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

business dialogue

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|

Philippines: A Review of the Importation System, Requirements and Documentation

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Importing into the Philippines is straight forward with the guidelines provided by the Bureau of Customs. We explain the importation classifications and the basic requirements for importation.

The importation of certain commodities into the Philippines is either regulated, restricted or prohibited for reasons of public health and safety, national security, international commitments and development/rationalization of local industry. Imports are classified into the following:

  • Free Importation and Exportation – refers to goods that may be freely imported into and exported from the Philippines without the need for import and export permits, clearances or licenses (unless otherwise provided by law or regulation). (Chapter 3, Section 116 Customs Modernization and Tariff Act [CMTA])
  • Regulated Importation and Exportation – goods which are subject to regulation can only be imported or exported after securing the necessary declaration, clearances, licenses, and any other requirements prior to importation. For importation, submission of requirements after arrival of the goods, but prior to release from customs custody, will only be allowed in cases provided for by governing laws or regulations (Chapter 3, Section 117 CMTA). Examples of regulated imports are: food, drugs, cosmetics and medical devices regulated by the Food and Drug Administration.
  • Restricted Importation and Exportation – except when authorized by law or regulation, the importation and exportation of restricted goods listed in Chapter 3, Section 119 of the CMTA are prohibited. Examples of restricted imports are habit forming chemicals/substances such as opium, marijuana, heroin and other narcotic and synthetic drugs.
  • Prohibited Importation and Exportation – the importation and exportation of goods listed in Chapter 3, Section 118 of the CMTA are prohibited. Examples of prohibited imports are adulterated or misbranded food, drug, cosmetics, devices or goods for human consumption in violation of relevant laws and regulations. The list of regulated Import Commodities and their Administering Agencies can be viewed in the Philippine National Trade Repository.

Documentation Required for Importation
The printout of the Single Administrative Document (SAD) signed by both the declarant and the customs broker(and if applicable, duly notarized), must be submitted to the Formal Entry Division (FED) or its equivalent office or unit, with the following documents:
1. Duly endorsed Bill of Landing or Airway Bill, or certification by the carrier or agent of the vessel or aircraft;
2. Commercial Invoice, Letter of Credit or any other verifiable commercial document evidencing payment. In cases where there is no sale for export, a commercial document indicating the commercial value of the goods is required;
3. Packing List
4. Duly notarized Supplemental Declaration on Valuation (SDV);
5. Documents that may be required by specific rules and regulations, such as:
1. Import Permit or Clearance (Ex. FDA LTO, CPR, NTC permit, DDB Exemption);
2. Authority to Release Imported Goods (ATRIG);
3. Proof of Origin for Free Trade Agreements (FTAs);
4. Copy of an Advance Ruling, if the ruling was used in the goods declaration;
5. Load Port Survey Reports or Discharge Port Survey Reports for bulk or break bulk importations;
6. Document evidencing exemption from duties and taxes;
7. Others, e.g., Tax Credit Certificate (TCC) or Tax Debit Memo (TDM).

Lodgement of Goods Declarations.
Those authorized to lodge a goods declaration or make an import entry are as follows:
a) The importer, being the holder of the bill of landing or airway bill. If the importer is a juridical person, they may authorize a responsible officer of the company to sign the goods declaration on their behalf. For a corporation, the responsible officer must be authorized by the Board of Directors to sign as the declarant on its behalf. For a partnership, the responsible officer must be authorized by the partners. For sole proprietorship, the responsible officer must be authorized by the owner, who shall issue a Special Power of Attorney (SPA).
b) A customs broker acting under the authority of the importer or holder of the bill; or
c) A person duly empowered to act as agent or attorney-in-fact for each holder of the bill. The duly notarized power of attorney should be approved by the Port Collector. No more than signing power may be accepted.

Period Within Which to Lodge.
A goods declaration must be lodged within (15) days from the date of discharge of the last package from the vessel or aircraft. The period to lodge the goods declaration may upon request, be extended on valid grounds for another fifteen (15) days subject to the approval of the District Collector. The request must be made before the expiration of the original period to lodge the goods declaration. The period for lodgement of the goods declaration may be adjusted by the Commissioner.

Goods Liable to Duties and Taxes.
All goods, when imported into the Philippines, shall be subject to duty upon importation. These include goods previously exported from the Philippines, except for the following:

  • Those that are conditionally tax and/or duty-exempt importations under section 800, Chapter 1, Title VIII of the CMTA;
  • Those considered as De Minimis importations;
  • Importations of books under the Florence Agreement;
  • Other tax privileges granted by law;
  • Importations under the Customs Bonded Warehousing Systems; and
  • Importations intended for free port zones.

When Importation Begins and when it is deemed Terminated.
Importation begins when the carrying vessel or aircraft enters the Philippine Territory with the intention to unload therein. Importation is deemed to be terminated when:

  • The duties, taxes and other charges have been paid or secured to be paid at the port of entry (unless the goods are free from duties, taxes and other charges and legal permit for withdrawal has been granted); or
  • If the goods are deemed free of duties, taxes and other charges, they have legally left the jurisdiction of the Bureau.
    Selectivity System. Determines the selection of examination procedures based on risk criteria established in the Customs Cargo Clearance System. The Customs Cargo Clearance System assigns the declared goods to one of the following control channels:
  • Red lane – documentary check; and physical examination or non-intrusive inspection, or magna scale weighing (when necessary);
  • Yellow lane – documentary check;
  • Blue lane – to be considered for post clearance audit; or
  • Green lane – released without documentary check and without examination of the goods.

References:
https://www.dti.gov.ph/business/imports/import-facilitation

2019-12-29T17:58:12+08:00 November 27th, 2019|Insight, News & Events|

Indonesia: Government Regulation PP No. 64 of 2019 on the Change of Tariffs on Registration Renewal

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The Ministry of Health Indonesia has implemented a new tariff on medical device registration renewal with amendment. This new tariff was enacted on the 17th October 2019 after regulation PP No. 64 of 2019 was released.

The Indonesia government has issued a new regulation namely PP No. 64 of 2019 concerning Types and Rates of Non-Tax State Revenues that apply to the Ministry of Health (MoH), which was previously regulated in PP No. 21 of 2013. This new regulation was promulgated on 17 September 2019, and it start implemented 30 days after promulgated, that’s mean since 17 October 2019.
This change of tariff already Socialize by MoH to all distributors in Indonesia. Socialization held by MoH more focused on the information about the change tariff for the Renewal with Amendment.

Below is the tariff changes information.
1. The services of Medical Devices Marketing Authorization

*) PP PNBP No. 21 of 2013: there is an increase of IDR 500,000 for Renewal with Amendment

2. The services of Household Health Supplies (PKRT) Marketing Authorization

*) PP PNBP No. 21 of 2013: there is an increase of IDR 500,000 for Renewal with Amendment

Criteria of change notification or amendment of medical device are as follows:
1. Size
Including addition or reduction of product content and/or size

2. Packaging, including
– Increase or decrease of packaging size
– Addition or reduction of packaging types
– Design change in package shape
– Changes in packaging material

3. Marking
– Language changes in the instructions for use (instructions for use) and/or packaging
– Changes to the logo or symbol, including the halal logo, quality management system, CE, and company logo.
– Changes to product expiration date if stated in the designation
– Changes to product code/type
– Changes in storage temperature
– Improvements to the product name
– Designation of designation markings (color, image, text and layout)1. Size, including:
– Addition or reduction of product content and/or size

4. Accessories/attachments on marketing authorization:
– Accessories
– Type
– Product code
– Product Size

5. Name and/or address of the representative authorized by the Manufacturer, including:
– Change in the name and/or legal address of the manufacturer
– Change in legal entity
– Change in manufacturer’s address due to changes in urban planning
– Change the manufacturer’s name as long as the manufacturer’s address does not move/ change the location
– Change the name of the distributor if the Tax ID Number (NPWP) and business permit number (NIB) do not change
– Change of address of the distributor who moved the province

6. Writing on marketing authorization (typo)

Criteria of change notification or amendment of PKRT device are as follows:
1. Size (for certain products)
2. Packaging
3. Marking
4. Principal’s name and/or address that is not an acquisition, without a change in manufacturer’s name, for imported PKRT.
5. Other changes that do not affect PKRT’s specifications and claims

2019-12-03T04:58:19+08:00 November 26th, 2019|Insight, Medical Regulation Updates, News & Events|

Medical Device-Drug Combination Product Registration in Malaysia

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A guideline for the registration of drug-medical device and medical device-drug combination products has been released and was fully implemented in Malaysia on 1st July 2019. This article focuses only on Medical Device-Drug Combination Products (MDDCP).

On the 20th June 2019, a guideline for the registration of drug-medical device and medical device-drug combination products was released. This guideline was fully implemented on the 1st July 2019. This article focuses only on Medical Device-Drug Combination Products (MDDCP). MDDCP is where the primary mode of action on the human body is not based on pharmacological, immunological or metabolic means, but is assisted by the device to the extent that the Medical

The Medical Device Authority (MDA) is the primary agency of the combination product. All medical devices with substances incorporated, that when used on their own could be considered a medical product, must comply with this regulation. All medical devices that fall under Class D, Rule 13 of the Medical Device Regulations 2012 shall conform to this new directive.

Some examples of medical devices that fall under this section include but are not limited to soft tissue filler or dermal filler that incorporates local anesthetic, synthetic fluid tissue reconstructive material that incorporates a pharmacologically active substance, root canal filling incorporating antibiotics, drug-eluting stents, drug-eluting beads, general-body orifice lubricant incorporating local anesthetic and enteral feeding kits that contain an iodine pack drug.

For a medical device-drug combination product registration, where the MDA acts as the primary agency, the registration process shall undergo 3 stages:
• Stage 1 – Obtaining Endorsement from the National Pharmaceutical Regulatory Agency (NPRA)
• Stage 2 – Obtaining Certificate from the Conformity Assessment Body (CAB)
• Stage 3 – Application for Registration to the Medical Device Authority (MDA)

Stage 1 – Obtaining Endorsement from the NPRA
Applicant shall submit the following documents to the NPRA manually:
1. Application form for Endorsement Letter of Ancillary Component for Registration of Combination Product (Appendix 3)
2. Ancillary Drug Dossier (Appendix 2)
Note: for the specific labelling requirement, please refer to Appendix 9: Labelling Requirements, released by the NPRA.
Upon satisfactory evaluation, the NPRA shall issue an endorsement letter.

Stage 2 – Obtaining Certificate from the Conformity Assessment Body (CAB)
Applicants shall submit the documentation to the CAB. The CAB shall issue a certificate and report upon satisfactory conformity assessment.

Stage 3 – Application for Registration to MDA
Once the applicant has obtained the endorsement letter from the NPRA, certificate and report from the CAB, an application (in accordance with the Medical Device Regulation 2012) shall be made on Medcast 2.0 for the MDA to evaluate the medical device application. The MDA shall register the Medical Device-Drug combination product and issue a medical device registration certificate upon approval.

2019-12-03T05:22:33+08:00 November 25th, 2019|Event, Medical Regulation Updates, News & Events|

CT-MRI Society of the Philippines Conference

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Thousands attended the 2019 joint conference held by the CT-MRI Society of the Philippines and Ultrasound Society of the Philippines event to discuss scientific programs that involve new treatments, therapies, techniques, as well as new ground-breaking technology and innovation.

The CT-MRI Society of the Philippines and Ultrasound Society of the Philippines held its 2019 Joint Annual Convention with the theme “Basic and Advanced Imaging: Heading Down to Sound Decisions” on October 24-26, 2019 at the Manila Hotel’s Fiesta Pavilion. Thousands of radiologists, radiologic technologists, trainees from the government and private sector, as well as foreign delegates and speakers attended this event to discuss scientific programs that involve new treatments, therapies, techniques, as well as new ground-breaking technology and innovation.

The convention was sponsored by some of the notable medical device companies in the Philippines. In addition, exhibitors from the medical device industry that supply diagnostic imaging medical devices attended the 3-day event. Participant exhibitors showcased their products and took the opportunity to meet with their end-user clients and prospects to promote their products and services as well as create brand awareness.

2019-11-01T05:29:40+08:00 October 29th, 2019|Event, Insight, News & Events|