DIRECTOR GENERAL OF HEALTH MALAYSIA
ONLY SAFE & EFFECTIVE MEDICAL DEVICES ARE ALLOWED IN MALAYSIA
In reference to the article published in The Sun Daily dated 12 July 2015 titled ‘Citizen Nades-Nine months and counting’, the Ministry of Health (MOH) would like to make some clarifications.
The Medical Device Act 2012 (Act 737) was gazetted on 9 February 2012 and came into operation on 30th June 2013. The objective of this Act is to regulate medical devices, the industry and to provide for matters connected thereto.
On the allegation of hospitals using critical lifesaving equipment that have not met essential requirements, the Act requires all medical devices to be registered with the Medical Device Authority (MDA) before they can be placed in the Malaysian market. Furthermore, all establishments which include manufacturers, authorised representatives, distributors and exporters are required to be licensed before they are allowed to do business in the medical device industry in the country. The two main provisions of this Act which underline the above are:
- Section 5(1): No medical device shall be imported, exported or placed in the market unless the medical device is registered under this Act.
- Section 15(1): No establishment shall import, export or place in the market any registered medical device unless it holds an establishment licence granted under this Act.
Furthermore, the Act also provides provisions on the transition period from the appointed date to assist the industry. This is to ensure continuous accessibility of medical device for public use during the initial stage of implementation of the Act whereby under:
- Section 80 (1) : A person who, prior to the appointed date, has imported, exported or placed in the market medical devices shall, within twenty four (24) months from the appointed date, apply for the registration of the medical devices under Section 6.
- Section 80(2): A person who, prior to the appointed date, has been importing, exporting or placing in the market medical devices and intended to continue importing, exporting or placing in the market such medical devices shall, within twelve (12) months from the appointed date, apply for an establishment licence under section 16.
- Section 80 (3): A person referred to in sub section (1) or (2) may continue to import, export, or place in the market the medical devices pending determination of its application for registration of a medical device or for an establishment licence as the case may be.
This means that any establishment which has submitted the application for licence during transition period i.e. before 1 July 2014 may continue their business as usual pending approval of its application. With regards to the allegation that the MOH is purchasing equipment from a company that has not met the basic requirement of the Act, MDA cannot ascertain the establishment in question is meeting the requirements of the Act as the investigation is still ongoing.
As stressed by the Minister of Health in The Sun Daily dated 13 July 2015 pertaining to medical device registration, the transitional provision allows the medical device to continue to be placed in the market pending registration approval, provided that the application for registration has been made by the establishment during the transitional period. This transitional period which was initially 1 July 2015 has now been extended for another year until 1 July 2016 by an order signed by the Minister to assist the industry. However, MDA will monitor the post market activity to ensure that the medical devices placed in market are safe and effective as provided by Sections 37-42 of the Act.
As mentioned by the Director General of Health Malaysia on the issue of the role of MDA in certifying medical devices, it is a requirement under section 7(1) (a) that all medical device will be subjected to conformity assessment by a conformity assessment body to ensure it meets the essential requirements prior to its registration. Currently, this requirement is still under transition period as according to Section 80 (1) and (3) of the Act.
With regards to the allegation that the MDA refused to implement the law, we would like to stress that MDA is committed to implement and enforce the law effectively to ensure that only safe and effective medical devices are placed in the Malaysian market for public consumption. MDA would like to reiterate that the investigation is still ongoing. It is the duty of MDA to observe all the standard operating procedures including in carrying out detailed and thorough investigation to ensure that the evidence is reliable and submissive in the court of law. This process involves the integrity of the investigation and may be time consuming. In addition, legal advice need to be sought in order to minimise any shortcoming during the enforcement process.
The Medical Device Authority (MDA) is constantly responding to all complaints and takes action against any contravention of Act 737 and will take the necessary actions in accordance with the provisions of the law. Enforcement action will be undertaken by MDA to prevent recurrence of breach of the Act.
DATUK DR. NOOR HISHAM BIN ABDULLAH
Chairman of Medical Device Authority
Director General of Health Malaysia
Ministry of Health Malaysia
15 July 2015