Simple Understanding of Medical Supplies (Medical Device) in Malaysia
Medical supplies refers to the non-durable disposable healthcare materials ordered or prescribed by a doctor, which is primarily and customarily used to serve a medical purpose.
In Malaysia context, medical supplies are referred to as Medical Devices which are govern under the Ministry of Health Malaysia by Medical Device Authority. Since the gazette of Medical Device Act 2012 on 9th February 2012, medical devices in Malaysia is bound under the Law Of Malaysia. Parties responsible in placing medical devices in the market of Malaysia will need to adhere to the Medical Device Regulations 2012.
What are the types of Medical Devices?
In Malaysia, medical devices are categorized into general devices and in-vitro diagnostic devices (IVD). Each categories are further classified into 4 classes which are Class A, Class B, Class C and Class D devices.
Class A mainly covers medical devices which are of low risk like single use devices such as bandages, syringes, surgical face masks, latex gloves et cetera. Class B will covers low to moderate risk devices such as hypodermic needles and pregnancy tests. Whereas, Class C
consist of moderate to high risk medical devices such as lung ventilators and orthopedic implants. Lastly, Class D products, the highest level of risk for products such as heart valves and implantable defibrillators.
What are the factors that influence the device classification?
Well for one, it will depends on the duration of contact with the body. The longer the device need to be in contact with any part of the body, then the higher it is in classification. The more invasive of the device into the body , the higher the classification. Then whether the medical device delivers medicine or energy, whether it provides local or systemic effects, whether the device comes into contact with injured skin, whether its for diagnosis or treatment, the ability for its reuse or not and whether there is combination with drugs, will influence their classification.
At times, products may be difficult to classify, in this case, an establishment may need to send them in to the Medical Device Authority to do classification with a payment of cause. In this way, it will be a safer bet, since if the authority have decided that a particular product is not a medical device after assessing the information, they will issue a letter informing of so and this letter can be used to avoid clearance issue at customs. And with the correct classification, it will enable smoother registration process. There has been cases whereby establishment wrongly classify and asked to resubmit registration with a new application fees while no refund of the wrong registration fees is entertained.
So who can legally sell medical devices in Malaysia?
Medical Device manufacturer or Local Authorized Representations (LAR) are required to hold valid Establishment Licenses to enable them to manufacture, import or distribute medical devices in Malaysia. However, retailers are exempted from the requirement of a valid Establishment License though.
Nevertheless, it is not easy to apply for an establishment license. Each establistment need to be audited by Conformity Assessment Body (CAB) endorsed by Medical Device Authority. Each establishment will be required to establish it’s own Quality Management System (QMS) based on ISO 13485:2016 (for Manufacturer) or Good Distribution Practice For Medical Device (GDPMD)(for importer, distributors and wholesaler).
What is a Conformity Assessment Body?
A Conformity Assessment Body (CAB) is a legal entity that performs a conformity assessment of the Quality Management System against Medical Device Regulations and relevent standards. Once audits results are accepted, relevent certificates and audit reports will be released to the Establisment which will then be used apply for the Establishment License with Medical Device Authority. Medical Device Authority.
Company wish to apply for Establishment LIcense would need to appoint CAB registered with the Medical Device Authority. Examples of registered CAB are TUV SUD PSB (M) SDN BHD, SIRIM QAS INTERNATIONAL SDN BHD, CARE CERTIFICATION INTERNATIONAL (M) SDN BHD et cetera.
But how do we actually choose from the list of CABs? Costing is one big determining factor, however, most of the CABs do follow a standard costing range and charge by man hours. CABs which are international entity would usually be a consideration if a company wish to venture into international market as the QMS certification from those CABs will be internationally recognised. If an establishment would like to just fulfill the basic requirement of local authority, in this case the medical Device Authority, Ministry of Health Malaysia, certification from any of the registered CAB with Medical Device Authority, would be sufficient.
Registration of medical devices in Malaysia
When a company have the license to “place in the market”, before they are allowed to actually sell the products, the said medical device need to be registered. Since the gazette of the Medical Device Act 2012, there was a transition period whereby medical devices already existing and selling in Malaysia market has to go through the process of registration so that they are legally accepted to be in the market for sale.
Since 1st July 2017, it has been mandatory to sell only registered medical devices in Malaysia market. Ever since the implementation of this Medical Device Act, companies that wish to sell any new product which is classified as medical device, it has to go through the process of registration with the Medical Device Authority before it can be legally sold in the open market in Malaysia. Why do I say “legally”? Well for one, if one would to bring in any products, which in Malaysia context would be regarded as medical device, if that person did not register the products but yet face no restriction during custom clearance, it will still flow into the market without any problem. It will pretty much depend on the enforcement of the relevant authority to screen them out from the market. At least at this moment of time.
If you wish to know more about the medical devices available from our company, please contact us at admin@medimexmy.com
