MEDICAL DEVICES INDUSTRY
In Malaysia, the medical devices industry spans a wide range of industries from rubber and latex, textiles, plastics, machinery and engineering support and electronics.
Under the Eleventh Malaysia Plan (RMK-11), the Government has identified medical devices as one of the high potential growth sectors. The industry has also been identified as one of the growth areas under the Healthcare NKEA under which eight (8) EPPs were announced and targeted to contribute RM17.1 billion in revenue and RM11.4 billion in GNI, as well as generate 86,000 jobs by 2020.
There are approximately more than 200 medical devices manufacturers, mainly the small and medium entreprises (SMEs) manufacturing medical gloves. However, the industry also includes higher value-added and technologically advanced products such as cardiac pacemakers, stents, orthopaedic implantable devices, electromedical, therapeutic and monitoring devices. Major local producers include: − − − − − − − −
Abio Orthopaedics Sdn. Bhd.; Straits Orthopaedics (Mfg) Sdn. Bhd.; Vigilenz Medical Devices Sdn. Bhd.; Granulab (M) Sdn. Bhd.; Hospitech Manufacturing Services Sdn. Bhd.; OSA Technology Sdn. Bhd.; Top Glove Sdn. Bhd.; and Kossan Latex Industries (M) Sdn. Bhd.
Thera are currently more than 30 MNCs producing high value-added medical devices, making Malaysia their offshore location for manufacturing operations, such as Agilent, B. Braun, St. Jude Medical, C.R. Bard, Symmetry Medical, Teleflex, Resmed, Ciba Vision, Kelpac Medical, Ambu, Toshiba Medical Systems and Haemonetics.
List of major local and foreign companies is as below: − Local Companies: Company ABio Orthopaedics Sdn Bhd Straits Orthopaedics (Mfg) Sdn. Bhd. Vigilenz Medical Devices Sdn. Bhd.
Products
Location
Orthopaedic products
Penang
Orthopaedic products
Penang
Sutures & disposable articles for surgeries
Penang.
Granulab (M) Sdn. Bhd.
Bone graft substitutes
Selangor
Hospitech Manufacturing Services Sdn. Bhd.
PVC Catheters, bandages and gauze
Selangor
OSA Technology Sdn. Bhd.
Orthopaedic trauma implants and instrumentation system
Selangor
Company
Products
Location
Top Glove Sdn. Bhd.
Surgical and examination gloves
Selangor
Kossan Latex Industries (M) Sdn. Bhd.
Surgical and examination gloves
Selangor
− Foreign Companies: Company
Products
B.Braun Medical Industries Infusion and transfusion sets, sutures, intravenous cannula, Sdn. Bhd. large volume parenterals, hemodialysis concentrates, peritoneal dialysis solution, bloodlines, surgical instruments, hypodermic needles, spinal needles, AV fistula epidural anaesthesia sets St. Jude Medical Cardiac rhythm management Operations e.g. pacemakers, defibrillators and leads
Location
Germany
Penang
USA
Symmetry Medical Medical sterilising cases, Malaysia Sdn Bhd medical instruments and orthopaedic implants
USA
Ciba Vision Johor Sdn. Contact lenses Bhd. (Novartis Group)
USA
Teleflex Medical Ltd.
Steripack Sdn. Bhd.
Medical
Bard Sdn. Bhd.
Penang
Penang Johor
Catheters, blood pressure bags, blood pressure bulbs, penrose drains.
PVC endotrachael tubes, red rubber trachaeln tubes and nasal cannulae.
Rebreathing bags, Heat and moisture exchanger and filters for breathing system and tracheostomy tubes. Asia Medical device R&D services, medical device packaging, orthopaedic implants Foley catheters and procedural kits 2
Origin
USA
Perak
Ireland
Selangor
USA
Kedah
Company Ambu Sdn. Bhd.
Disposable medical electrodes
Haemonetics Sdn. Bhd. Medipro Bhd.
Malaysia Whole Blood Devices & Apheresis Devices
Location
Denmark
Penang Penang
(M)
Mediquip Sdn. Bhd.
Latex Foley Catheters
Ansell (M) Sdn. Bhd.
Household, examination and surgical gloves
Japan
Selangor
Japan
Selangor
USA
Perlis
Australia
Kedah
List of Associations for Medical Devices Industry as below:
Name of Current President Membership
Address
Contact Detail
Roles
Association Of Malaysian Medical Industries (AMMI) Mr. Hitendra Joshi
Malaysia Medical Device Association (MMDA) Mr. Yong Tuan Heng
62 members
180 members
Level 32 Menara Prestige No. 1 Jalan Pinang 50450 Kuala Lumpur
Suite A-807, Level 8, Block A, Kelana Square No: 17 Jalan SS7/26, 47301 Kelana Jaya, Selangor
T:010 4040 662 F:6032178 4347 Email:
[email protected]
T:03-7804 4468 F:60378054469 Email:
[email protected]
AMMI continue to be the growth base of the medical device industry in Malaysia and consist of three main types of industry players: manufacturers; suppliers of raw materials and services to the medical devices manufacturing companies; and importers and exporters of medical devices, all of whom employ a sizable workforce in their production facilities.
The Malaysia Medical Device Association or commonly known as MMDA has a diversity of members comprising of local manufacturers, local authorised representatives, importers, suppliers, distributors, multi-national corporations and service providers involved in the distribution and sales of medical devices and related healthcare products and equipment within Malaysia.
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Origin
USA
Sdn. Single use hospital theatre surgical gowns and draping system Meditop Corporation (M) Extension tube, scalp vein set, Sdn. Bhd infusion set, I.V. catheters, urinary bag, suction catheters
Mfg.
Products
I.
PROMOTED ACTIVITIES & TARGETED PRODUCTS
Promoted Activities under Promotion Investment Act (1986) -
Targeted products -
II.
General List High Technology List Strategic Project Incentives Reinvestment Allowance Automation Capital Allowance Expenditure (ACA)
Electromedical equipment Cardiovascular devices Orthopaedic devices In-vitro diagnostic products Wound care management products Products from convergence of technology (medical devices/ pharmaceutical/ electronics/ ICT/IoT/ 3D Printing)
POLICIES
Medical Device Act, 2012 -
With the enforcement of the Medical Device Act 2012, all medical devices manufactured, imported or sold in Malaysia are required to be registered with the Medical Device Authority (MDA), a body under the Ministry of Health Malaysia responsible in regulating the medical devices industry.
-
The Medical Devices Regulations 2012 is aimed at protecting patients and other customers from substandard and unregistered medical devices. Medical devices are categorised into A, B, C and D depending on the risk level and intended use.
General Classification System for Medical Devices Class A
-
Risk Level Low Risk
Device Examples 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 Valve, Implantable Defibrillator
The Medical Devices Regulations 2012 is aimed at protecting patients and other customers from substandard and unregistered medical devices. Medical devices are categorised into A, B, C and D depending on the risk level and intended use. 4
III.
TRADE IN MEDICAL DEVICES INDUSTRY Export Year 2013
Total (RM million) RM 11,900
2014
RM 13,400
2015
RM 15,533
2016
RM 15,841
Top 5 Major Export Items 1. Surgical and examination gloves
Total (RM million) 2016 RM 7,882
2. Other Medical Instruments, Apparatus and Appliances
RM 3,802
3. Catheters, syringes, needles and sutures
RM 2,135
4. Electro medical equipment
RM 1,122
5. Ophthalmic lenses, including contact lenses
RM 771
Import Year 2013
Total (RM million) RM 3,417
2014
RM 3,943
2015
RM 4,424
2016
RM 4,544
Top 5 Major Import Items 1. Other Medical Instruments, Apparatus and Appliances
Total (RM million) 2016 RM 2,336
2. Electro medical equipment
RM 563
3. Catheters, syringes, needles and sutures
RM 617
4. Electro medical equipment
RM 540
5. Medical and surgical x-ray apparatus
RM 247
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Total trade for 2016 was valued at RM20.4billion. In terms of trade, exports of medical devices in 2016 amounted to RM15.8 billion, an increase of 2% as compared to RM15.5 billion in 2015. Major exports in 2016 were: − − − − −
surgical and examination gloves (RM7.9 billion); other medical instruments, apparatus and appliances (RM3.8 billion); catheters, syringes, needles and sutures (RM2.1 billion); electro medical equipment (RM1.1billion); and opthalmic lenses, including contact lenses (RM0.8 billion).
Top 5 export destinations in 2016 were the US (RM4.1 billion), Germany (RM1.7 billion), Belgium (RM1.6 billion), Japan (RM1.2 billion), and Singapore (RM1 Billion)
Imports of medical devices in 2016 amounted to RM4.5 billion, an increase of 3% as compared to RM4.4 billion in 2015. Major imports in 2016 were: − − − − −
other Medical Instruments, Apparatus and Appliances (RM2.3 billion). catheters,Syringes,Needles and Sutures (RM0.6 billion); and opthalmic Lenses, Including Contact Lenses (RM0.6 billion); electro medical equipment (RM0.5 billion); and medical and surgical x-ray apparatus (RM0.2 billion)
Top 5 import destinations in 2016 were the US (RM0.9 billion), Singapore (RM0.7 billion), China (RM0.6 billion), Germany (RM0.5 billion), and Japan (RM0.4 billion).
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IV.
INVESTMENT Approved Investment (2013 – 2016) 2013
2014
2015
2016
Total
No of projects
43
42
30
41
156
Employment
18,302
7,300
7,872
7,386
40,860
1,330 (27.7%)
1,225 (54.5%)
1,200 (66.7%)
1,279 (44.6%)
5,034
3,391 (72.3%)
1,000 (45.5%)
603 (33.3%)
1,588 (55.4%)
6,582
4,721
2,225
1,803
2.867
11,616
Domestic Investment (RM mil.) Foreign Investment (RM mil.) Total (RM mil.)
Implemented Projects (2013 - 2015)
No of projects Domestic Investment (RM mil.) Foreign Investment (RM mil.) Total (RM mil.)
2013
2014
2015
31
27
19
3,100
552
479
1,400
543
191
4,500
1,095
670
In 2015, a total of 30 projects with investments orth RM1.8 billion were approved. Of this, 19 projects (RM670 million) have been implemented. While in 2016, a total of 41 projects were approved.
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