Medical Device (Advertising) Regulations in Malaysia

advertising

According to the Medical Device (Advertising) Regulations 2019, no person shall advertise any registered medical device without prior approval from the relevant Authority. Any application for approval to advertise a registered medical device must be made to the Authority with the specified documents.

On the 3rd of September 2019, the Malaysian Ministry of Health released a regulation regarding the advertisement of medical devices in Malaysia. This regulation will come into full effect from the 1st of July 2020. The Medical Device (Advertising) Regulations 2019 states that no person shall advertise any registered medical device without approval from the Authority. Any person who commits an offence may be liable to a fine of up to two hundred thousand ringgit or imprisonment for a term not exceeding two years or could be subject to both fine and imprisonment.

An application for an approval to advertise a registered medical device shall be made to the Authority in writing with the following documents:

• a copy of the proposed advertisement for the registered medical device
• a processing fee of one thousand ringgit
• a letter of appointment from the establishment to whom the medical device is registered (if the application is appointed)
The following shall be listed on the advertisement:
• a certificate that the medical device is registered under the Act
• the registration number assigned to the registered medical device

2020-01-13T09:14:09+08:00 December 29th, 2019|Medical Regulation Updates, News & Events|

Vietnam: Business Dialogue Conference on Management of Medical Equipment Regulations

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The Ministry of Health, Vietnam has shared with attendees of a business dialogue that the validity of import licenses and the effective date for product licenses Class B, C and D will be extended. The official announcement has been published on the government website..

The Ministry of Health (Department of Medical Equipment and Construction), Vietnam organized a business dialogue conference (3rd of Dec 2019 in Hanoi and on the 14th of Dec 2019 in Ho Chi Minh city) focussing on the regulations of the management of medical equipment and asked for comments on policies supporting the development of domestic production of medical equipment.

The general guidelines about import licenses and product licenses are:
• The import license is valid until 31st of December 2021 for Class B, C, D medical devices for all import licenses issued in 2018 (valid on 31 December 2018) and all import licenses issued in 2019.
• For Class B, C, D medical devices that do not require an import license, importation can continue as normal until 31st of December 2021 without the requirement for a Confirmation Letter from the Vietnamese Ministry of Health.
• Vietnam will apply the Common Submission Dossier Template format until the 1st of January 2022.

In conclusion, the Ministry of Health will expand the valid date for import licenses until the 31st of December 2021 and, the effective date of product licenses for the next two years (1st of January 2022). Every registrant should understand the medical devices that are being registered and the regulations surrounding these.

The new decree is released to public early this month, January 2020. For further information, please refer to the following website: www.dmec.moh.gov.vn

2020-01-13T11:34:42+08:00 December 29th, 2019|Event, Insight, Medical Regulation Updates, News & Events|

Indonesia: Exemption from Import Duty for Health Services Goods

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The import of health goods will normally be subject to a fiscal levy through customs duties and taxes in the framework of import (PDRI). Certain health goods may be exempt of import duties and taxes via the import duty exemption scheme

Goods for health services can be sourced domestically or internationally. Importation of such items can be divided into two: goods obtained from the purchase, and grant goods. The import of health goods will normally be subject to fiscal levy through customs duties and taxes in the framework of import (PDRI). This is likely to increase the price of imported goods. For savings and efficiency, the import of health goods can be provided with fiscal facilities through the exemption of import duties and import taxes (PDRI).

IMPORT DUTY EXEMPTION SCHEME
The procedure for the exemption of import duties for medical goods can differ from one party to another. It is important to distinguish the difference in the subject (recipient of goods), object (type of goods) and the allocation of the intended goods.
In accordance to Article 25 and 26 of Law No. 17 of 2006 concerning The Amendment of Law No.10 of 1995 on customs, health goods can be granted a Customs Exemption Sign using the scheme below:
a. Goods for charity and social purposes;
b. Goods for the sake of natural disaster management.
c. Goods for research and development of Science;
d. Goods for the need of disability;
e. Goods for the Central Government or Local government for public interest.
f. Goods for the need of government projects financed by loans and/or grants from abroad

COSTS INCURRED DURING THE PROCESS OF ISSUING GOODS (CLEARANCE)
In the process of issuing goods from the port, it is possible that costs associated with warehouse rental, handling, etc. may arise. Although the recipient of the goods has obtained the exemption from import duty and PDRI, the exemption is not related to these costs incurred in the process of issuing the goods and cannot be waived . The recipient can anticipate this cost by confirming the carrier and the designated customs broker, PPJK.

AFTER THE GOODS EXIT THE PORT
After the goods are released from the port by obtaining import duty exemption and PDRI, the importer or the receiver still has an obligation to comply with the provisions set forth in the letter ‘Decision on import duty Exemption’. Conditions that the recipient must comply with:
a. The recipient must use the goods in accordance with the provisions specified in the exemption decree of import duty.
b. The goods are not transferable to another party, except with the permission of the Directorate General of Customs and Excise. This is mainly used for items that are not consumables. In the event that the goods are used or intended to be shared (consumed or worn) to the prescribed party, then the handover does not require permission from Directorate General of Customs and Excise (DGCE)
c. The DGCE will conduct monitoring and evaluation for those goods that receive exemption from import duty. In this monitoring and evaluation, the recipient of the goods must be able to show related documents and/or the existence of imported goods.
d. DGCE may also conduct customs audits of importation of goods that obtain Exemption of import duty.

2020-01-13T09:36:12+08:00 December 29th, 2019|Insight, News & Events|

Classification of Medical Devices and In Vitro Diagnostic Devices in India

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Medical devices and in vitro diagnostic devices are classified according to the intended use of the device, risks associated with the device, and other parameters specified in the First Schedule

Historically there has been minimal regulation of medical devices in India. However, the medical device industry has changed with the Medical Devices Rules 2017, For the regulation of medical devices with respect to import, manufacturing, clinical investigation, sales and distribution, the Central Government (in consultation with the Drugs Technical Advisory Board) has developed the Medical Devices Rules 2017. This came into effect from the 1st of January 2018 under the provisions of the Drug and Cosmetics Act 1940. The safety and performance of medical devices and in vitro diagnostic devices are regulated under this Act.

Medical devices and in vitro diagnostic devices are classified based on the intended use of the device, risks associated with the device and other parameters specified in the First Schedule. Based on these factors, devices have been categorised into risk classes under the provisions of sub-rule (I), Rule 4 of the Medical Devices Rules 2017. A total of 350 categories of medical devices and 247 categories of in-vitro diagnostic devices have been classified in accordance with the amended Annexure I as of the 6th of June 2018.

Recently, on the 15th of May 2019, further classification of 12 newly notified medical devices have been added to the existing list of classified devices. All these newly notified device types have been assigned moderate to moderate-high Class B and Class C risk classifications:
• CT scan equipment (Class C)
• MRI equipment (Class C)
• Defibrillators (Class C)
• Dialysis machines (Class C)
• PET equipment (Class C)
• X-ray machines (Class C)
• Bone marrow cell separators (Class B)
• Nebulizers (Class C)
• Blood pressure monitoring devices (Class B)
• Digital thermometers (Class B)
• Glucometers (Class C IVD)
• Organ preservation solutions (Class C)

These classifications will come into effect from the 1st of April 2020. These risk classifications will allow the industry to get a better idea of the costs involved, clinical data requirements (if any) and the import licensing authority as they commercialize their products in India.

2020-01-13T09:42:38+08:00 December 29th, 2019|Event, Insight, News & Events|

Andaman Medical Expanding Its Footprint in Asia

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Are you looking into seizing an opportunity in India’s medical device market? Andaman Medical India is commencing its operation in 2020. We are excited to assist you in regulatory matters and contribute to your business development in India. We will be sharing more on our new division soon.

India is the fourth largest medical device market in Asia after Japan, China and South Korea. The current medical device market size is estimated to be worth USD 5.2 billion, with projections that India will become the world’s most populous nation by 2024, with a medical device market size between USD 9.3bn to 10.8bn. This provides an opportunity to help to shape the Indian medical device market and to enhance the quality of life of those living in India.

Andaman Medical may be able to help you to seize this opportunity. From 2020, Andaman Medical will expand its footprint in India. We aim to assist you in navigating the complex regulatory requirements by being the local license holder, facilitating registration processes with authorities, providing regulatory intelligence work and business development services.

For medical device regulations in India, the regulatory body responsible for medical device registration is the Central Drug Standards Control Organization (CDSCO). Only notified medical devices shall undergo registration with CDSCO. Currently, there are about 30 medical device product families that require registration. For example, disposable hypodermic needles, catheters, drug eluting stents and bone cements require registration with CDSCO. By the 1st of April 2020, blood pressure monitoring devices, CT scanning equipment, MRI equipment, defibrillators and dialysis machines are some of the devices that are scheduled for regulation.

We look forward to sharing more information on Indian regulatory updates and news of Andaman Medical India.

Andaman Team India

2020-01-13T09:46:56+08:00 December 6th, 2019|Event, Insight, News & Events|