Malaysia Halal Medical Device Standard MS 2636: 2019


In September 2019, Malaysia halal medical device standard is published, known as:

MS 2636 : 2019 Halal Medical Device - General Requirements.

This MS 2636 standard is a voluntary basis and a value added guidelines to the industry to serve the users requiring halal affirmation. Standards Malaysia, strongly urge industry players who are interested in certifying their products to refer to JAKIM as it provides opportunities for any company to venture into Halal markets, including the Middle East, Japan and Indonesia.

This standard refers to halal medical device that based on organic material, chemical and biological that from animal origin. This new standard specifies the requirements in the manufacturing and handling of medical devices and covers products such as:

  • surgical mesh

  • contact lens

  • dental floss

  • dialysis solution

  • haemodialysis solution

  • water injection

  • suture

  • humidifier,

  • wound wash

  • eye lubricant

  • bone graft

Medical Device Act 737 does not require product to be halal. All registered medical devices may be placed in the Malaysian market without halal certification. However, medical devices need to comply with Act 737 before it can be certified halal.

Existing halal product - Eye drops and haemodialysis solutions classified as pharmaceuticals were certified to MS 2424: 2012 – Halal Pharmaceuticals by JAKIM. However, these products are now categorised as medical devices under Medical Device Act 2012. These halal certificates are no longer valid after their expiry

New halal product - There are new request from companies for halal certification to certify medical devices such as the synthetic bone graft. Halal certification will help to resolve problem to export and market this product in the Halal recognised countries.

The first Awareness Seminar on MS 2636 in November 2019 was officiated by Mr. Shaharul Sadri Alwi, Senior Director of Standards Malaysia in the presence of YBhg. Datuk Zamane Abdul Rahman as a Chairman of Working Group on Halal Medical Device, YBhg. Brig. Gen. Dato A Halim from Ministry of Defence, Ustaz Johari from Department of Islamic Development Malaysia (JAKIM) and Mr. Amrahi Buang from Malaysian Pharmaceuticals Society.

Other Malaysia standards for healthcare products

  • MS 2424: 2019 Halal Pharmaceuticals - General requirements

  • MS 2634: 2019 Halal cosmetics - General requirements

  • MS 1500: 2019 Halal Food - General requirements

  • SIRI MS 2400: 2019 Halal Supply Chain - General requirements

Other Indonesia Halal news

On 17 October 2019, Indonesia implemented the halal requirements and transition period for different healthcare products are covered in previous ARQon news page.

Source: Malaysia Standard, Global Halal Summit

Contact ARQon at info@arqon.com


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