Regulatory Strategies for Medical Device Companies to Succeed in Asia

Regulatory Strategies
for Medical Device
Companies to
Succeed in Asia
Pacific Bridge Medical

2013 White Paper

www.pacificbridgemedical.com

Regulatory Strategies
for Medical Device
Companies to
Succeed in Asia

2013 White Paper

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, translated, resold, hosted, or otherwise distributed by any means without explicit permission.
Disclaimer: the information contained in this report is the opinion of Pacific Bridge Medical, 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 accuracy, currency, or applicability of any of the contents in relation to specific situations and
particular circumstances.

Map of Asia

Copyright © 2013 Pacific Bridge Medical

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3

China Medical Device
Regulations


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4

China: Geography


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5

China: Medical Device Regulatory
Authorities
❖ 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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6

SFDA: Medical Device Department
Department of Medical Device Supervision

Division of
General
Affairs

Direct
Affiliation

Division I
of
Registration

Division II
of
Registration

Division of
Manufacturing
& Distribution
Supervision

Division of
Research &
Reevaluation

Center of Medical Device Evaluation
(CMDE)
Division of Medical Device
Provincial FDA

Indirect
Affiliation

Certified Test Centers in Key Provinces


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7

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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8

New Class II & III that do NOT
require clinical trials Product
Registration Process
Normal Timeline
1. Chinese Specification Drafting

Dossier Preparation &
Specification Drafting

Depends on the Company
and Product

6 Months

Sample Testing

5 working days

Filing to SFDA

90 working days

10 working days

2. Sample Testing

3. SFDA preliminary review &
issues acceptance notice
4. CMDE review

No

5. SFDA final approval

CMDE
Review
Yes

Approximate Total

12-18 months


SFDA Final Approval

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9

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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10

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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11

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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12

Singapore Medical
Device Regulations


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13

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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14

Singapore: Medical Device
Regulatory Authorities
❖ Health Sciences Authority ( HSA )
♦ www.hsa.gov.sg

❖ Centre for Medical Device Regulation ( CMDR )


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15

Medical Device Regulatory
Framework: 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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16

Medical Device Regulatory
FrameworkClassification of General
Medical Devices
Class

Risk Level

Device Examples

A

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


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17

Submission Routes for Class
B, 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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18

Product Registration: Class B, C, and
D Medical Devices (Full Evaluation)
Identify that the product is a
medical device

Pre-Submission Consultation

Pre-submission Consultation

Regulatory Decision

Submission of Device Dossier

Submission of Device Dossier

Screening of Device Dossier

Acceptance of Device Dossier

Evaluation by HSA

Evaluation Decision

Regulatory Decision


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19

HSA Product Registration
Requirements: Medical Device
Dossier 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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20

India Medical
Device Regulations


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21

Map of India


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22

HSA Product Registration
Requirements: Medical Device
Dossier 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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23

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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24

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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25

CDSCOMedical Device &
Diagnostic Division
Organizational Structure
Drugs Controller General of
India

(DCGI)

Deputy Drugs Controller
(India)
Assistant Drugs Controller
(India)

Medical Device Division

Drug Inspectors

Diagnostic Division

Technical Data
Associates


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Drug Inspectors

Technical Data
Associates


26

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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27

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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28

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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29

Proposed Classification for
Medical 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.
Class

Risk Level

Device Examples

A

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


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30

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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31

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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32

Hong Kong Medical
Device Regulations


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33

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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34

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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35

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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36

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 HAtrained 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.


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37

Hong Kong: Regulation Controls
Relating 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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38

Advantages of Registering for
Voluntary 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.


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39

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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40

Risk Classification of Medical Devices

I

II

III

IV

Class I

Class 1 of EU System

Class III

Class 2b of EU System

Class II

Class 2a of EU System

Class IV


Class 3 of EU System

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41

Thank You!
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Bethesda, MD 20814
Click here to contact us for regulatory strategies
for your medical device in Asia.


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42

Regulatory Strategies for Medical Device Companies to Succeed in Asia

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