Abmed Medical Technology

Abmed Medical Technology Email: [email protected]

21/08/2024

Abmed global branch and business report! In response to the call of the "Belt and Road", keep up with current affairs, and help China's medical devices "go to sea"! （3）
4. Abmed Australia (including New Zealand), regular business
Functions: Australian sponsor, Australian clinical application for some products, FSC certificate application; Responsible for customs clearance, warehousing, logistics, after-sales and other duties.
The opening bank can accept a variety of foreign currencies (which are ultimately recorded in Australian dollars).

ABMED MEDICAL TECHNOLOGY PTY LTD

Address: 38 Omar Street Caulfield South VIC 3162

Australian Company Number 666767175

Tel: 00 61 432 758 222

Email: [email protected]

Contact: Mr. Boyle Wang

Account number 11699915

21/08/2024

Abmed global branch and business report! In response to the call of the "Belt and Road", keep up with current affairs, and help China's medical devices "go to sea"! （2）

2. Abmed EU, regular business, domiciled in Ireland
Functions: Odai (including medical devices, cosmetics, PPE products and various products needed for e-commerce), SRN/UDI registration, FSC certificate application; Can undertake the duties of importers, responsible for customs clearance, warehousing, logistics, after-sales and other responsibilities.
The bank can accept EUR, GBP, HKD, AUD.
Abmed Medical Technology Ltd.
Address: WorkHub, 51 Bracken Road, Sandyford Business Park, Dublin, D18 CV48, Ireland
Tel: +353 1902 6731
Email: [email protected]; [email protected]
European Union Agent, SRN: IE-AR-000043897
Eu Importer, SRN: IE-IM-000043898
Account number 0112993
BIC TRWIBEB1###

3. Abmed UK, regular business
Functions: English generation (including medical devices, cosmetics, ppe products and various products needed for e-commerce), SRN/UDI registration, fsc certificate application; MHRA registration, can undertake the duties of importers responsible for customs clearance, warehousing, logistics, after-sales and other duties.
Opening bank accepts GBP, EUR, USD.
Abmed Medical Technology Ltd.
Address: Floor 1, Office 25 22 Market Square, London, E14 6BU, UNITED KINGDOM

Tel: +44 203 355 1513

Email: [email protected]

Account number 26460329

SWIFT/BIC Code: WFSTGB2L

21/08/2024

Abmed global branch and business report! In response to the call of the "Belt and Road", keep up with current affairs, and help China's medical devices "go to sea"! （1）

Since the establishment of the company in 2008, Abmed has actively developed global medical device registration services, 16 years of continuous accumulation of CE, ISO, FDA, Canadian CMDCAS and other regulations experience, with more than 1000 successful counseling registration cases, the journey is magnificent, the original heart is long, in order to better serve customers, Abmed constantly improve itself. Broaden horizons, increase global business points, the existing branches and business conditions are summarized as follows:
As of this writing, Abmed has the following four international companies (companies providing regular business), as well as a number of close partners.

Abmed USA, regular business, domiciled in Washington, DC

Features: U.S. agent, medical device registration, free sale certificate CFG declaration, drug intermediates, drug packaging materials DMF declaration, cosmetic registration, food registration, laser product registration, clinical agent of some products, provide corresponding technical services for non-profit organizations, More than 200 510k numbers have been approved (including nearly 200 k numbers in the name of Shanghai Truthful).

The bank accepts US dollars.

Abmed Medical Technology Inc

Address: 800 East Wishkah Street, 1021 Aberdeen, WA 98520, United States

Tel: +303 8000162

DUNS: 118913663

Email: [email protected]; [email protected]

Account Number 202468109787

ABA Routing Number 091311229

20/08/2024

Interpretation of MDR transition regulations（2）
The manufacturer's MDD CE certificate will expire after March 20, 2023:

1) The enterprise undertakes to submit the certification application to NB institution before May 26, 2024, and to sign the MDR certification contract with NB Institution before September 26, 2024 at the latest. Pre-certified products need to be included in the MDR certification contract and can also be covered by Odai's confirmation letter (need to confirm with their existing Odai).

2) The device must continue to meet the requirements of MDD; There can be no major changes to the device; The device must not present an unacceptable risk; Manufacturers are required to establish a quality management system in accordance with the MDR by May 26, 2024; Pass the review of NB institution normally every year.

20/08/2024

Interpretation of MDR transition regulations（1）
This regulation is a bit difficult to understand, first determine if Odai is willing to issue a declaration letter for the manufacturer to facilitate the confirmation and explanation to your European customers, why the manufacturer's MDD CE certificate has expired or will expire, but the product can continue to be sold.
It can be divided into the following two situations:
The manufacturer's MDD CE certificate expired before March 20, 2023:

1) Must have signed the MDR certification contract with NB institution (just submitting the certification application is not enough). The products in the MDR certification contract can be included in the confirmation letter issued by Odai (to be confirmed with their existing Odai).

2) The device must continue to meet the requirements of MDD; There can be no major changes to the device; The device must not present an unacceptable risk; Manufacturers are required to establish a quality management system in accordance with the MDR by May 26, 2024; Pass the review of NB institution normally every year.

20/08/2024

USA UDI FAQ selection（9）

UDI requirements apply to most medical devices sold in the United States, including implantable devices, life support devices, life-sustaining devices, Class III medical devices, Class II medical devices, Class I medical devices, and devices not yet classified.
Starting September 24, 2022, medical devices exported to the United States should establish product UDI, packaging and labeling must have UDI codes, complete GUDID database upload maintenance, in order to meet FDA requirements. Packaging labels that do not meet the standards of the UDI Barcode Identification System will not be sold in the United States.

With many years of experience in UDI processing, Abmed has precise control of every link of UDI, from label creation to product sailing, helping customers and friends along the way.

20/08/2024

USA UDI FAQ selection（8）

Q14: What format of UDI does the direct marking device use?

When a device must mark UDI directly, one or both of the following techniques must be available:

(1) legible plain text and/or
(2) AIDC technology or any alternative technology that can provide device UDI on request.
However, the UDI on the device label must use both legible plain text and AIDC technology.

Q15: For instruments that require direct marking, can UDI be marked on the instrument by a sticker rather than etching or laser?

The permanence of the direct marking UDI shall be the same as the normal life expectancy of the equipment and must be able to withstand the normal use of the equipment and the specified cleaning procedures.

20/08/2024

USA UDI FAQ selection（7）

Q12:21 What are the requirements of CFR §801.45(d) for exceptions to direct labeling?

The direct marking exception applies to any device that meets any of the following four criteria:

(a) Any type of direct marking that affects the safety or effectiveness of the device;

(b) It is not possible to mark the equipment directly because it is not technically feasible;

(c) the equipment is single-use equipment and has been additional processed and manufactured for additional single-use purposes; or

(d) The device has previously been labeled in accordance with 21 CFR 801.45(a).

Q13: Do implantable devices need to mark UDI directly?

The UDI rules do not require implantable devices to directly label their UDIs. The CDRH believes that UDI labeling and packaging requirements will provide adequate labeling for implantable devices until they are implanted.

20/08/2024

USA UDI FAQ selection（6）

Q9: Where should UDI be placed?

The UDI should be affixed to the device label, the device packaging, and the device itself if the device is intended to be used multiple times and reprocessed between uses.

Q10: If there is no UDI location on the current label, can the labeler design a new label with only UDI and attach it to the package?

The UDI rules do not specify the type of label that must be marked with UDI. The appropriate method of attaching UDI to labels is at the sole discretion of the labeller. In some cases, additional labels may be appropriate. However, the UDI must appear on the device label and on each device package.

Q11: When does a device need to mark UDI directly?

Devices intended to be used more than once and intended to be reprocessed prior to each use must bear a permanent UDI on the device itself, except for exceptions in 21 CFR§801.45(d).

20/08/2024

USA UDI FAQ selection（5）
Q7: What changes require new device identifiers?

Whenever a change is made to a device that requires UDI on its label and the change results in a new version or model, a new DI must be assigned to the new version or model, "version or model" being defined as "all devices that have specifications, performance, size and composition within the limits specified by the labeller." It is the responsibility of the labeller to determine whether an upgrade or change to the device constitutes a different model or version.

Q8: Who is responsible for complying with UDI requirements, including placing UDI on device labels and packaging?

A labeller is a person responsible for attaching the label to the device, or changing or altering the label, so that the device does not need to change or modify the label when entering interstate commerce in the United States. In most cases, the labeller is the device manufacturer. device manufacturer, But a labeller may also be a specification developer, a single-use device reprocessor, or a portable packaging assembler convenience kit assembler, repackager, or relabeler.

Address

51 Bracken Road, Sandyford Business Park
Dublin
D18 CV48

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