상품DB/말레이시아 의료기기 시장동향(2013.1)/내과용ㆍ외과용ㆍ치과용ㆍ수의용 기기[신티그래픽(scintigraphic)식 진단기기ㆍ그 밖의 전기식 의료기기와 시력

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제목

말레이시아 의료기기 시장동향(2013.1)

게시일

2015-11-25

국가

말레이시아

작성자

오새봄(쿠알라룸푸르무역관)

품목

내과용ㆍ외과용ㆍ치과용ㆍ수의용 기기[신티그래픽(scintigraphic)식 진단기기ㆍ그 밖의 전기식 의료기기와 시력 검사기기를 포함한다]

품목코드

9018

작성일자: 2013.1.2

작성자: 쿠알라룸푸르 무역관 박건원 (gunwony@kotra.or.kr)

1. Market Overview

 ○ The medical device market, a promising component of the healthcare industry, range from relatively homogeneous, commodity-type items, such as tongue depressors, syringes and other general hospital supplies, to more advanced products, including cardiac pacemakers, and stents; electromedical, therapeutic, monitoring devices and apparatus; in vitro diagnostics; implantable orthopedic and prosthetic devices and appliances.

 ○ Malaysia’s medical devices industry is now undergoing a transformation in line with the government’s plan to make it among the key catalyst for the country’s economic growth.

 ○ Placed under the health sector which is among the 12 National Key Economic Areas(NKEAs), it has been earmarked as a priority sector for promotion and further development.

 ○ Generally, the Malaysian medical devices industry consists of three main types of industry players:

  - Manufacturers

  - Suppliers of raw materials and services to the medical device manufacturing companies

  - Importers and exporters of medical devices

 ○ The Medical Device Industry(MDI) is not homogeneous. In fact, it is a not really an industry at all but a number of research, development and manufacturing industries all involved in various activities that support human health care. It spans an extremely wide range of industries from rubber and latex, textiles, machinery and engineering support and electronics.

 ○ The key products that comprise the MDI include surgical appliances and supplies, surgical and medical instruments, electro-medical equipment, in-vitro diagnostics(IVD) substances, irradiation apparatus, dental and ophthalmic goods.

 ○ Within Malaysia, the MDI includes firms producing basic hospital supplies such as gloves and bandages, others producing orthopedic devices and yet others involved in the development and manufacture of extremely complex instruments such as defribillators, magnetic resonance imaging(MRI) equipment and radiation therapy devices.

 ○ In addition, there are firms that manufacture incubators for new-born babies, dialysis machines, hearing devices, dental implants and many more aids used for the improvement of human health.

 ○ Finally, there are diagnostic companies that discover and produce tests and kits to discover and analyze illnesses.

 ○ One of the interesting aspects of the medical device group of industries is that they require close linkages with other industries and are thus very likely to succeed in areas where clusters of upstream and downstream firms are present.

 ○ And it is exactly this aspect of the MDIs that, combined with the professionalism and expertise of many of the mid-tier companies, will allow them to move up the value chain and along the value chain in other industries such as aeronautics, photography, precision machinery and electronics.

 ○ The importance and size of Malaysian exports in this sector are driven by three main factors:

  - The size and growth of the rubber gloves and plastic product (tubing, valves and etc.) industry;

  - The emergence of Malaysia as a component importer, specialized assembly and export center; and most importantly,

  - The growth of mid-sized Malaysian companies that are manufacturing increasingly complex equipment that is used to produce sophisticated medical devices or products, such as for example, optics components and ‘finished’ orthopedic devices

 ○ Association of Malaysian Medical Industries(AMMI) identifies ‘ancillary’ industries to the MDI:

  - Rubber – gloves, catherers, condoms;

  - Steel – hypodermic needles, surgical instruments implants;

  - Plastic – intravenous(IV) sets, syringes;

  - Electronic – pacemakers, electrocardiogram(ECG) machines;

  - Textile – surgical gowns, drapes, covers;

  - Packaging – procedural kits; and

  - Food - sutures

 ○ These industries are quite diverse and provide the MDIs with the possibility of creating clusters. However, most of the products that feed from the industries above into the MDIs are rather low-technology such as raw latex for the rubber gloves and catherer producers, not particularly high grade steel for surgical instruments and basic textiles for surgical gowns or covers.

 ○ Malaysia, being globally the 20th largest export nation of the world, is a rather interesting production site.

 ○ The main reasons for this are the low operational costs, including land, electricity, water, telephone and wages/ salaries. These factors have attracted a number of small and medium sized, as well as larger corporations to come to Malaysia.

 ○ Due to its vast rubber resources, Malaysia and Thailand have developed to become the largest manufacturer of condoms.

 ○ The medical devices industry in Malaysia is dominated by companies engaged in the production of medical globes and other medical disposable products.

 ○ Malaysia continued to maintain its leading position in the world’s production of medical gloves (for doctors, surgeons) and rubber catherers, supplying 80 per cent of the world market for catherers and 60 per cent for rubber gloves.

 ○ Currently, there are more than 190 medical devices manufacturers in Malaysia, include around small to large players(manufacturing, distribution, sales).

 ○ The majority of Malaysian owned companies focus on the production of surgical and examination gloves such as Top Glove, WRP Asia Pacific, Dispomed, Supermax and Terang Nusa. Medical glove manufacturers have also diversified into higher quality and specialty gloves, such as low protein, powder-free medical gloves.

 ○ Some major domestic companies operating in Malaysia:

 ○ However, more companies are moving into the manufacture of products made from plastics, silicone and metal alloys. There is tremendous scope for investors to move into the manufacture and R&D of other medical devices such as cardiovascular, wound care, contact lenses, dialysers, orthopaedic products, transplant and medical imaging equipment, patient monitoring systems, electrocardiography equipment, blood flow measurement equipment and dialysis equipment.

 ○ The manufacturers in Malaysia include subsidiaries of large international companies which make high-valued products such as orthopedic devices, surgical instruments and radiographic equipment.

 ○ B.Braun Melsungen AG for example manufactures medical instruments with more than 4000 employees in Penang. Moreover, B-Braun is also investing about RM500 million to expand its research and development and manufacturing facilities at its plant in Bayan Lepas by engaging in nano-technology, information technology and digitalization to improve its medical products.

 ○ Other foreign companies with manufacturing facilities in the country include Ansell Ltd., CR Bard Inc., Rusch Inc., Covidient Ltd.(formerly known as Tyco Healthcare International Ltd.) and Ambu Inc. Many of these companies continue to expand within Malaysia, such as B.Braun Melsungen AG and Rusch Inc. Recent entries into local manufacture in Malaysia include St. Jude Medical(pacemakers) and Jabil Green Point(continuous monitoring devices).

 ○ Most medical products manufactured in Malaysia are self-regulated and conform to internationally recognized quality standards such as the Food and Drug Administration(United States of America), Department of Health(United Kingdom) and Bundesgesundheitsamt(Germany).

 ○ There is also a growing network of suppliers conforming to world class standards that support the country’s medical device industry. Their services include:

  - EtO and gamma sterilization

  - sterile medical packaging

  - medical compounds

  - contract moulding and assembly

  - tool and die making

  - clean room engineering

  - machining and engineering

 ○ The government encourages manufacturers to produce medical equipment locally. They have attempted in recent years to encourage domestic manufacturers to expand production into more technologically advanced products and develop services such as Information and Communications Technology and other support related services. This has been detailed in the Third Industrial Master Plan 2006~2020.

 ○ Incentives are also given to foreign company to invest in the medical sector.

 ○ There are also opportunities for foreign companies to go into joint ventures.

2. Market Trend

 ○ The Malaysian Investment Development Authority(MIDA) is upbeat on the strong growth prospects for medical devices, given the growing regional demand for medical products.

 ○ According to the Health Ministry, Malaysia’s medical devices industry was valued at about RM3.5 billion in 2011 and is expected to reach RM5.3 billion by 2015.

 ○ This seems likely given that the global medical device industry is valued at US$320 billion(RM977.6 billion), which represents 25 per cent of the overall healthcare market.

 ○ Based on a comment by Simranjit Singh, Director, Healthcare Practice, Frost & Sullivan, the medical device industry is climbing steadily at a CAGR of 9.3% from 2009 to 2012.

 ○ The growth will be fuelled by an ageing population, increased access to healthcare, especially in the Asia Pacific, changes in lifestyles and a shifting trend towards health tourism.

 ○ By 2020, it is set to contribute RM11.4 billion to the country’s revenue and create 86,000 jobs.

 ○ In terms of investment, the industry recorded RM172 million in the first nine months of this year(2012). Although the investment value is small compared to other sectors, the Government is looking from the point of view of adding value.

 ○ Increasing government healthcare spending, greater health awareness and the demand for higher standards of living are driving Malaysia’s demand for medical devices.

 ○ An increased demand for safety, accuracy, efficiency and cost from healthcare service providers will consequently also drive the silver industry devices, whilst the convergence of devices and pharma products will be a trend more commonly witnessed especially so in drug delivery. These factors will drive medical device manufacturers to increase R&D budget to develop newer and better products to meet market demands and customers requirement standard.

 ○ There has also been a growing global demand for disposable surgical products, growth in cardiovascular disease and orthopedic procedures, as well as strengthening of the legal framework IP for medical devices manufacturers.

 ○ Technological convergence between diagnostic, monitoring and treatment devices will be another major driver as medical professionals view the merging of technology as the next big step in accurately delivering drug treatments on time and in specific doses while conducting regular diagnostic and monitoring procedures.

 ○ Self monitoring blood glucose and insulin injection devices will see increased demand, spurred by an increased level of awareness as well as an increase in the number of diabetic patients within the country which are currently standing at about 1.8 million people, though a good 80% more of diabetics in need of treatment, are yet undiagnosed.

 ○ Doctors are also actively prescribing medical devices such as the Insulin Pump and Blood Glucose Monitor for Type I Diabetic patients to help patients to monitor blood glucose level and administer regulated insulin at the same time.

 ○ The pressing need to address and curb an increasing number of infectious diseases and hospital-acquired infections such as H1N1, MRSA will naturally result in a strong move toward disposables, signifying this is an area of high growth potential.

 ○ Malaysia manufacturers are already implementing technological advances in disposables, especially medical gloves, catherers, etc and many companies have already set the stage to become leaders within the industry.

 ○ More than 50 per cent of Malaysia’s medical devices production focuses on gloves.

 ○ There are also firms producing innovative kits for blood collection, which design and manufacture innovative medical devices and procedure packs for global healthcare markets. These products are sold in more than 35 countries and initially focusing on infection control, they now are prominent in safety and innovation.

 ○ The local medical devices industry is an export-oriented industry, Thus, the potential for Malaysia to increase its market share and capture an even bigger slice of the global market is a very attractive proposition, which could immensely benefit the Malaysian economy.

 ○ Opportunities are also abound to set up design and manufacturing innovation clusters for high-end medical devices e.g. cardiovascular, orthopedic implants, etc. There has been a global push for implantable devices based on the Asian physiology.

 ○ For example, Malaysia by market forces has developed a dynamic cluster focusing on the entire value chain of orthopedics from biopharma growth factors and natural supplements to implantable devices. In order to fast track this sector, centres of excellences in orthopedics are required so that products can move from bench to bedside much quicker.

 ○ Under the Industrial Malaysia Plan 3, US$234 million(RM800 million) has been targeted as investment in medical devices/ equipments for 2010.

 ○ Since Malaysia is still highly dependent on imports, high-tech medical equipment is highly sought after given the increasing demand for medical devices.

 ○ Major products imported were:

  - Medical/ Surgical or Laboratory Sterilizers, Instruments and Appliances used in Medical/ Veterinary Sciences

  - Orthopedic products

  - Hearing aids

  - Pacemakers

     and many other medical devices as listed under the ‘Import’ category.

3. Import and Export Trend

□ Imports

 ○ While Malaysia does manufacture a number of rubber based medical products, 90% of its medical devices are imported. Of this, Singapore has the largest market share 18.85%; followed closely by the United States(USA) 18.50%. This is based on the import statistics from January to June 2012 for products coded with HS90.18.

 ○ In the first half of 2012, imports of medical devices amounted to USD 313.88554 millions, an increase of around 13.75% compared to 2011.

 ○ Imports of Medical Devices into Malaysia

World Trade Atlas

Malaysia – Imports (9018 N-El Med/ Surg/ Etc Ins)

January – June, 2012

(Unit: Millions of US Dollars, %)

Rank	Country	Value			Change
		2010	2011	2012	12/11
-	World	213.950496	275.945727	313.88554	13.75
1	Singapore	39.762615	55.197811	59.194527	7.24
2	United States	43.93438	63.439555	58.072988	-8.46
3	Japan	26.603495	23.67609	40.260072	70.05
4	Germany	28.47669	29.708819	35.063705	18.02
5	India	8.391132	4.406975	26.182928	494.12
6	China	10.26794	15.231444	16.481409	8.21
7	Hong Kong	9.082846	10.510819	11.992808	14.1
8	Netherlands	7.268323	6.345527	8.041066	26.72
9	United Kingdom	5.832312	5.488094	7.265464	32.39
10	Korea, South	3.760456	6.475555	6.625558	2.32

Source: Department of Statistics Malaysia

 ○ South Korea is the tenth major exporter of medical devices to Malaysia, with Malaysia importing about US$6.625558 millions of products coded HS90.18 from January to June 2012.

 ○ Local importers/ traders such as Philips, BBraun, Omron and Maluri Equipment are commonly located in Central Malaysia and supply various kinds of medical devices and replacement parts to support the medical and healthcare industry in Malaysia.

 ○ Some of the major products imported into Malaysia were listed below:

  - Mechano Therapy, Massage Appliances

  - Physiological Aptitude Testing Equipment

  - Instruments for checking blood pressure

  - Orthopedic and Ophthalmic Appliances

  - Hearing Aids

  - Dental instruments and related parts

  - Thermostats

  - Medical Sterilises

  - Alpha, Beta, Gamma radiation apparatus, X-ray tubes

  - Electrocardiographs and Pacemakers

  - Microscopes

 ○ Imports are expected to continue growing at a strong rate, in line with rising health expenditure growth, and the country;s heavy reliance on imports to meet its healthcare needs.

□ Exports

 ○ Based on the export table below, total exports for medical devices coded HS 90.18 amounted to US$402.909715 millions(approximately RM12 billion) in the first half of 2012.

 ○ In fact, Malaysia’s export of medical devices is expected to hit RM12.5 billion this year compared with RM11.7 billion in 2011.

 ○ The increase is slight because of the crisis in Europe and also the stronger ringgit.

 ○ Major exports include surgical and examination gloves, dental and ophthalmic instruments and appliances. Malaysia is currently the world’s leading producer and exporter of surgical gloves and catheters, supplying 80% of the world market for catheters and 60% for rubber gloves.

 ○ However, the share of these two sub-categories have slowly started to diminish within the steady growth of diagnostic imaging exports in recent years, particularly electrocardiographs and other electrodiagnostic apparatus.

 ○ The bulk of medical devices produced in Malaysia still belong to Class 1 non-invasive products such as gloves though and Class 2 products which include semi-invasive devices like catherers and critical surgical wear. The size of Class 1 medical products produced in Malaysia is getting smaller due to competition from low-labour cost countries, while Class 3 invasive medical devices are gradually being produced more in Penang.

 ○ Reference

 ○ Exports of Medical Devices into Malaysia

World Trade Atlas

Malaysia – Exports (9018 N-El Med/ Surg/ Etc Ins)

January~June, 2012

(Unit: Millions of US Dollars, %)

Rank	Country	Value			Change
		2010	2011	2012	12/11
-	World	269.362606	415.130548	402.909715	-2.94
1	United States	56.627102	108.828637	106.614342	-2.03
2	Germany	67.942037	68.210518	80.469972	17.97
3	Japan	53.545664	68.878515	67.476585	-2.04
4	Singapore	18.647937	47.194186	29.538396	-37.41
5	Belgium	4.94587	14.496862	12.496126	-13.8
6	Denmark	9.074687	9.600197	12.265882	27.77
7	China	8.423148	8.969538	9.72162	8.38
8	Australia	8.507826	11.870082	9.213952	-22.38
9	India	6.266131	8.562705	7.849448	-8.33
10	Italy	1.072634	5.8324	6.510801	11.63
19	Korea, South	1.345556	2.180727	2.976834	36.51

Source: Malaysia Custom Office (http://tariff.customs.gov.my)   

□ Import Management System

 ○ The term ‘medical device’ covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability.

 ○ The Medical Device Bureau(MDB)(www.mdb.gov.my) is responsible for the regulation of medical devices on the Malaysian market. The range of medical device products is very wide. It includes contact lenses and condoms, heart valves and hospital beds, resuscitators and radiotherapy machines, surgical instruments and syringes, wheelchairs and walking frames or other assistive technology products, pregnancy tests, blood glucose monitors and pacemakers – many thousands of items used each and every day by healthcare providers and patients.

 ○ However, medical devices do not include ambulance vehicles, general workshop equipments such as power or machine tools or general purpose laboratory equipments.

 ○ There are three types of medical devices outlined in the legislation. They are as follows:

  - General medical devices

  - Active implantable medical devices

  - In-vitro diagnostic medical device

 ○ Presently there is no statutory requirement to register medical devices in Malaysia prior to sale or commerce, neither the establishments’(manufacturers, importers, distributors) license necessary when dealing with medical devices.

 ○ Members of the medical device industry will be notified of the statutory requirement to register medical devices and apply for establishment’s license when the appropriate legislation is brought into operation and enforcement by notification through a government gazette.

 ○ However, voluntary registration is currently encouraged by the Malaysian Government. The Voluntary Registration Scheme for Medical Devices Establishments(MeDVER) was launched in early 2006 as an initial step towards the implementation of medical devices regulation.

 ○ The implementation of MeDVER will continue until the Medical Device Act 2012 is fully enforced in two years’ time (yet to be determined even though it has been gazetted in February 2012) and it is meant as a confidence building stage whereby establishments dealing with medical devices in Malaysia are encouraged to participate and register their establishments with MeDVER.

 ○ MeDVER is a web-based registration system and is designed to serve the following purposes:

  - To familiarize all affected parties with the registration process

  - To gauge the readiness of medical devices establishments in conforming to the regulatory requirements

  - To prepare a smooth transition into the mandatory phase before the full enforcement of medical devices regulation

  - To obtain a profile of the Malaysian medical devices industry

 ○ All applications for MeDVER shall be made online. It consists of 2 parts; namely:

  - Part 1: The account creation system; and

  - Part 2: the system for obtaining information pertaining to medical devices establishment with respect to company profile, person responsible, medical devices particulars and pre and post-market details.

 ○ More details can be found here: http://www.mdb.gov.my/portal/medver/.

 ○ However, MeDVER is not an approval system. Assignment of submission number and registration number does not in any way constitute an admission or agreement by the Ministry of Health Malaysia to denote approval of an establishment and its devices.

 ○ It is recommended that the following parties who deal with medical devices and operate their businesses in Malaysia are encouraged to participate in this voluntary registration scheme:

  - Manufacturers of medical devices

  - Exporters and importers of medical devices

  - Distributors of medical devices

 ○ Apart from the Medical Device Control Division, the Atomic Energy Licensing Board of the Malaysian Ministry of Science, Technology and Innovation is also one of the regulatory bodies that exclusively regulates medical devices which emit radiation.

 ○ Devices emitting radiation are restricted and any such device must be examined by the Ministry of Health before it can be used in Malaysia. Permits for radiation emitting devices can be obtained through the Atomic Energy Licensing Board at the website: http://www.aelb.gov.my/aelb/engv/text/engindex.asp

 ○ Medical Device Act 2012 or Act 737 and the Medical Device Authority Act 2012 or Act 738

  - The Medical Device Act 2012 or Act 737 and the Medical Device Authority Act 2012 or Act 738 have been gazetted on 9th February 2012. The Acts can be downloaded via the following website:http://www.federalgazette.agc.gov.my/eng_main/main_akta.php?jenis_akta=Baru

  - Act 737 will come into effect next year and undergo a transition period before it is fully enforced in two years’ time(2014). The Act specifies requirements for medical device product registration, establishment licensing and conformity assessment body(CAB) registration.

  - Whereas Act 738 details out the organization of a regulatory body that will implement Act 737.

  - Currently, the Medical Device Bureau is undergoing drafting of its Subsidiary Legislations and Guidelines. Once the effective date is announced, medical devices are required to be registered and establishments will be licensed. All conformity assessment bodies will also be registered during the transition period.

  - The Medical Device Control Division also informed that it has not given out any appointment to any person or company on its behalf to conduct quality management system(QMS) audit based on ISO 13485 or Good Distribution Practice for Medical Device(GDP MD).

□ Import Customs and Tax

 ○ There is no import prohibition allotted for these specific HS Codes and products.

 ○ Based on the ASEAN-Korea Free Trade Agreement(AKFTA), there is neither import tax nor sales tax for the importation of products coded HS 90.18 into Malaysia.

HS Code	Tax rate	AKFTA	Units	Remarks
90.18				Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments
				- Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters):
9018.11.000	NIL	NIL	U	- Electro-cardiographs
9018.12.000	NIL	NIL	U	- Ultrasonic scanning apparatus
9018.13.000	NIL	NIL	U	- Magnetic resonance imaging apparatus
9018.14.000	NIL	NIL	U	- Scintigraphic apparatus
9018.19				-- Other
9018.19.100	NIL	NIL	U	Self-monitoring apparatus used in diagnosing diabetes
9018.19.900	NIL	NIL	U	Other
9018.20.000	NIL	NIL	KG	-- Ultra-violet or infra-red ray apparatus
				- Syringes, needles, catherers, cannulae and the like:
9018.31.000	NIL	NIL	U	-- Syringes with or without needles
9018.32.000	NIL	NIL	KG	-- Tubular metal needles and needles for sutures
				-- Other:
9018.39.100	NIL	NIL	U	Catheters
9018.39.900	NIL	NIL	U	Other
				- Other instruments and appliances used in dental sciences:
9018.41.000	NIL	NIL	KG	-- Dental drill engines, whether or not combined on a single base with other dental equipment
9018.49.000	NIL	NIL	U	-- Other
9018.50.000	NIL	NIL	KG	- Other ophthalmic instruments and appliances
				-- Other instruments and appliances:
9018.90.100	NIL	NIL	U	Self-administrating used in treating diabetes
9018.90.200	NIL	NIL	U	Artificial kidney (dialysers)
9018.90.300	NIL	NIL	U	Manually breast hand-pump
				Other:
9018.90.910	NIL	NIL	U	For veterinary sciences
9018.90.990	NIL	NIL	U	Other

Source: Malaysia Custom Office at http://tariff.customs.gov.my

4. Distribution Structure

 ○ Below shows the general distribution structure for medical devices in Malaysia.

General Distribution Structure of Medical Devices in Malaysia

5. Quality Certification

 ○ Malaysia requires all devices regarded as experimental in their home country to be internationally certified before being used in Malaysia.

 ○ The forthcoming Medical Device Act is expected to be based on FDA or European certification (European CE Marking) per Global Harmonization Task Force(GHTF) guidance documents as evidence of acceptability for Malaysia.

 ○ International consensus standards are a tool for harmonizing regulatory processes to ensure the safety, quality and performance of medical devices.

 ○ There are two standards:

  - Malaysian standards

  - International standards

     These standards will be attached together with the report.

 ○ The requirements for a quality management system that is accepted by MDB for regulatory purposes and based on international recognized standards, combined with the other conformity assessment elements are intended to ensure that medical devices will be safe and perform as intended by the manufacturer.

 ○ A manufacturer needs to demonstrate its ability to provide medical devices that consistently meet both customer and regulatory requirements. Manufacturers demonstrate compliance through an established and effectively implemented quality management system that meets the regulatory requirements.

 ○ The scope and complexity of the quality management system that a manufacturer needs to establish is influenced by varying needs, objectives, the products provided, processes employed, the size and structure of the organization and the specific regulatory requirements.

 ○ Processes required by the quality management system but carried out on the manufacturer’s behalf by third parties remain the responsibility of the manufacturer and are subject to control under the manufacturer’s quality management system.

 ○ As part of the Medical Device Control Division/ CAB’s conformity assessment process they should assess the adequacy of this control.

 ○ Conformity assessment of the manufacturer’s quality management system is influenced by the class of the medical device.

 ○ For Class B, C and D devices, the MDCD or CAB needs to be satisfied that the manufacturer has an effective quality management system in place, appropriate for the device under assessment. In doing this, the MDCD or CAB will consider any relevant existing certification and, if not satisfied, e.g. with its scope or with post-market performance history, may carry out an on-site audit of the manufacturer’s facility.

 ○ Manufacturers of Class C and D devices should have a full quality management system that includes design and development. Manufacturers of Class B devices should have a quality management also; however the procedures incorporated within it may not include design and development activities. Manufacturers of Class A devices are expected to have the basic elements of a Quality Management System(QMS) in place but need not include design and development activities.

 ○ The QMS for manufacturers of Class A devices is normally not subject to premarket on-site audit by the MDCD or CAB.

 ○ As for conformity assessment of device safety and performance, the manufacturer will establish a subset of technical documentation to be held or submitted to MDCD or CAB as required by the class of the device. The MDCD or CAB determines the adequacy of the documented evidence in support of the manufacturer’s attestation of conformity to the essential principles of safety and performance through a review of the GHTF guidance document: ‘Common Submission Dossier Template for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices(CSDT)’.

 ○ The four tables below summarise conformity assessment elements that apply to Class A, B, C and D devices:

6. Potential Buyer List

□ KMT Trading Sdn. Bhd.

Address	Suite P5.05, BICMA Center, Lot 2, Jalan 243/51A, 46100 Petaling Jaya, Selangor, Malaysia.
Telephone	+603-7877 5528
Fax	+603-7877 5521
Contact person	Mr. Andrew (Director)
E-mail	aventispharma@gmail.com
Website	http://aventispharma.com.my/about.html
Remarks: - Aventis Pharma generally supplies ophthalmic products to ophthalmologists, private and government hospitals. - Zeiss and Nippon Tokusei are some of the brands that they are carrying.

□ SJ Farma (Malaysia) Sdn. Bhd.

Address	42-2, Jalan USJ 1/33, 47600 Subang Jaya, Selangor, Malaysia.
Telephone	+603-8023 7678
Fax	+603-8023 7763
Contact person	Mr. Andrew Ng (Business Development Manager)
E-mail	Andrew_ng@sjfarma.com
Website	http://sjfarma.com/about.html
Remarks: - SJ Farma usually distributes medical related products imported from Germany, the US as well as European owned companies that are based in China.

□ Intermedex Sdn. Bhd.

Address	No. 21, Jalan Puteri 5/16, Bandar Puteri, 47100 Puchong, Selangor, Malaysia.
Telephone	+603-8068 2516
Fax	+603-8068 3517
Contact person	Mr. Lionel Yew (Executive Director)
E-mail	info@myintermedex.com
Website	N/A
Remarks: - The company is also a manufacturer for medical and hospital supplies. However, they do import and distribute some medical products such as ICU supplies and anesthetics imported from other countries like Korea and the US.

□ Eye Nation Medical Sdn. Bhd.

Address	28-1, Jalan Puteri 5/5, Bandar Puteri Puchong, 47100 Puchong, Selangor, Malaysia.
Telephone	+603-8065 1421
Fax	+603-8065 1423
Contact person	Mr. Edmund Lee (Manager)
E-mail	Edmund@eyenation.com.my
Website	http://www.eyenation.com.my/index.php
Remarks: - The company is a sole distributor for a number of ophthalmic related products in Malaysia. They are currently dealing with brands like Hoya, Mani, Lenstec, Trusetal and Alchimia.

□ Medi-Care Products Sdn. Bhd.

Address	No. 30-A, Lorong Taman Ipoh Satu, Taman Ipoh Selatan, 31400 Ipoh, Perak, Malaysia.
Telephone	+605-545 7814
Fax	+605-547 5520
Contact person	Miss Jesamine The (General manager)
E-mail	jesamineteh@medi-care.com.my
Website	http://www.medi-care.com.my/aboutus.html
Medi-Care is a distributor of medical supplies, equipments and implants in which they usually import from France, the US and Singapore. They are the authorized distributor for 3M, Medicrea, eNasco and Germitrol.

□ Kens FineMedTech Sdn. Bhd.

Address	19, Hilir Sungai Keluang 2, Taman Perindustrian Bayan Lepas, Fasa IV, 11900 Penang, Malaysia.
Telephone	+604-616 1356
Fax	+604-616 1353
Contact person	Mr. Leow (General Manager)
E-mail	khleow@kensfinemedtech.com
Website	http://www.kensfinemedtech.com.my/
Kens FineMedTech is a subsidiary of Crest Focus Sdn Bhd. They are a contract manufacturer for orthopedic devices, implants and tools.

□ Malex Medical Asia (M) Sdn. Bhd.

Address	19-1 Block E1, Jalan PJU 1/42, Dataran Prima, 47301 Petaling Jaya, Selangor, Malaysia.
Telephone No.	+603-7880 0192
Fax No.	+603-7886 3946
Contact person	Mr. Benny Paul (General Manager)
E-mail	Bpaul@malexmedical.com
Website	http://www.malexmedical.com/
- Malex supplies products in a wide range of medical field, namely, surgical, urology, orthopedic, neurocardiology, peripheral vascular interventions and emboli and thrombus management. - Arthrex, BonAlive, Biomaterials, Finceramica, ev3, Straub medical and Promedon are examples of brands that they are dealing with.

□ M-Urus Medik Sdn. Bhd.

Address	No. 7, Jalan Bunga Tanjung 20, Taman Seraya, Jalan Cheras, 56100 Kuala Lumpur, Malaysia..
Telephone	+603-4296 7278
Fax	+603-4296 8278
Contact person	Mr. Syawal (Manager)
E-mail	m.urusmedik05@gmail.com
Website	N/A
Specializes in importing and distributing medical products in Malaysia and also in Indonesia

□ Perintis Medik Sdn. Bhd.

Address	11-1 & 2, Jalan USJ 21/6, UEP Subang Jaya, 47630 Selangor, Malaysia.
Telephone	+603-8023 6182
Fax	+603-8023 9781
Contact person	Mr. Wong Chih Choong (Managing Director)
E-mail	cc.wong@perintismedik.com
Website	http://perintismedik.com
- Perintis Medik deals with various types of orthopedic products like spinal/neuro implant instrument, Minimally Invasive Spinal Surgery like vertebroplasty and kyphoplasty, bone graft, oncology implant and many more.

□ Imbas Wawasan Sdn. Bhd.

Address	B 2-2-2, Solaris Dutamas No 1, Jalan Dutamas 1, 50480 Kuala Lumpur.
Telephone	+603-2630-5524/ +6012-901-0566
Fax	+603-6205 3623
Contact person	Mr. Faizal (director)
E-mail	Imbas2020@yahoo.com
Website	N/A
The company imports various medical equipments from Germany and the USA.

□ Abex Medical System Sdn. Bhd.

Address	Lot 2-6, Jalan SU/6A, Lion Industrial Park, Section 26, 40400 Shah Alam, Selangor.
Telephone	+603-5191 6633
Fax	+603-5191 1933
Contact person	Mr. Faizal (director)
E-mail	swooi@abexmedical.com.my
Website	www.abexmedical.com,my
- The company supplies, installs, tests, commissions and repairs medical equipments. - Usually deals with highly sensitive medical imaging equipments like CT, MRI, Angiography, X-ray and Ultrasound imaging systems