8 January 2020

The Malaysian Parliament has gazetted the Medical Device (Advertising) Regulations 2019 (P.U. (A) 317) and Medical Device (Duties and Obligations of Establishments) Regulations 2019 (P.U. (A) 318) under Section 79 of the Medical Device Act 2012 (Act 737) (“Act”) which will only come into effect on 1 July 2020 to allow stakeholders adequate time to comply with all the regulatory requirements.

The Medical Device Authority (“MDA”) is a federal statutory agency under the purview of the Ministry of Health of Malaysia which seeks to regulate medical devices, the medical device industry and its activities.

The new Regulations provide clarity to the restrictions on advertising of medical devices under the Act and duties of persons or companies who are deemed “establishments”. An “establishment” is a person who is either a manufacturer, importer or distributor who is responsible for placing any medical device in the market but does not include a retailer and an authorized representative appointed by a manufacturer having a principal place of business outside Malaysia. Such person and authorized representative must be a person domiciled or resident in Malaysia, or a firm or company constituted under the laws of Malaysia and carrying on business or practice principally in Malaysia.

Advertising of Medical Devices

Prior to the provision of the Medical Device (Advertising) Regulations 2019, the Act merely prohibits advertising of any unregistered medical device and claims in respect of a medical device which are misleading or fraudulent without providing for a legitimate manner in which medical device may be advertised. To complement this prohibition under the Act, the Regulations now specifically provide that mandatory prior approval of the MDA be sought for advertising a registered medical device. Failure to do so is a criminal offence which on conviction attracts a fine not exceeding RM200,000.00 or imprisonment for a term not exceeding 2 years or both.

When seeking the MDA’s approval the applicant should provide (i) a copy of the proposed advertisement; (ii) a processing fee of RM1,000.00; and (iii) a letter of appointment from the establishment on whose application the medical device is registered to, if the applicant is appointed by the establishment to advertise the medical device.

Further, the Regulations also provide that the advertisement should contain a statement that the medical device is registered under the Act and the registration number assigned to the medical device.

Duties and Obligations of Medical Device Establishments

The Medical Device (Duties and Obligations of Establishments) Regulations 2019 prescribes the manner, criteria, conditions and procedures of post-marketing activities of medical devices which are set out below:

1. Keeping distribution records
   • An establishment is obliged to maintain the distribution records for 2 years after a medical device is placed in the market, or 2 years from the date the medical device is shipped out of Malaysia, if it is intended for export. If the medical device has a projected useful life, the records should be maintained for the projected useful life as determined by the manufacturer.
   • The relevant Regulation also sets out information which should be contained in the distribution records in respect of each medical device manufactured, imported, exported and placed in the market as well as additional information which are required if the medical device is implantable.

2. Keeping records of complaint handling
   • An establishment should ensure that a record of complaint handling contains procedures relating to assessment of a complaint, investigation carried out by the establishment, corrective and preventive actions taken by the establishment, communication with complainant and maintenance of record.
   • Information such as details of the medical device and the complainant, description of the complaint and the incident related thereto, and any other information which may be helpful to the investigation of the incident should also be included in the records on a complaint relating to a medical device.
   • Such records should be kept for 5 years, in addition to the projected useful life of the medical device .

3. 3. Undertaking mandatory problem reporting
      • Under the Act, it is mandatory for an establishment to report to the MDA any incident occurring inside or outside Malaysia that:
        1. is related to the failure of the medical device or a deterioration in its effectiveness, or any inadequacy in its labelling or instructions for use within 30 days from the discovery;
        2. has led to the death or serious deterioration in the state of health of a person, or could do so if the incident were to recur within 10 days from the discovery; or
        3. is a serious threat to public health within 48 hours from the discovery.

3. • An investigation and if necessary, a field corrective action is to be conducted after submission of the aforesaid mandatory report to the MDA.
   • The investigation report is to be submitted by the establishment to the MDA within 30 days from the date of submission of the mandatory report or within any extension of time granted by the MDA. The MDA may close the matter and notify the establishment of its decision in writing if it is satisfied with the action taken.
   • If the MDA is dissatisfied with the action taken by the establishment, it may order the establishment to carry out further investigation and submit a revised investigation report, or to recall the medical device. Alternatively, the MDA may cancel the medical device registration, or suspend or revoke the establishment licence.
   • However, if an incident occurring abroad has been reported by the establishment to the regulatory agency of the country in which the incident occurred and a field corrective action has been taken by the manufacturer or establishment, there is no need to submit another mandatory report to the MDA.

4. Undertaking field corrective or preventive action
   • Under the Act, a corrective or preventive action in relation to a medical device imported and placed in the market includes the return of the medical device to the establishment, modification, exchange, or destruction of the medical device, or specific advice on the use of the medical device.
   • An establishment should notify the MDA before taking any field corrective or preventive action .
   • After the completion of the field corrective or preventive action, the establishment is required to submit a report of field corrective or preventive action to the MDA. The MDA may close the matter and notify the establishment of its decision in writing if it is satisfied with the corrective or preventive action taken.
   • If the MDA is dissatisfied with the action taken by the establishment, it may order the establishment to take further action to ensure the safety and performance of the medical device, or to recall the medical device. Alternatively, the MDA may cancel the medical device registration, or suspend or revoke the establishment license.

5. 5. Undertaking voluntary recall
      • A voluntary recall may be classified as follows:
        1. Class I recall – a high risk recall in situation where there is a high possibility that the defective medical device will cause serious health problems or even death;
        2. Class II recall – a medium risk recall in situation where there is either a possibility that the defective medical device will cause temporary or reversible health problems, or there is a remote possibility that the defective medical device will cause serious problems;
        3. Class III recall – a low risk recall in situation where there is a probability that using or being exposed to the defective medical device will cause health problems.

5. • Before undertaking a voluntary recall of medical device, an establishment should notify the MDA and all persons affected by the recall in not less than 48 hours before the recall is made (for Class I recall), not less than 3 days before the recall is made (for Class II recall), or not less than 5 days before the recall is made (for Class III recall).
   • Within 30 days after the completion of a voluntary recall, the establishment is required to submit a report to the MDA. The MDA may close the matter and notify the establishment of its decision in writing if it is satisfied with the report submitted.
   • If the MDA is dissatisfied with the voluntary recall taken by the establishment, it may order the establishment to take any other necessary action to ensure that the medical device is not available in the market. The MDA may also cancel the medical device registration, or suspend or revoke the establishment license.
   • The MDA may publish information of the voluntary recall of a medical device to the public.

6. Undertaking mandatory recall
   • The MDA may, in writing, order an establishment to recall any medical device at any time due to patient safety and public health, in which case the establishment should do as required and report the results of the recall within a period as may be determined by the MDA. The MDA may close the matter and notify the establishment of its decision in writing if it is satisfied with the report submitted.
   • If the MDA is dissatisfied with the report, it may order the establishment to take any other necessary action to ensure that the medical device is not available in the market. Alternatively, the MDA may cancel the medical device registration, or suspend or revoke the establishment license.
   • The MDA may publish information of the mandatory recall of a medical device to the public.

A person may be charged with a criminal offence for contravening with the Regulations relating to any of the above obligations and will on conviction, be liable to a fine not exceeding RM200,000.00, or to imprisonment for a term not exceeding 2 years, or to both.

If you have any queries or require more information, please feel free to get in touch with us.


Lee Lin Li
Partner
T: +603 2050 1898
linli.lee@taypartners.com.my


Lim Jing Xian
Associate
T: +603 2050 1833
jingxian.lim@taypartners.com.my