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China, Medical Device Regulations. What do you need to know?

February 20, 2020

National Medical Products Administration (NMPA) is in charge of all pharmaceuticals and medical device regulations in China.

Medical devices are being classified into 3 classes. All according to their potential risks. Class I (Lowest), Class II (Middle) & Class III (Highest).

A further breakdown in the specifics of the 3 classes;

Class I – All devices in which safety and effectiveness can be assured through routine administration.

Class II – All devices involving further controls and monitoring in order to ensure safety and effectiveness.

Class III –All devices used for life support or sustenance, which might be a potential threat to health or relating to any implants into the human body.

If a medical device not manufactured in China wants to be registered in the Chinese market, device samples are required to be sent to NMPA for testing.

All product information on both packaging and labeling must be translated to Simplified Chinese.

The Medical device registration validity is 5 years. If a renewal should be required, the application should be submitted 6 months in advance before the expiry date.

Foreign manufacturers and brands must hire China-based agents to represent their brand in the Chinese market.

Japan, Changes to medical device regulations. What you need to know?

February 13, 2020

An official announcement was made in regards to the adoption of a new version of the Pharmaceuticals and Medical Devices (PMD) Act.

The latest version of the PMD Act covers issues such as

  • Application of Artificial Intelligence
  • Unique Device Identifiers
  • Instructions For Use provided in electronic form

There were also changes made to the requirements relating to pre-marketing application submission and post-marketing surveillance.

The goals of this new change are,

  • Simplification of access to the market to make innovative medical devices accessible to patients.
  • Providing a new vision on the functions of healthcare institutions and professionals.
  • Improvement of the regulatory compliance system.

We would see drastic improvements in compliance and supervision systems.

Thus, making communications with manufacturers more efficient through providing legal clarity and certainty of the regulatory requirements.

Indonesia, Directorate of Assessment providing assurance for medical devices and healthy products.

February 6, 2020

Directorate of Assessment Indonesia is providing an assurance for medical devices and household health supplies distributed.

Before products enter the market for distribution all medical devices and household health supplies must attain a marketing authorization number.

This is to ensure that the product quality, safety and efficacy requirements are met. Additionally, providing legal certainty and a healthy business environment. Alongside providing public assurance in the products they use.

This initiative would be done in 4 simple steps.

Step 1: Product Testing

Tests would be done to the product to identify and check for quality and safety requirements and to ensure product consistency and also detect the presence of fake or illegal products.

Step 2: Label Controls

To prevent misleading information from being included. Also ensure that advertising and labeling are objectives, ethical and not include any misleading information or language.

Step 3: Vigilance System Supervision

To prevent the recurrence of the same event and to correct any unexpected event which can potentially still occur even the product has passed its assessment. Such as serious injury, death or deterioration in the health of the patient.

Step 4: Clinical and Technical Information Audit

This activity is under the MoH Directorate Surveillance roles & duties.

UK, BREXIT it’s Official. What’s Next ?

February 3, 2020

UK, As the clock, strikes midnight on 31st January 2020.

The UK would have officially left the European Union and enter a transition period till 31st December 2020.

During this period, the UK will remain in the EU’s customs union and single market and all rights alongside all obligations of companies and citizens will not be affected.

Further negotiations will be taking place for future trade conditions.

These outcomes remain unclear and can range from a Free Trade Agreement/Mutual Recognition Agreement to the UK dealing with the EU on WTO terms.

But, the UK will not be a member if EU institutional organizations.

MHRA and EU institutions will be updating their guidelines reflecting the outcomes via their website.

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

Indonesia, Exemption from Import Duties for Health Services Goods

January 23, 2020

The importation of health goods in Indonesia are normally subjected to a fiscal levy through customs duties and taxes in the framework of import (PDRI).

The importation of items are divided into 2, purchase and grant goods. They are normally subjected to fiscal levy through customs duties and taxes in the framework of import (PDRI). Which is likely to cause an increase in prices for imported goods.

To achieve savings and efficiency, the importation of health goods can be provided with fiscal facilities through the exemption of import duties and import taxes (PDRI).

It is very important to be able to distinguish the difference between the subject (recipient of goods), the object (the type of goods) and the allocation of the intended goods. As exemptions of import duties may differ.

This is being done in accordance with Article 25 and 26 of Law No. 17 of 2006 concerning The Amendment of Law No.10 of 1995 on customs.

During the process of issuing goods at the port, do take note of the costs that might arise such as warehouse rental, handling, etc.

Even after the goods are released and cleared, the importer or the receiver has to comply with the provisions set forth in the letter “Decision on Import Duty Exemption” to ensure a proper process.

USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.

January 20, 2020

USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.

Upcoming in the later part of 2020, we will see them move from a paper-based process to a new cloud-based online submission portal for orphan drug designation requests.

This new initiative would ease the process of making orphan drug designation requests, which are currently being physically mailed to the Office of Orphan Products Development (OOPD) on a CD.

Allowing an even connected information technology system alongside, advanced analytics and improvements in facilitating knowledge management.

Additionally providing external sponsors with an even more efficient submission of documents and enhanced direct communication directly with the FDA.

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Looking at importing into The Philippines? What you need to take note?

January 16, 2020

Importing into the Philippines is pretty a straight forward process.

Provided the guidelines provided by the Bureau of Customs are adhered to.

Goods entering the Philippines’ territories are either regulated, restricted or prohibited due to domestic reasons.

They are classified under the following 4 classes;

  • Free Importation and Exportation
  • Regulated Importation and Exportation
  • Restricted Importation and Exportation
  • Prohibited Importation and Exportation

Hardcopy of Single Administrative Document (SAD) signed  the declarant and customs broker must be submitted to the Formal Entry Division (FED) alongside,

  • Commercial Invoice.
  • Packing List.
  • Duly notarized Supplemental Declaration on Valuation.
  • Duly endorsed Bill of Landing or Airway Bill.
  • All documents that may be required by specific rules and regulations.

Goods declaration must be lodged within 15 days from the date of discharge of the last package from the vessel or aircraft.

Goods imported into the Philippines are subject to duty and taxes upon importation.

Importation would begin when vessel or aircraft enters Philippine’s territories with the intention to unload therein.

 

Ministry of Health, Vietnam regulations on the management of medical equipment

January 13, 2020

Vietnam, Ministry of Health (Department of Medical Equipment and Construction) had a Business Dialogue Conference in regard to regulations on the management of medical equipment.

Here are some highlights on what has transpired,

  1. Import license validity is till 31st December 2021 for Class B, C, D medical devices for all import licenses issued in 2018 (valid till 31st December 2018) and on import licenses issued in 2019.
  2. For Class B, C, D medical devices which don’t require an import license, importation can continue as normal until 31st December 2021 without a Confirmation Letter from the Ministry of Health, Vietnam.
  3. Vietnam is extending of application of CSDT format until 1st January 2022.

Every registrant should be clear and understand the medical devices and the regulations that are registered.

More details are in the link on the first comment.

www.dmec.moh.gov.vn

Malaysia, Medical Devices advertising? Here’s what you need to know

January 9, 2020

As of Medical Device (Advertising) Regulations, no advertisement of any registered medical device can be done without the approval from the Ministry of Health Malaysia.

In order to make an advertisement an application for an approval to advertise a registered medical device must be submitted to the Ministry of Health Malaysia in writing accompanied by specific documents.

This regulation will come into full effect starting from 1st July 2020.

Anyone found guilty of breaching this regulation shall be liable to a fine not exceeding RM 200,000 or imprisonment for a term not exceeding 2 years or to both.

To facilitate a smooth process for an approval to advertise a registered medical device.

The following documents and steps are required,

  • Copy of advertisement plan of the medical device.
  • Processing fee of RM 1,000.
  • Letter of appointment from the origin of the medical device which it was registered.

Alongside the following 2 pointers to be included in the advertisement.

  • A certificate that the medical device is registered under the Act.
  • Registration number assigned to the registered medical device by the Authorities.

World Health Organization first bio-similar pre-qualification

January 7, 2020

WHO (World Health Organization), pre qualified their first bio-similar.

This newly pre qualified medicine is Samsung Bioepis’ Ontruzant which is a bio-similar version of trastuzumab.

After assessment WHO stated that this product is comparable to its originator in terms of efficacy, safety and quality. Thus, making it eligible for procurement by many national health systems and United Nations agencies.

This would see the alleviation of inaccessible treatment and high cost of medicines for many in poor countries.

Providing affordable breast cancer treatment for all women.

The cost of this new pre qualified medicine would be 65% lower than Rituxan making it affordable for many healthcare systems in developing countries.