A New Bill of Health
The Medical Device Bill 2011 and Medical Device Authority Bill 2011
The Malaysian medical device market is an industry which is growing vigorously thanks to the robust economy and high demand from the public and private healthcare sectors. With about 200 medical device manufacturers in Malaysia, many of which have close ties to international companies producing medical products from syringes to radiographic equipment for various purposes ranging from diagnosis, therapy to surgery, the industry is valued at approximately RM700 million and is poised to in the coming years. The increased spending and expansion of the public and private healthcare sectors, driven by the demands of the public, is undoubtedly a significant contributor to this growth. This is complemented by the fact that Malaysia imports up to 90% of its medical devices, leaving much room for local expansion.
The medical devices industry is, at the moment, regulated by the Medical Devices Bureau of the Ministry of Health. Under the current regime and aside from radiation related medical devices, there is no obligation to register medical devices before they are used in Malaysia – anyone is allowed to import any medical device into Malaysia. This has led to concerns that there is inadequate supervision and control of the safety, quality and usage of medical devices.
In its effort to tackle such problems and to provide for regulatory oversight of medical devices which is on par with advanced economies, Parliament recently passed the Medical Device Bill 2011 (“MDB”) and the Medical Device Authority Bill 2011 (“MDAB”). Both bills have been in the works since 2005 and were crafted with the intention of harmonising the essential principles of safety and performance of medical devices as recommended by the Global Harmonization Task Force. The MDB and MDAB are expected to come into force by the end of 2011 or early 2012 and are expected to have a significant impact on the industry.
B. The New Regime
Medical Device Authority Bill 2011
The MDAB provides for the establishment of the Medical Device Authority (“Authority”) which falls under the purview of the Ministry of Health. Besides government officials, individuals with expertise and experience in matters related to medical devices will be appointed to the Authority. The Authority has the power to, amongst other things, implement and enforce relevant laws, regulate the industry and its activities, and encourage and promote development of the industry.
Medical Device Bill 2011
Under the MDB, all local and imported medical devices must be registered with the Authority. These include instruments, machines, implants and appliances used for, amongst others, diagnostic, monitoring and treatment purposes (“Device”). Manufacturers, including those who design, package and label Devices, will be required to comply with good manufacturing practices and Devices must be packaged and labelled in the manner prescribed by the Authority. Failure to register a Device will result in a fine not exceeding RM 200,000 and/or to imprisonment for a
maximum of three years.
In addition, manufacturers, importers and distributers (“Establishment”) not based in Malaysia are required to have a local presence through a Malaysian resident or company. Under the MDB, no Establishment is allowed to import, export or place in the market any registered Device unless it holds an establishment licence. Contravention of this provision will lead to a fine not exceeding RM 200,000 and/or imprisonment for a maximum of three years. The MDB seeks to impose stringent quality control obligations on Establishments as well. Establishments will be required to maintain distribution records of Devices, monitor the safety and performance of Devices, report problems with Devices to the Authority and undertake corrective action (including recalling defective Devices).
The MDB also provides for the establishment of Conformity Assessment Bodies (“CAB”), which would most likely be private companies with the necessary skill and practice, to be registered with the Authority to carry out conformity assessment of Devices to be registered under the MDB. A CAB which seeks to be registered must be under the control of a Malaysian citizen, be independent and must not have any direct or indirect interest in the Device or the Establishment in question.
The MDB also grants wide-ranging powers to authorised officers of the Authority (“Officer”). An Officer will have powers of investigation and be vested with the powers and rank of a police officer in relation to investigations and is allowed to carry out search and seizures. Officers may also summon persons involved in investigations to appear before them and may arrest without warrant any person who commits an offence under the MDB.
The passing of the bills is timely and represents a positive step towards ensuring that public health and safety is well protected. Moreover, it serves to enhance Malaysia’s access to more advanced technologies by promoting the trading of Devices as a result of having clear regulatory requirements in place. The efforts of the Government in introducing the bills should be lauded as it seeks to place the protection of patients and consumers of medical devices on par with those in developed nations.
This article was contributed by David Dass and Chor Jack of Christopher Lee & Co. (www.christopherleeco.com).
Article length : 809 words
Date : 25 November 2011
Contact : Kuok Yew Chen
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017 2111 320