Purpose of Harmonised Borderline Products and Classification in ASEAN

The goal of these Harmonised Borderline Products and classification in ASEAN is to ensure that the products are regulated under a harmonized regulatory framework, thereby facilitating easier entry into the ASEAN market. Whether a product is classified as a medical device or non-medical device is determined based on its intended purpose as specified by the manufacturer.

In Malaysia, MDA adopts a risk-based system that follows the ASEAN Medical Device Directive (AMDD) as stated in the First Schedule of the Medical Device Regulations 2012. These devices are categorized into Class A, B, C and D based on their level of risk.

Newly Classified Products in MDA/GD/0063 Guidance Document

The latest edition of the guidance document MDA/GD/0063 includes the addition of 6 new products from the 13th and 14th ASEAN Medical Device Technical Committee (AMDTC). The newly added products classified as medical devices are:

1. Nasal spray for nasal cleaning with deep sea salt water
2. Wound cover gel or cream containing hyaluronic acid or sodium hyaluronate for treating wounds and burns
3. Reverse osmosis equipment used in hemodialysis water treatment systems
4. Dermal implant used for treatment of facial contour deformities
5. Nitric oxide nasal spray

Meanwhile, sprays and creams intended to help prolong sexual intercourse but without pharmaceutical ingredients are classified as non-medical.

Device Variations Added in MDA/GD/0062 Guidance Document

Similarly, the latest edition of MDA/GD/0062 includes variations of newly added medical devices with different classifications from the 13th and 14th AMDTC. These newly added devices include:

1. Ear, nose and throat devices
2. Gastroenterology-urology devices
3. Clinical chemistry and clinical toxicology devices
4. Hematology and pathology devices
5. Anesthesiology devices
6. Cardiovascular devices
7. Neurological devices
8. General and plastic surgery devices
9. Immunology and microbiology devices
10. General hospital and personal use devices

Recommendation for Ongoing Compliance

These guidance documents will be revised annually to incorporate the latest decisions made by the ASEAN Medical Device Committee (AMDC). Therefore, establishments are advised to review these updates regularly to ensure product classification complies with ASEAN regulatory requirements.

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