• Assisting blood lipids reduction , Assisting blood sugar reduction, Antioxidation, Assisting memory improvement, Facilitating lead excretion, Moistening and cleaning throat, Assisting blood pressure reduction, Increasing milk secretion, Improving growth and development, Improving nutritional anemia, Regulating intestinal micro flora, Facilitating digestion,

• Alleviating Physical Fatigue, Controlling obesity

Health Food Registration

Required Documents• Health food registration application form.

• A copy of legal registration certificate of applicants.

• Product’s Chinese name approval notification

• Letter of guarantee stating no infringement of preparatory rights

• Copy of trade registration certificate

• Product R&D Report

• Product formula and formula basis, and the origin and usage basis of raw and supplementary materials

• Effective ingredients/ representative ingredients, contents, and testing methods for effective ingredients / representative ingredients

• Diagram of productive techniques, detailed explanation (including original and translated version) and related research materials

• Product quality standards (corporation standards, including original and translated version) and its compiling explanation, and quality standards of raw and supplementary materials.

Health Food Registration

Required Documents• The category, name, quality standards, and selective basis of

packing materials that in contact with products.

• Test report issued by accredited organizations

• Sample product label and usage instructions

• Legal production qualification issued by country of origin

• Notarized letter of authorization to Chinese agent and copy of its business license or Registration of Rep. Office of Foreign Company

• Marketing approval showing products has been sold in country of origin for more than 1 year

• Relevant standards of producing country (area) or international

• Samples of package, label, directions used in original country, and its Chinese version

• Other information helpful for evaluation• 2 pieces of unopened samples

Health Food Registration Process

SFDA Updates More transparent and streamlined registration

process• Registration requirements and procedures available

at www.sfda.gov.cn• Online inquiry of application status • Reduced redundancies between SFDA and AQSIQ:

– 10 SDFA national testing centers are accredited by AQSIQ

– SFDA and AQSIQ agreed to use the same report format

• Re-registration gets easier Improved efficiency of medical device testing

• Testing centers perform testing on multiple device types

• More than 20 provincial level testing centers opened• Implemented a comprehensive training program

SFDA Updates

MD Adverse Event (AE) Monitoring and Re-evaluation• National ADR center received 12,374 AE

reports in 2007• Imposes mandatory AE monitoring obligations

– Manufactures, distributors and medical institutions must set up AE monitoring systems: record-keeping, tracking (class II & III)

– Standard and annual (class II & III) AE report filing– Reporting AE discovered outside China

• Control measures by manufactures and SFDA actions

• Use of AE Reports– Enhance regulation and Administration, may not be

used to initiate a lawsuit or medical dispute

SFDA Updates

Product Re-evaluation • Establish re-evaluation indicators, methods and procedures• Initiate when associated safety risks discovered• SDFA will start re-evaluation if caused serious injury or

death• Revision of specifications or revocation of certification

New regulations on medical device quality system management

• “Criterion for Medical Device Quality System Management” outlines general requirements for medical device quality system management, covering issues such as design, production, installation, and sales.

• Integrates the ISO 13485 standard and the U.S. FDA quality system inspection technique along with certain requirements specific to China

Implication for manufacturers

Working with a in-country regulatory representative: Independent or distributor• Experienced in regulatory compliance

• Well-established and maintained relationship with the SFDA to ensure Effective and efficient communication

Appointment of legal agent• Required for a foreign medical device manufacturer

that does not have an office in China

• The agent needs to act as a liaison between the drug administration authorities and the foreign manufacturer, and is responsible for reporting adverse incidents and recalling medical devices with potential safety problem

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