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“Growing demand from the healthcare industry to drive the market for sterile medical packaging”
The global market for sterile medical packaging is projected to grow from USD 26.55 billion in 2015 to reach USD 35.07 billion by 2020, at an estimated CAGR of 5.72%. The market for sterile medical packaging is driven by the growing demand from the healthcare industry due to increase in health awareness.

“Need for harmonization between the global standards and regulations in the sterile medical packaging market”
In line with the global applicable standards, each country may have its own specific set of applications and environments in which the product needs to perform. Having multiple standards may create confusion and trade barriers for manufacturers. Hence, in order to avoid this as well as to easily understand and implement packaging requirements, harmonization between the standards is necessary.

“Asia-Pacific projected to grow during the forecast period”
Asia-Pacific is projected to be the fastest-growing region in the sterile medical packaging market in the next five years. However, factors such as longer timelines for approving the medical devices in Australia, red tapism in India, and higher cost for the approval of medical devices make the regulatory framework in the region more complex.

Breakdown of Primaries:
Primary interviews were conducted with a number of industry experts in order to collect data related to different aspects of sterile medical packaging. Estimates reached after analyzing secondary sources were validated through these interviews. Primary sources include professionals such as sterile packaging manufacturers, distributors, and academic professionals. Distribution of primary interviews is as follows:

By Company Type: Tier 1 – 38%, Tier 2 – 38%, and Tier 3 – 24%
By Designation: C-level – 38%, Manager Level – 34%, and Others* – 28%
By Region: North America – 32%, Europe – 28%, Asia-Pacific – 25%, and RoW – 15%

The tier of the companies is defined on the basis of their total revenue, as of 2014: Tier 1: Revenue >USD 500 million, Tier 2: Revenue USD 100 to USD 500 million, and Tier 3: Revenue *Others include sales managers, marketing managers, and product managers.

Reasons to buy the report
The report will help the market leaders/new entrants in this market in the following ways:
1. This report segments the market for sterile medical packaging comprehensively and provides the closest approximations of the revenue numbers for the overall market across different regions.
2. The report helps stakeholders to understand the market and related regulations further providing them information on key market drivers, restraints, challenges, and opportunities.
3. The report helps to understand the regulatory aspects of the sterile medical packaging industry for the top key countries and regions.

Table Of Contents

Regulatory Environment and Impact Analysis- Sterile Packaging Market Standards and Regulations, Regional and National Regulatory Bodies - Market Analysis and Forecast to 2020
TABLE OF CONTENTS

1 INTRODUCTION 15
1.1 OBJECTIVES OF THE STUDY 15
1.2 MARKET DEFINITION 15
1.3 STUDY SCOPE 15
1.3.1 PERIODIZATION CONSIDERED FOR THE STERILE MEDICAL PACKAGING MARKET 15
1.4 CURRENCY CONSIDERED FOR THE STERILE MEDICAL PACKAGING MARKET 15
1.5 UNIT CONSIDERED FOR THE STERILE MEDICAL PACKAGING MARKET 16
1.6 STAKEHOLDERS 16
2 RESEARCH METHODOLOGY 17
2.1 RESEARCH DATA 17
2.1.1 SECONDARY DATA 17
2.1.1.1 Key Data From Secondary Sources 17
2.1.2 PRIMARY DATA 18
2.1.2.1 Key Data From Primary Sources 18
2.1.2.1.1 Breakdown of primaries by company type, designation and region 19
2.2 FACTOR ANALYSIS 19
2.2.1 INTRODUCTION 19
2.2.2 OVERVIEW OF PARENT INDUSTRY 20
2.2.3 DEMAND-SIDE ANALYSIS 20
2.2.3.1 Rising Population 21
2.2.3.1.1 Increase in the middle-class population, 2009-2030 21
2.2.3.2 Increasing Urban population 22
2.2.3.3 Developing Economies: GDP (Purchasing Power Parity) 23
2.2.4 SUPPLY-SIDE ANALYSIS 24
2.2.4.1 Fluctuation in Raw Material Prices 24
2.2.4.2 Increasing Investment in Research and Development to Develop Innovative Technologies 25
2.3 MARKET SIZE ESTIMATION 25
2.4 MARKET BREAKDOWN and DATA TRIANGULATION 27
2.5 RESEARCH ASSUMPTIONS and LIMITATIONS 28
2.5.1 ASSUMPTIONS 28
2.5.2 LIMITATIONS 28

3 EXECUTIVE SUMMARY 29
3.1 INTRODUCTION 29
3.2 REGULATORY SCENARIO 30
3.2.1 REGULATORY FRAMEWORK IN NORTH AMERICA 30
3.2.2 REGULATORY FRAMEWORK IN ASIA-PACIFIC 31
3.2.3 REGULATORY FRAMEWORK IN EUROPE 31
3.2.4 REGULATORY FRAMEWORK IN ROW 31
3.3 MEDICAL DEVICE APPROVAL PROCESS IN KEY COUNTRIES 32
3.4 IMPACT ANALYSIS 38
3.4.1 CASE STUDY: MEDICAL DEVICE RECALL and ITS IMPACT 38
3.4.2 NEED FOR HARMONIZATION OF GLOBAL STANDARDS and REGULATIONS 39
4 MARKET OVERVIEW OF STERILE MEDICAL PACKAGING 40
4.1 INTRODUCTION 40
4.2 EVOLUTION 40
4.3 MARKET DYNAMICS 41
4.3.1 DRIVERS 42
4.3.1.1 Increased Health Awareness 42
4.3.1.2 Growing Demand from Healthcare Industry 43
4.3.1.3 Aging Population 43
4.3.2 RESTRAINTS 44
4.3.2.1 Stringent Regulations 44
4.3.3 OPPORTUNITIES 45
4.3.3.1 New Product Development and Continuous Innovations in Pharmaceuticals 45
4.3.3.2 Developing New Sustainable Packaging Options 45
4.3.4 CHALLENGES 45
4.3.4.1 Maintaining Medical Packaging Integrity 45
4.3.4.2 Rise in Healthcare Cost 46
4.4 STERILE MEDICAL PACKAGE DEVELOPMENT 47
4.5 FUNCTIONS OF A STERILE MEDICAL PACKAGE 48
4.5.1 PROTECTION 48
4.5.2 EASE OF USE 48
4.5.3 IDENTIFICATION 48
4.5.4 PROCESSABILITY 48
4.5.5 SPECIAL APPLICATIONS 48

5 INTERNATIONAL GOVERNING BODIES 49
5.1 INTRODUCTION 49
5.2 AMERICAN SOCIETY FOR TESTING AND MATERIALS (ASTM) 49
5.2.1 ASTM COMMITTEE D10 49
5.2.1.1 D10.13 50
5.2.1.2 D10.19 50
5.2.1.3 D10.27 51
5.2.1.4 D10.32 51
5.2.2 ASTM COMMITTEE F02 52
5.2.2.1 F02.10 52
5.2.2.2 F02.15 53
5.2.2.3 F02.20 54
5.2.2.4 F02.40 55
5.2.2.5 F02.50 55
5.3 INTERNATIONAL ORGANIZATION OF STANDARDIZATION (ISO) 56
5.3.1 DEVELOPING ISO STANDARDS 57
5.3.1.1 Preliminary Stage 58
5.3.1.2 Proposal Stage 58
5.3.1.3 Preparatory Stage 58
5.3.1.4 Committee Stage 58
5.3.1.5 Enquiry Stage 59
5.3.1.6 Approval Stage 59
5.3.1.7 Publication Stage 59
5.3.2 STANDARDS RELATED TO STERILE MEDICAL PACKAGING 59
5.3.2.1 ISO 16775 59
5.3.2.2 ISO 11607 60
5.3.2.2.1 Application 61
5.3.2.2.2 Limitation 61
5.3.2.3 ISO 11607-1 61
5.3.2.4 ISO 11607-2 62
5.4 U.S. FOOD AND DRUG ADMINISTRATION (FDA) 63
5.5 INTERNATIONAL MEDICAL DEVICE REGULATORY FORUM (IMDRF) 65
6 REGULATORY FRAMEWORK FOR STERILE MEDICAL PACKAGING IN NORTH AMERICA 66
6.1 NORTH AMERICA 66
6.2 NORTH AMERICA: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY 66
6.2.1 U.S. 67
6.2.2 KEY GOVERNING BODIES IN THE U.S. 68
6.2.2.1 FDA 68
6.2.2.1.1 Overview 68
6.2.2.1.2 Responsibilities 68
6.2.3 CANADA 69
6.2.4 KEY GOVERNING BODIES IN CANADA 69
6.2.4.1 Health Canada (HC) 69
6.2.4.1.1 Overview 69
6.2.4.1.2 Responsibilities 70
6.2.5 MEXICO 70
6.2.6 KEY GOVERNING BODIES IN MEXICO 70
6.2.6.1 Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) 70
6.2.6.1.1 Overview 70
6.2.6.1.2 Responsibilities 71
7 REGULATORY FRAMEWORK FOR STERILE MEDICAL PACKAGING IN EUROPE 72
7.1 EUROPE 72
7.2 EUROPE: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY 73
7.3 GOVERNING BODIES IN EUROPE 74
7.3.1 EUROPEAN COMMITTEE FOR STANDARDIZATION (CEN) 74
7.3.1.1 Overview 74
7.3.1.2 Standards Developed by CEN 74
7.3.1.2.1 Harmonization of EN 868-1 and ISO 11607 75
7.3.1.2.2 EN 868-2: 2009 75
7.3.1.2.3 EN 868-3:2009 77
7.3.1.2.4 EN 868-4:2009 78
7.3.1.2.5 EN 868-5:2009 80
7.3.1.2.6 EN 868-6:2009 81
7.3.1.2.7 EN 868-7:2009 83
7.3.1.2.8 EN 868-8:2009 84
7.3.1.2.9 EN 868-9:2009 86
7.3.1.2.10 EN 868-10:2009 87
7.3.2 STERILE BARRIER ASSOCIATION (SBA) 89
7.3.2.1 Overview 89
7.3.2.2 SBA Member Categories 89
7.3.2.3 Administering Activities 89
7.4 MEDICAL DEVICE REGULATIONS IN EUROPE 90
7.4.1 INTRODUCTION 90
7.4.2 MEDICAL DEVICE DIRECTIVE (93/42/EEC) 90
7.5 IMPACT OF MEDICAL DEVICE REGULATIONS IN EUROPE 90
7.5.1 CE MARKING- A GATEWAY TO ACCESS EUROPEAN MARKET 90
7.5.2 IMPACT OF HARMONIZATION BETWEEN EN AND ISO 91

7.6 KEY COUNTRIES IN EUROPE 91
7.6.1 GERMANY 91
7.6.2 KEY GOVERNING BODIES IN GERMANY 92
7.6.2.1 Federal Ministry of Health 92
7.6.2.1.1 Overview 92
7.6.2.1.2 Administering activities 92
7.6.2.2 German Institute for Standardization (DIN) 93
7.6.2.2.1 Overview 93
7.6.2.2.2 Organizational structure 93
7.6.2.2.3 Administering activities 93
7.6.3 U.K. 94
7.6.4 KEY GOVERNING BODIES IN THE U.K. 94
7.6.4.1 Medicines and Healthcare products Regulatory Agency (MHRA) 94
7.6.4.1.1 Overview 94
7.6.4.1.2 Responsibilities 95
7.6.4.2 Department of Health (DH) 96
7.6.4.2.1 Overview 96
7.6.4.2.2 Responsibilities 96
7.6.4.3 Association of British Healthcare Industries (ABHI) 97
7.6.4.3.1 Overview 97
7.6.4.3.2 Responsibilities 98
7.6.4.4 The British Standards Institution (BSI) 98
7.6.4.4.1 Overview 98
7.6.4.4.2 Responsibilities 99
7.6.5 FRANCE 99
7.6.6 KEY GOVERNING BODIES IN FRANCE 100
7.6.6.1 National Agency for the Safety of Medicine and Health Products (ANMS) 100
7.6.6.1.1 Overview 100
7.6.6.1.2 Responsibilities 100
7.6.7 ITALY 100
7.6.8 KEY GOVERNING BODIES IN ITALY 101
7.6.8.1 Ministry of Health (MOH) 101
7.6.8.1.1 Overview 101
7.6.8.1.2 Responsibilities 102
7.6.8.2 Italian Medicines Agency 103
7.6.8.2.1 Overview 103
7.6.8.2.2 Responsibilities 103

8 REGULATORY FRAMEWORK FOR STERILE MEDICAL PACKAGING
IN ASIA-PACIFIC 104
8.1 ASIA-PACIFIC 104
8.2 ASIA-PACIFIC: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY 104
8.2.1 CHINA 105
8.2.2 KEY GOVERNING BODIES IN CHINA 106
8.2.2.1 China Food and Drug Administration (CFDA) 106
8.2.2.1.1 Overview 106
8.2.2.1.2 Responsibilities 106
8.2.3 JAPAN 106
8.2.4 KEY GOVERNING BODIES IN JAPAN 107
8.2.4.1 Ministry of Health, Labor and Welfare (MHLW) 107
8.2.4.1.1 Overview 107
8.2.4.1.2 Responsibilities 107
8.2.5 INDIA 107
8.2.6 KEY GOVERNING BODIES IN INDIA 108
8.2.6.1 Central Drugs Standard Control Organization (CDSCO) 108
8.2.6.1.1 Overview 108
8.2.6.1.2 Responsibilities 108
8.2.7 AUSTRALIA 109
8.2.8 KEY GOVERNING BODIES IN AUSTRALIA 109
8.2.8.1 Therapeutic Goods Administration (TGA) 109
8.2.8.1.1 Overview 109
8.2.8.1.2 Responsibilities 110
9 REGULATORY FRAMEWORK FOR STERILE MEDICAL PACKAGING IN ROW 111
9.1 ROW 111
9.2 ROW: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY 111
9.2.1 BRAZIL 112
9.2.2 KEY GOVERNING BODIES IN BRAZIL 113
9.2.2.1 National Health Surveillance Agency (ANVISA) 113
9.2.2.1.1 Overview 113
9.2.2.1.2 Responsibilities 113
9.2.3 ARGENTINA 113
9.2.4 KEY GOVERNING BODIES IN ARGENTINA 114
9.2.4.1 National Administration of Drugs, Foodstuffs, and Medical Technology (ANMAT) 114
9.2.4.1.1 Overview 114
9.2.4.1.2 Responsibilities 114
9.2.5 SOUTH AFRICA 114

9.2.6 KEY GOVERNING BODIES IN SOUTH AFRICA 115
9.2.6.1 Medicines Control Council (MCC) 115
9.2.6.1.1 Overview 115
9.2.6.1.2 Responsibilities 115
10 APPENDIX 116
10.1 INSIGHTS OF INDUSTRY EXPERTS 116
10.2 DISCUSSION GUIDE 117
10.3 INTRODUCING RT: REAL TIME MARKET INTELLIGENCE 119
10.4 AVAILABLE CUSTOMIZATIONS 120
10.5 RELATED REPORTS 121


LIST OF TABLES

TABLE 1 ASIA-PACIFIC: URBANIZATION PROSPECTS 23
TABLE 2 TECHNICAL SUBCOMMITTEES 49
TABLE 3 TECHNICAL SUBCOMMITTEES 52
TABLE 4 ANNEX 59
TABLE 5 ISO 11607-1 61
TABLE 6 ISO 11607-2 63
TABLE 7 NORTH AMERICA: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY, 2013-2020 (USD MILLION) 66
TABLE 8 NORTH AMERICA: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY, 2013-2020 (MILLION UNITS) 67
TABLE 9 EUROPE: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY,
2013-2020 (USD MILLION) 73
TABLE 10 EUROPE: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY,
2013-2020 (MILLION UNITS) 73
TABLE 11 EN 868-2:2009 76
TABLE 12 IMPLEMENTATION OF EN 868-2:2009 IN EUROPEAN COUNTRIES 76
TABLE 13 EN 868-3:2009 77
TABLE 14 IMPLEMENTATION OF EN 868-3:2009 IN EUROPEAN COUNTRIES 77
TABLE 15 EN 868-4:2009 78
TABLE 16 IMPLEMENTATION OF EN 868-4:2009 IN EUROPEAN COUNTRIES 79
TABLE 17 EN 868-5:2009 80
TABLE 18 IMPLEMENTATION OF EN 868-5:2009 IN EUROPEAN COUNTRIES 80
TABLE 19 EN 868-6:2009 81
TABLE 20 IMPLEMENTATION OF EN 868-6:2009 IN EUROPEAN COUNTRIES 82
TABLE 21 EN 868-7:2009 83
TABLE 22 IMPLEMENTATION OF EN 868-7:2009 IN EUROPEAN COUNTRIES 83
TABLE 23 EN 868-8:2009 84
TABLE 24 IMPLEMENTATION OF EN 868-8:2009 IN EUROPEAN COUNTRIES 85
TABLE 25 EN 868-9:2009 86
TABLE 26 IMPLEMENTATION OF EN 868-9:2009 IN EUROPEAN COUNTRIES 86
TABLE 27 EN 868-10:2009 87
TABLE 28 IMPLEMENTATION OF EN 868-10:2009 IN EUROPEAN COUNTRIES 87
TABLE 29 STANDARDS PUBLISHED BY NA 063-04-04 AA 93
TABLE 30 ASIA-PACIFIC: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY,
2013-2020 (USD MILLION) 104
TABLE 31 ASIA-PACIFIC: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY,
2013-2020 (MILLION UNITS) 105
TABLE 32 ROW: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY,
2013-2020 (USD MILLION) 111
TABLE 33 ROW: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY,
2013-2020 (MILLION UNITS) 112


LIST OF FIGURES

FIGURE 1 GLOBAL POPULATION PROJECTED TO REACH ?9.5 BILLION BY 2050 21
FIGURE 2 MIDDLE-CLASS POPULATION, 2009-2030 22
FIGURE 3 PROJECTED GDP PER CAPITA, BY COUNTRY 24
FIGURE 4 FLUCTUATIONS IN PRICE OF NATURAL GAS FROM 2008 TO 2015 25
FIGURE 5 MARKET SIZE ESTIMATION METHODOLOGY: BOTTOM-UP APPROACH 26
FIGURE 6 MARKET SIZE ESTIMATION METHODOLOGY: TOP-DOWN APPROACH 26
FIGURE 7 NORTH AMERICA DOMINATED THE STERILE MEDICAL PACKAGING MARKET IN 2014 30
FIGURE 8 MEDICAL DEVICES APPROVAL PROCESS IN EUROPE 32
FIGURE 9 MEDICAL DEVICES APPROVAL PROCESS IN CHINA 33
FIGURE 10 MEDICAL DEVICES APPROVAL PROCESS IN AUSTRALIA 34
FIGURE 11 PROCESS TO SUPPLY IMPORTED MEDICAL DEVICES IN AUSTRALIA 35
FIGURE 12 MEDICAL DEVICES APPROVAL PROCESS IN JAPAN 36
FIGURE 13 MEDICAL DEVICES APPROVAL PROCESS IN BRAZIL 37
FIGURE 14 REASONS FOR MEDICAL DEVICE PRODUCT RECALLS 38
FIGURE 15 EVOLUTION OF STERILE MEDICAL PACKAGING 41
FIGURE 16 STERILE MEDICAL PACKAGING MARKET DYNAMICS 42
FIGURE 17 REVENUE GENERATED BY PHARMACEUTICALS AND MEDICINES IN THE U.S. 43
FIGURE 18 GLOBAL AGING POPULATION, 2010-2015 44
FIGURE 19 NUMBER OF RECALLS, 2010-2012 46
FIGURE 20 SPENDING ON RETAIL PRESCRIPTION DRUGS 47
FIGURE 21 ISO STANDARDS PORTFOLIO, BY SECTOR, 2014 56
FIGURE 22 DEVELOPMENT PROCESS FOR ISO STANDARDS 57
FIGURE 23 MEDICAL DEVICE CIRCLE 62
FIGURE 24 MEDICAL DEVICES APPROVAL PROCESS BY FDA 64
FIGURE 25 FDA: ORGANIZATION CHART 68
FIGURE 26 HEALTH CANADA: ORGANIZATION CHART 69
FIGURE 27 FEDERAL COMMISSION FOR THE PROTECTION AGAINST SANITARY RISK: ORGANIZATION STRUCTURE 71
FIGURE 28 FEDERAL MINISTRY OF HEALTH: ORGANIZATION CHART 92
FIGURE 29 MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY: ORGANIZATIONAL STRUCTURE 95
FIGURE 30 DEPARTMENT OF HEALTH: ORGANIZATION CHART 96
FIGURE 31 ASSOCIATION OF BRITISH HEALTHCARE INDUSTRIES: ORGANIZATION STRUCTURE 97
FIGURE 32 THE BRITISH STANDARDS INSTITUTION: ORGANIZATION STRUCTURE 98
FIGURE 33 NATIONAL AGENCY FOR THE SAFETY OF MEDICINE AND HEALTH PRODUCTS: ORGANIZATION CHART 100
FIGURE 34 MINISTRY OF HEALTH: ORGANIZATION STRUCTURE 102
FIGURE 35 ITALIAN MEDICINES AGENCY: ORGANIZATION CHART 103

FIGURE 36 MINISTRY OF HEALTH, LABOR AND WELFARE: ORGANIZATION STRUCTURE 107
FIGURE 37 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION: ORGANIZATION STRUCTURE 108
FIGURE 38 THERAPEUTIC GOODS ADMINISTRATION: ORGANIZATION STRUCTURE 110
FIGURE 39 MEDICINES CONTROL COUNCIL: ORGANIZATION STRUCTURE 115

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