Monthly Archives: February 2018

The Medical Device Authority of Malaysia will be hosting the Malaysia Medical Device Expo 2018 (MYMEDEX 2018), which will be held from 18th – 20th April 2018 at the Putra World Trade Centre.  This event is supported by the Ministry of Health of Malaysia.

The Malaysia Medical Device Expo 2018 is an initiative to showcase the latest innovative technologies and advances in global medical devices. The aim is to create an insightful one-stop centre for medical device solutions as this is one of the largest industries in global healthcare. This expo will ensure the advancement of healthcare and also provide knowledge on the latest devices.

The authority would like to create opportunities to extend its network in this industry, as well as providing a platform to meet potential buyers or partners to find the latest fitness, healthcare and nutritional medical devices. Encouraged by the increasing demand and over-whelming growth of technology in the medical device industry, the Medical Device Authority was compelled to organize this expo to exhibit the latest innovations in the industry to healthcare personnel.

This event will showcase various global companies and exhibit their latest medical devices and healthcare services in order to foster future innovative medical solutions. It targets over 10,000 visitors, 300 exhibitors, entrepreneurs, business leaders, investors and involves government agencies, multinational companies and government-led companies.

For more information, visit www.mymedex.com.my

The VAT (Value Added Tax) Administration for Medical Devices in Vietnam is managed by the Ministry of Health in order to implement the new regulation on management of medical devices (Decree 36/2016/ND-CP). The Ministry of Health of Vietnam – Department of Medical Equipment and Construction has unified with General Customs Department for the rate of VAT applied to medical devices.

While waiting for the Ministry of Finance to revise the regulation, the Ministry of Health decided to apply the VAT rate of 5% to medical devices, in accordance with Circular 65/2017/TT-BTC published on 27 June 2017 by the Ministry of Finance:
a) In the transitional period:
The classification of a product as a medical device is based on Clause 8, Art 1, Circular 26/2015/TT-BTC published on 27 February 2015 by the Ministry of Finance.

“11. Medical equipment includes machinery and instruments serving healthcare such as: radiographic equipment serving medical examination and treatment, equipment and instruments for surgery and injury treatment; ambulances; instruments for blood pressure measurement, cardiography, blood infusion, syringes; birth control equipment, and other medical equipment certified by the Ministry of Health.

Cotton wool, bandages, gauze pads, and medical tampons; medicines including finished medicines and raw materials, except for functional foods; vaccines; bioproducts, distilled water to mix with injectable medicines or intravenous fluids; caps, clothing, facemasks, gloves, boots, medical towels, breast implants and skin fillers (not including cosmetics); chemicals used for testing and sterilization.”

And medical devices with import licenses issued in accordance with Circular 30/2015/TT-BYT on 12 October 2015.

In the case that a medical device does not belong to any of the classifications listed above, they will be classified based on the standard medical device classifications.

b) From the date of notification of the applicable standard (Class A) and product license (Class B, C, D) comes into effect, a medical device is classified based on the product license. In cases where accessories or spare parts are not medical devices or are not classified as medical devices as per Decree 36, the customs department could accept customs clearance for a shipment if it is not declared as a medical device by the importers.

The Ministry of Health of Indonesia has recently issued Ministerial Regulation No. 61 of 2017 in relation to Medical Devices, In Vitro Diagnostics, and Household Healthcare Licensing. This is to replace the previous Ministerial Regulation No. 1190 of 2010 in relation to Medical Device and Household Healthcare Licensing. The implementation started in January and is expected to be fully applied by the middle of the year.

Changes to be expected:
1. Accelerated registration timeline
2. Incremental registration fees (to be updated)
3. Electronic ministerial signature on product approval
4. Self-assessed classification

Previously, medical device registration in Indonesia could take about 6-8 months. Now, the authority has sped up the process to just 1-2 months between application and approval. The accelerated timeline is also applied for change and renewal registration. Implementing electronic signatures on product approval is also one method used by the authority to accelerate medical device registration. There is no need for wet stamps and signatures by the Minister herself, which previously caused delays to the process.

Another impact of the update is that the manufacturer must become more responsive, as the deadline for an enquiry has being reduced to 10 calendar days. The RA representative must also be thorough and careful when doing product classification because the authority will no longer help the applicant to classify the products. Overall, this is a very efficient and beneficial regulatory update for all parties, especially manufacturers who are looking to distribute their products in Indonesia.

Medtec Japan is one of the highly acknowledged events for the medical device industry. It is a unique platform that brings together all the leading manufacturers of innovative medical technologies. It is the largest of its kind in Asia and there will be conferences and seminars with discussion forums and interactive platforms where major issues relating to the manufacture and design of medical products are discussed.

This year, Medtec Japan will be held from 18th to 20th April 2018 in Tokyo, Japan. Andaman Medical will be participating in the event and we look forward to further discussing with you the opportunities in Japan as well as the pathway to bring your devices to South East Asia.

For more info: http://www.medtecjapan.com/en