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REGULATORY UPDATE | Changes In Registration Fees For Health Products
The Health Sciences Authority (HSA) has implemented new registration fees to ensure that health products meet established standards of quality, safety, and efficacy. These fees are designed to help cover the costs associated with registration, licensing, notifications, and the issuance of permits for various products, including therapeutic products, medical devices, Chinese-manufactured drugs, cosmetics, cellular networks, gene therapy, oral gum products, and retail pharmacies.
Starting July 1, 2024, there will be a change in fees, with an increase of approximately 5%. The minimum increase will be $1, while the maximum increase per item will be $200. This adjustment is necessary to recover a portion of the service costs provided to businesses.
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Our Services
- License Representative
- Product Registration
- Medical Device Company Establishment Service
- Renewal and License Amendment
- Miscellaneous Certificates
- Post-Marketing Surveillance
- E- Catalogue
- Medical Device Trademark Management
- GDPMD (Good Distribution Practice for Medical Device)
- Regulatory Intelligence
- IDAK (Izin Distributor Alat Kesehatan)