Malaysia: Control of Orphaned, Obsolete and Discontinued Medical Devices

obsolete

The Medical Devices Authority (MDA), Malaysia anticipated the presence of orphaned, obsolete and discontinued medical devices in hospitals or healthcare facilities that were not registered under the Medical Devices Act. Therefore, a policy has been introduced to address this group of devices.

The Medical Device Authority (MDA) of Malaysia recent;y released Circular Letter No.2 Year 2018 relating to the control of orphaned, obsolete and discontinued medical devices in hospitals or healthcare facilities in Malaysia.

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2018-10-24T14:38:20+08:00 June 28th, 2018|News & Events|

Singapore: Regulatory guidelines for devices used for aesthetic purposes

aesthetic

The Health Sciences Authority, Singapore has issued guidelines for devices that are used for the modification of appearance or anatomy (aesthetic purposes) and regulated as medical devices. In addition, the HSA has provided information on its regulatory approach and the regulatory requirement for these devices.

The Health Sciences Authority (HSA) has issued guidelines to clarify the regulatory requirements associated with devices used for the modification of appearance or anatomy (aesthetic purposes) that are regulated as medical devices. Such devices include any instrument, apparatus, implement, machine or appliance intended to be used on humans for the restoration, improvement or modification of physical appearance.

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2018-10-24T14:39:14+08:00 June 28th, 2018|News & Events|

Vietnam: Evaluation After 2 Years of Decree 36/2016/ND-CP Implementation and Postponement Announcement

HIV

After 2 years of implementation and deployment, Decree 36/2016/ND-CP has established a solid foundation and a sound legal framework to unify the medical device industry and encourage international interest in the region. While there are many advantages of Decree 36/2016/ND-CP, there are still challenges facing its implementation.

Decree 36/2016 / ND-CP is a document issued in Vietnam to unify virtually all aspects related to medical equipment, from production and clinical trials, through to circulation, traceability, trading, inspection, export, and import.

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2018-10-24T14:40:26+08:00 June 28th, 2018|News & Events|

Indonesia: Procurement of medical devices and pharmaceuticals for Government hospitals

government

Following the issuance of Presidential Regulation Number 16, 2018,  there are now five different methods that can be used to procure medical devices and pharmaceutical products for government hospitals.

In Indonesia, the e-catalogue is one of the methods that can be used to procure goods and/or services for the government, including the procurement of medical devices and pharmaceutical products for government hospitals. However, following the issuance of Presidential Regulation Number 16, 2018,  there are now five different methods that can be used:

1) Public Auction / e-purchasing / e-catalogue
2) Quick Tender
3) Tender
4) Direct Appointment
5) Direct Procurement

The issuance of this new regulation demonstrates that the procurement process is now more flexible than it was previously where procurement was exclusively undertaken using the e-catalogue method.

2018-07-03T07:51:23+08:00 June 28th, 2018|News & Events|