March 8th, 2018

The Malaysian Islamic Development Department (Jakim) is expected to introduce halal certification for medical devices in the third quarter of this year. This major announcement was made by the Department’s Halal Hub Division director, Datuk Sirajuddin Suhaimee in early February 2018, who said the certification, drafted together with the Department of Standards Malaysia, was now at the final stage of public feedback.

In regards to this, in August 217, Jakim had released a draft guidance document, drafted in cooperation with Department of Standards Malaysia, for manufacturers who wish to get their medical devices Halal-certified. The Draft Guidance Document can be consulted in this link.

This Draft Guidance Documents, which is expected to officially be released by third quarter of this year, serves as a guide for the general requirements local and foreign manufacturers must adhere to, in order to get their medical devices Halal-certified. Halal refers to things or actions permitted by the Islamic Shariah law or fatwa, and Halal certification can be accorded to products which contain only Halal raw materials and manufactured via Halal procedures. This Halal-certification is mainly of concern for implantable medical devices or those which come directly in contact in vivo with the patient, for example, surgical sutures, heamodialysis liquid, irrigation solution, synthetic bones, dermal fillers, both of synthetic and natural raw materials and etc.

It is to be noted that once Jakim has officially implemented Halal certification regulations, it is not compulsory for all manufacturers who market their devices in Malaysia to get their devices certified. It is only a marketing strategy to get their target end-user circle bigger, as their number of target Muslim customers may increase following Halal-certification, just as it is implemented in the Halal food industry in Malaysia. Halal certification for medical devices applications are to be made separately with Jakim, just like hybrid medical device permits are regulated by the independent agency, Sirim QAS.

 

Reference:

1)  Draft Malaysian Standard: Halal medical device – General requirements

2) Jakim to introduce halal certification for medical devices