MEDICAL DEVICES INDUSTRY

industry also includes higher value-added and technologically advanced products such as ... location for manufacturing operations, such ... care manag...

0 downloads 224 Views 124KB Size
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.

3   

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

5   



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).

6   

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.

 

7