regulatory strategies for medical device companies to succeed in asia

Pacific Bridge Medical2013 White Paper

Regulatory Strategies for Medical Device Companies to Succeed in Asia

www.pacificbridgemedical.com

Pacific Bridge Medical2013 White Paper

Regulatory Strategies for Medical Device Companies to Succeed in Asia

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 Asia


China Medical Device Regulations


China: Geography


China: Medical Device RegulatoryAuthorities

State Food & Drug Administration (SDFA) 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


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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New Class II & III that do NOTrequire clinical trials ProductRegistration Process

Normal Timeline

1. Chinese Specification Drafting Depends on the Company and Product2. Sample Testing 6 Months3. SFDA preliminary review &issues acceptance notice 5 working days4. CMDE review 90 working days5. SFDA final approval 10 working days

Approximate Total 12-18 months

Dossier Preparation & Specification Drafting

Sample Testing

Yes

CMDE Review

No

SFDA Final Approval

Filing to SFDA


Product Standard and Type Testing

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.

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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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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Clinical Trials

Clinical trial is required for medical devices when:

New Class II & III medical device, which has not been approved anywhere in the world.

Some Class III implant products. It is the first medical device product of the foreign company applying for registration in China, and this product has already been approved in the foreign country.

Regulations for more clinical trials in China may be coming

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Singapore MedicalDevice Regulations


Singapore: Demographics

Population: 4.7 million

Life expectancy: 82 years

Major ethnic groups

77% Chinese

14% Malay

8% Indian

Language

Four official languages: Mandarin Chinese, English, Malay, and Tamil

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Singapore: Medical DeviceRegulatory Authorities

Health Sciences Authority ( HSA )

www.hsa.gov.sg

Centre for Medical Device Regulation ( CMDR )

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Medical Device RegulatoryFramework: Overview

Registration of Products

Medical devices must be registered with HSA before it can be supplied in Singapore

Supply/Distribution Chain Control Post-marketing activity

Advertising & promotion

Recalls

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Medical Device RegulatoryFrameworkClassification of General Medical Devices

Class Risk Level Device ExamplesA Low Risk Surgical retractors /

tongue depressors

B Low-moderate Risk Hypodermic Needles / suction equipment

C Moderate-high Risk Lung ventilator / bone fixation plate

D High Risk Heart valves / implantable defibrillator


Submission Routes for ClassB, C, and D Medical Devices

Abridged Submission

ONLY for medical device already registered or approved in two of the following reference agencies: USA, Japan, EU, Canada, Australia Full Evaluation

For all products not approved in two of the reference agencies

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Product Registration: Class B, C, and D Medical Devices (Full Evaluation)

Identify that the product is a medical device

Pre-submission Consultation

Submission of Device Dossier

Screening of Device Dossier

Acceptance of Device Dossier

Evaluation by HSA

Evaluation Decision

Regulatory Decision

Pre-Submission Consultation

Regulatory Decision

Submission of Device Dossier


HSA Product RegistrationRequirements: Medical DeviceDossier Preparation

Medical device product registration in Singapore uses the Association of Southeast Asian Nations (ASEAN) Common Submission Dossier Template (CSDT)

The CSDT dossier must:

Be prepared in English

Have as Annexes copies of labeling, Certificates and Reports that are referenced within the CSDT submission

Be signed off by the Product Owner for all Reports

Sample components of the CSDT device dossier:

Description of the medical device and its features

Intended use, and indications

Instruction of use

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India MedicalDevice Regulations


Map of India


HSA Product RegistrationRequirements: Medical DeviceDossier Preparation

There is no single national health insurance system; most people have no insurance.

What exists is a number of schemes of free/ concessional treatments and insurance, mainly for hospitalization.

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India’s Medical Device Market

Market size : US$3.5 billion

Per capita spending : US$2.50

Imports : 70%

Recent annual growth rate : 12%

Projected growth rate up to 2015 : 12 – 16%

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India Medical Device Regulation

In India, the manufacturing, import, sale and distribution of medical devices are regulated under India’s Drugs & Cosmetic Act and Rules (DCA).

Drug Controller General of India (DCGI):

DCGI is the key official in the Central Drug Standards Control Organization (CDSCO)

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CDSCOMedical Device &Diagnostic Division

Drugs Controller General of India (DCGI)

Deputy Drugs Controller(India)

Assistant Drugs Controller(India)

Medical Device Division

Organizational Structure

Diagnostic Division

Drug Inspectors Technical DataAssociates Drug Inspectors Technical Data

Associates


India Medical Device Regulators

Functions of DCGI:

Approval of manufacturing certain drugs (vaccines, large volume parenterals, blood products, r-DNA derived), specific medical devices and new drugs.

Currently, only 40-50 medical devices require registration

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Product Registration Process

Companies must register regulated medical devices with the CDSCO before they can be introduced into the Indian market.

The product registration of medical devices can take between 6 and 18 months if there are no clinical trials.

For registration of new medical devices, prior approval from the DCGI is required before the registration can be applied for.

After receipt of application with fees, evaluation begins.

DCGI may require clinical testing in India or abroad.

DCGI may visit the manufacturing premises during the process

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Working Towards an Official Definition for Medical Devices

The CDSCO released a draft document, Schedule M-III, which contains proposed official definitions for various types of medical devices in India.

A four level medical device risk classification scheme (Classes A (lowest risk) to D (highest risk)) was also outlined in the new proposed draft Schedule M-III.

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Proposed Classification forMedical Devices

The draft Schedule M-III also has a risk classification for medical devices, according to their intended use.

The risk classification is divided into Classes A,B, C and D.

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Class Risk Level Device ExamplesA Low Risk Thermometers / tongue

depressors

B Low-moderate Risk Hypodermic Needles / suction equipment

C Moderate-high Risk Lung ventilator / bone fixation plate

D High Risk Heart valves / implantable defibrillator


Proposed Medical Devices Regulation Bill (MDRB)

If enacted, the Medical Device Regulation Act (2006) will govern all medical devices throughout India.

If enacted, the Act will establish the MDRA as the regulatory and enforcement body for medical devices.

The MDRA is expected to be headquartered in New Delhi. There may also be other regional offices established in India.

The CEO of the MDRA and other members of the organization shall be appointed by the Central Government.

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Obtaining Import License

The importer can apply for an import license from the DCGI.

The following documents are required for submission for Import License (Form 10) of medical devices in India:

Covering Letter

Authorization Letter

Completed Form 8 and Form 9

Wholesale License

Additional Documents Required

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Hong Kong MedicalDevice Regulations


Some Facts about Hong Kong

Located at China’s south coast at Pearl River Delta

Area of 1,104 km2

Consisted of Hong Kong Island, Kowloon Peninsula and the New Territories

Population at end 2010 is 7.1 million

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Department of Health (DH)

Community Health and health policies/strategies such as SARS, Bird Flu, Scarlet Fever and Legionnaires Disease controls

Community health program, vaccine schemes and education

The Regulator for pharmaceuticals and drugs, radioactive substances and medical devices

Licensing for medical professionals, Chinese herbal doctors

Licensing for 12 private hospitals

Consists of

Centre for Health Protection

Pharmaceuticals and Drug Control Office

Radiation Health Unit

Medical Device Control Office

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Hospital Authority (HA)

Consists of 7 Clusters: HK East Cluster, HK West Cluster, Kowloon East Cluster, Kowloon Central Cluster, Kowloon West Cluster, New Territories East Cluster and New Territories West Cluster

Major Acute Hospitals:

1. Pamela Youde Nethersole Eastern Hospital (PYNEH)

2. Queen Mary Hospital (QMH)

3. Queen Elizabeth Hospital (QEH)

4. Princess Margaret Hospital (PMH)

5. United Christian Hospital (UCH)

6. Prince of Wales Hospital (PWH)

7. Tuen Mun Hospital (TMH)

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What’s More – It’s Business !!

(5) Major procurement in HK comes from Hospital Authority. They are already referring to the voluntary list as a preference for procurement for capital equipment and major purchases of medical equipment and device systems.

(6) Majority of Medical practitioners are HA-trained and hence early application in HA will facilitate future market growth.

(7) Private hospitals in HK all make reference to HA procurement practices.

(8) Mainland China purchases make strong reference to HK registered and listed products.

(9) Hong Kong is a major leader in Asia Harmonization Working Party (AHWP) and a number of Asian countries will make reference to products being registered in HK.


Hong Kong: Regulation ControlsRelating to Medical Devices

Currently, there is no specific legislation to regulate the importation or sale of medical devices in Hong Kong except those containing pharmaceutical products or emitting ionizing radiation

Voluntary Medical Device Administrative Control System (MDACS)

Pharmaceutical and Drugs Control Office

Radiation Health Unit

Proprietary Chinese Medicine or Chinese Herbs

Health food and nutrition supplements

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Advantages of Registering forVoluntary Listing

(1) Manufacturers can make device registration while the product sales to HK market are not affected. No time is lost in the process.

(2) According to DH advice, products registered under the voluntary system will be transferred direct to the regulation list without another dossier submission.


Classification of Medical Devices – Some Definitions

Active medical device

Invasive medical device

Body orifice

Active implantable medical device

Transient, short-term and long-term use

Standalone software(Ref Section 2 of GN-00)

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Risk Classification of Medical Devices

I II III IV

Class I Class 1 of EU SystemClass II Class 2a of EU SystemClass III Class 2b of EU SystemClass IV Class 3 of EU System


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