Malaysia Issues Draft Medical Device Advertising Law

(Marketingmagazine.com.my) – The Medical Device Authority of Malaysia (MDA) has issued a draft of the “Code of Advertisement for Medical Devices” to provide guidance “in ensuring good marketing practices and advertising messages which promote the quality use of medical devices in a socially responsible and ethical manner.”

According to the Guidance Document, only registered devices can be advertised and all claims surrounding the medical device must be accurate and unambiguous. 

In addition, medical device advertisements are self-regulated, therefore the “responsible person” for medical device advertisements must be the authorized representative of the medical device or an official third party representative.
Manufacturers advertising medical devices in Malaysia should be aware of the various requirements regarding advertisement claims. Important provisions in the current draft law include:

• Advertisements must not promote devices for unapproved patient groups.
• Advertising claims should be based only on scientific evidence and avoid ambiguous statements.
• Advertisements should not attack or discredit other medical devices or companies.
• Advertisements should avoid using “fear and superstition” to promote devices.
• All advertisements, regardless of medium, must include the full manufacturer’s name and contact number, establishment license number, name of medical device, and the medical device registration number.

In February 2016, the Malaysia Medical Device Authority (MDA) released a set of guidelines that will help medical device manufacturers comply with Malaysia’s regulations. The guidelines will support manufacturers as they complete the Declaration of Conformity, a legal document drawn up by manufacturers assuring that the device complies with all applicable laws.

The guidelines provide detailed definitions of key words found in the Declaration of Conformity. The guidelines also emphasize that the Declaration of Conformity must be signed by top management.

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‘2-day MBA’ in Marketing, ‘TED of Marketing’, call it what you will, and come what may, we will see you on May 19 & 20 at the Eastin Hotel.

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Says Chief Judge Adam Wee Abdullah, Group CMO of CIMB Banking Group about judging the entries, “Clarity in the Objective statement is fundamental. If this is not clear, the solutions will not be clear as well. It is also important to juxtapose the expected outcome against the Objective statement so you can gauge if the strategies are aligned. It’s a bit like looking through the scope of a sniper’s rifle.”

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APPIES Malaysia 2016 judges:

• Abdul Sani Abdul Murad – Head of Marketing, HSBC Malaysia

• Ben Mahmud – Head of Retail Marketing, Shell Malaysia Trading

• Eric Wong – Marketing Director, IBM Malaysia

• Fiona Liao – Chief Brand Officer, Prudential Assurance Malaysia

• Jasmine Lee – Chief Marketing Officer, U Mobile

• Jauhar Munir Shaikh – FVP, Brand Marketing for F&N Malaysia

• Loh Keh Jiat – CMO, Digi Telecommunications Sdn Bhd

• Mark Ng – ASEAN Marketing Director, Castrol

• Martin Soong – Marketing Manager, Fonterra Brands Malaysia

• Matthew Ho – Regional Digital Marketing Director, Huawei Technologies Malaysia

• Nirinder Singh Johl – GM of Strategic Communications, Tenaga Nasional Berhad

• Noreen Sabrina – Head of Brand Communications- Malaysia Digital Economy Corporation (MDEC)

• Pan Choi Yen – GM of Marketing, WIPRO-UNZA Malaysia

• Philip Whittaker – Group Chief Marketing Officer, Themed Attractions & Resorts

• Rizan Ismail – Head of Brand Management, PETRONAS

• Santharuban T. Sundaram – Group Marketing Manager, Permanis Sandilands

• Stephane Vilquin – Marketing Director, Campbell Soup Southeast Asia

• Syahar Khalid – Digital Engagement Manager, Nestlé Products Malaysia

• Vincent Chong – Marketing Director of Unilever Malaysia

• Zaki Zin – Marketing Director, Wyeth Nutrition Malaysia

• Zalman Aefendy Zainal Abidin – Chief Marketing Officer, Celcom AXIATA