By Stewart Eisenhart, Emergo Group
Medical device market regulators in Malaysia have implemented several new policiespertaining to the country’s recently enacted Medical Device Act.
Recent Medical Device Authority (MDA) policies target five key areas: authorized representation, Conformity Assessments, registration exemptions, export/import requirements and Good Manufacturing Practice (GMP) certifications for establishment licensing.
Authorized representation
First, the MDA has clarified that each medical device imported into Malaysia for sale must have a single authorized representative. Foreign manufacturers importing multiple medical devices into Malaysia may appoint more than one authorized representative for those products. In other words, firms may appoint multiple authorized representatives for their product lines, but two authorized representatives cannot be appointed for the same device.
Conformity assessment procedures
Second, Conformity assessment requirements for medical devices have been tied more closely by the MDA to products’ registrations in other markets. Devices commercialized in “recognized” markets—Australia, Canada, the European Union, Japan or the US—will undergo a simplified conformity assessment process by forregistration in Malaysia.
Simplified conformity assessments, or verifications, will be carried out by conformity assessment bodies (CABs) registered under Section 10 of the Malaysian Medical Device Act. Verification will include conformity assessments of eligible manufacturers’ quality management systems, post-market surveillance systems, technical documentation and declarations of conformity. However, it’s important to note that the extent of verification activities will depend on a particular device’s classification under the Malaysian system.
The MDA is allowing verification only for devices that have already undergone conformity assessments in recognized markets. As such, it appears as though EU Class I (non-sterile, non-measuring) devices, EU general IVDs and US Class I exempt devices would not qualify for verification and would have to go through full conformity assessment for Malaysian registration. Emergo Group’s Kuala Lumpur office is still researching this issue to determine how manufacturers of such devices will be impacted.
Registration exemptions
Third, the MDA has identified four categories of medical devices that will be exempt from Malaysian registration requirements:
- Low-risk devices listed in Appendix 1 of the Medical Device Act
- Custom-made devices used by medical practitioners
- Devices used by healthcare practitioners in emergency settings or in situations where conventional treatments have failed
- Devices used for clinical evaluation, demonstration or education
Manufacturers whose devices qualify for exemption must nonetheless notify the MDA before placing their products on the Malaysian market.
Import/export and transit issues
Fourth, regulators have further spelled out requirements for devices meant for export, as well as for devices imported from or exported to countries that have no diplomatic ties with Malaysia.
The MDA is now requiring Malaysian registration for medical devices intended for export only; devices intended for transit through Malaysia will not require registration, but regulators must still be notified of such devices.
Furthermore, authorities will not issue permits or Certificates of Free Sale for devices imported from or exported to countries such as Israel that have no diplomatic ties with Malaysia.
GMP and establishment licenses
Finally, the MDA has clarified quality system requirements for firms seeking establishment licenses in Malaysia. Through July 1, 2014, the regulator will accept GMP certifications from the National Pharmaceutical Control Bureau from manufacturers for establishment licensing purposes; beyond that deadline, manufacturers must have ISO 13485 quality system certification in order to obtain establishment licensing.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
