In Vitro Diagnostics - BSI Group Arabia CAB services ... Compan Information Form In Vitro...

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Company Information Form In Vitro Diagnostics

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In Vitro Diagnostics

Let BSI help you meet the world with confidence. Our mission is to ensure patient safety while supporting timely access to global medical device

technology. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations, and certifications.

In order to start our quotation process we need certain information. For this purpose, we kindly request you to fill out the questionnaire below.

(This form can be completed and submitted using Adobe Acrobat Reader, alternatively please print clearly).

Company Information Form

Section A: Company Information.

Legal Company Name:

Address:

Country: Website:

Regulatory Correspondent:

Primary contact: Secondary contact:

Name: Name:

Position: Position:

Tel: Tel:

Fax: Fax:

Mobile: Mobile:

Email: Email:

Is your company part of a larger organization? If so, please give details of the organization:

Do you trade under any other trading names? If so, please give further details:

Authorised European Representative: (if company not resident in EU)

Legal Company Name:

Representative Title/Name/Position:

Consultants:For the products and services listed within this form, will you be using or have you previously used a Consultant to help you in your design, construction,

marketing or maintenance of the products, processes or Quality Management Systems? Yes No

(If applicable, please complete their details below)

Consultant name:

Address:

Email: Tel:



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Section B: Services requested

Please select the services you would like BSI to provide a quotation or provide information? For a description of these services please refer to the

annex at the back of this pdf or ask your sales representative for more information.

Medical Device Related Services:

Initial application Transfer from another Notified Body/Certification Body

CE certification to IVD Directive Medical device or quality system related training

Regulatory Strategy Review Safety testing (IEC 60601 and/or EMC)

ISO 13485:2016 (UKAS) Australia TGA/EU MRA Fast Track Service

(Applicable only to products manufactured in Europe)

ISO 13485:2016 (SCC) Japan PMD Act certification

Malaysia CAB product approval

Medical Device Single Audit Program (MDSAP)

Accelerated Medical Device Registration in

Taiwan (Applicable only to EU Manufacturers)

ISO 9001:2015 (UKAS)

Hong Kong CAB product approval ISO 9001:2015 (ANAB)

Saudi Arabia CAB services (Information only)

CE Marking Technical Documentation Review Services:

Please select which technical documentation review service you would like to receive a quotation for?

CE-Standard

CE-Dedicated FastTrack

CE-Onsite FastTrack



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Section C: Information required for quality system assessmentPlease complete this section if you are applying for ISO 13485/9001 and CE certification. In case of CE marking, please also complete section D (product information).

Company Organization:

If the company consists of several locations all contributing to the overall scope of any proposed application then please complete this section. Please

clearly indicate where design, manufacturing, sterilization etc take place. Use an additional sheet if necessary.

Site Details: Main Site

Name:

Address:

Functions/Activities:

Number of employees: Shift system (hours/number of shifts/number of employees per shift):

Site Details: Second Site

Name:

Address:



Site Details: Third Site

Name:

Address:





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Existing Certificate Details:

Please provide copies of any CE marking or ISO 13485 certificates held.

Main Site Second Site Third Site

Certificate Number:

Certificate Type:

Issuer of Certificate:

Current Certification Scope:

New Applications:

Suggested scope of certification of your quality system:

Client Readiness:

When will your QMS be ready for assessment?

When will your technical documentation be ready for assessment?

Main Site Second Site Third Site



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Section D: Information required for CE certification.

Please complete this section if you request a quotation for CE certification.

98/79/EC – IVD (In-Vitro Diagnostics)

Route to Conformity Which conformity assessment procedure(s) would you like to follow? Click here for our Guide to the IVDD

IVD – Annex IV (Full Quality System) IVD – Annex VI (EC Verification) IVD – Annex V (Type/Design Examination)

IVD – Annex VII (Production Quality System) IVD – Annex III.6 (Design Examination)

Product Details:

Please give details of the devices to be included in the scope of this application. Copies of any product literature should be included.

Annex II List A:

Please tick which analytes you require CE marking for and indicate how many devices you have in each category.

Number of devices Number of devices

ABO systems HIV 1 and 2

Rhesus (C, c, D. E, e) HTLV I and II

Anti-Kell Hepatitis B, C, D

If these products are already approved, for example if this is a transfer, which test laboratory conducts the verification of manufactured product?

Annex II List B:

Please tick which analytes you require CE marking for and indicate how many devices you have in each category.

Number of devices Number of devices

Anti-Duffy Cytomegalovirus

Anti-Kidd Chlamydia

Irregular Anti-Erythrocytic Antibodies HLA tissue groups (DR, A, B)

Rubella PSA

Toxoplasmosis Trisomy 21 and Software

Phenylketonuria Self Measurement of Blood Sugar

Device Name Device Description/Intended use Classification

http://medicaldevices.bsigroup.com/sites/default/files/pdfs/InVitroDiagnosticDirectiveGuide.pdf



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Self Test:

Please identify the number of self test devices and the analytes they measure:

Accessories: If any accessories are included, please give details whether sold with the product or separately:

Special Processes:

Please give details of any special processes carried out e.g. Sterilization

Please indicate brand/method of sterilization

Has/have the sterilization validation(s) been completed? Yes No

If No, please indicate the expected date of completion:

Please indicate the class of cleanroom operated, if the product is not sold sterile, but cleanrooms are used to reduce bioburden:

Novelty:

Is the device a new development to the market? Yes No

Does the device feature any novel features such as materials, technologies or intended use?

Technologies Used:

What is the technology used? (e.g. ELISA, NAT)

Sub-contractors:

Are any processes sub-contracted, e.g. design, manufacturing, sterilization, cleaning, packaging, servicing, vigilance, post market surveillance, QC Testing?

If so, please specify activity, to whom they are sub-contracted and details of any quality systems held by the sub-contractor.

Contact: Sub-contractor 1

Name:

Address:

Activity Sub-contracted:

Existing Registrations?

Please confirm whether you have provided copies of certificates: Yes No



Please return this form to BSI with a copy of your standard company information, the product brochures and any other information which you

think would be helpful in the quotation process.

Declaration:The applicant herewith declares to have lodged no application with any other Notified Body for the same device-related quality management

system.

The applicant herewith declares to have lodged no application with any other Notified Body for the same device(s).

The applicant herewith confirms that the information provided in this application is true and correct.

Name of Applicant:

Position of Applicant:

Signature: Date:

Visit us online at: bsigroup.com/medical


Name:

Address:





Name:

Address:




Additional Information:Please use this area to provide any additional information including audit language requirements which you think would be helpful in progressing

the quotation process:

http://bsigroup.com/medical



Annex: Description of services.

Description of BSI Medical Device Related Services:

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CE marking

CE marking is the medical device manufacturer’s claim that a product

meets the essential requirements of all relevant European Directives

and is a legal requirement to place a device on the market in the

European Union. The three medical devices directives are:

• Medical Devices Directive (MDD)

• Active Implantable Medical Devices Directive (AIMDD)

• In Vitro Diagnostics Directive (IVDD)

The EU Medical Device Directives are Changing, BSI can provide further

information on the changes via our transition pages:

bsigroup.com/IVDR-revision and bsigroup.com/MDR-revision.

Regulatory Strategy Review

Achieving agreement between a manufacturer and their Notified Body

is essential in determining regulatory strategy and represents a major

milestone in helping to demonstrate the product launch is on target.

BSI provides a written gap analysis report against the relevant

requirements, supplying feedback on your Strategy Plan based on the

latest European Regulations, Standards and Guidance. Based on the

information supplied, this report can help identify deficiencies within

your technical documentation and compliance with the regulatory

requirements.

In addition, knowledge upfront provides a cost-effective and timely

opportunity to amend your strategy if needed.

The Regulatory Strategy Review is made up of four subsets, that you

can choose for review. You can request more than one service, all of

the services are available only as part of the BSI CE marking process;

only Manufacturers who have committed to CE marking their product

with BSI can make use of the service.

Australia – Conformity Assessment Body (CAB)

Importers of medical devices in Australia need to meet the

requirements of the Therapeutic Goods Administration of Australia.

BSI is designated as a Conformity Assessment Body under the Mutual

Recognition Agreement (MRA) between EU and Australia.

Japan – PMD Act and PMDA approval Pharmaceutical and Medical

Device Act (PMD Act) regulation.

The distribution of medical devices in Japan is regulated in accordance

with the Pharmaceutical and Medical Device Act (PMD Act) regulation

by the Ministry of Health, Labour and Welfare (MHLW). The former

regulation, Japanese Pharmaceutical Affairs Law (JPAL) was replaced

by PMD Act on November, 25, 2014. The revision includes third party

certification systems for Class III medical devices and expansion of the

responsibility of quality management system to legal manufactures.

Because of the complexities of PMD Act and the involvement of

Japanese and international governmental bodies, we can help you

understand device classifications, prepare for the review process, and

help you meet standards.

Taiwan, Technical Cooperation Programme (TCP)

The TCP allows exchange of Medical Device GMP and ISO 13485 Audit

Reports between Republic of China, Department of Health Designated

Medical Device GMP Auditing Organizations and EU AIMD/MDD/IVDD

Notified Body Partners.

Hong Kong CAB

BSI was the first Hong Kong CAB under the Medical Device

Administrative Control System. Using BSI as your HK CAB means BSI

CE marking clients need only to submit a minimal amount of technical

documentation and companies can get the CE marking and HK

Registration with one assessment.

Malaysia CAB

As of the 1st of July 2013, the Malaysian Medical Devices Act 2012 (Act

737) will be fully enforced in the country, BSI has been approved as a

CAB. Working with a conformity assessment body is essential for any

medical device organization to register their medical device products,

be certified to a medical device quality management system or to

attain certification for their Good Distribution Practices for Medical

Devices (GDPMD).

Brazil

BSI Brazil has extended their scope of INMETRO accreditation to

include product certification to 60601 (safety of electro-medical,

active, devices). INMETRO 60601 product certification is mandatory

for electro-medical devices intended to be placed into Brazil before

the manufacturer can receive ANVISA regulatory market clearance.

As a INMETRO product certification body BSI Brazil can now receive

applications from manufacturers outside Brazil.

Transfer from another Notified Body

If you decide to transfer your certification to BSI, we can offer a

seamless exercise with comprehensive support and the absolute

minimum level of disruption. With expertise encompassing the full

range of industry sectors and management system standards.

http://bsigroup.com/IVDR-revision

http://bsigroup.com/MDR-revision



Quality Management

ISO 13485 Quality Management

ISO 13485 is an international standard recognized for medical device

QMS registration. It helps manufacturers consistently manufacture

devices that are safe and fit for their intended purpose and meet

regulatory requirements for manufacturing control. BSI is an

accredited third party that conducts on-site assessments and makes

recommendations.

Medical Device Single Audit Program (MDSAP)

The Medical Device Single Audit Program (MDSAP) is an international

initiative where Auditing Organizations (AO) can conduct a single audit

of a medical device manufacturer that would be accepted by multiple

regulators to address QMS/GMP requirements.

Five of the RAs (Australian TGA, Brazilian ANVISA, Health Canada, US

FDA and Japanese MHLW) have completed a three year MDSAP pilot

in 2016, the programme is now live. Health Canada has announced

that as of 1 January 2019, they will terminate their current CMDCAS

program and only accept MDSAP certificates.

Pre-Assessment Service

An opportunity for a company to have an informal preliminary

assessment that will not affect the outcome of the registration.

This service will identify major flaws or gaps in the systems that the

manufacturer can then correct.

CE Marking Technical Documentation Review Services:

CE-Standard

The CE-Standard review service allows you to work closely with your

assigned BSI Product Expert on your product certification. These

reviews are conducted remotely, with communication between you

and your BSI Product Expert via phone and email, as required.

CE-Dedicated FastTrack

The CE-Dedicated FastTrack review service allows you to schedule your

technical documentation review with a dedicated BSI Product Expert.

The review is conducted remotely via teleconferencing, allowing you to

engage with your dedicated BSI Product Expert and provide immediate

responses to their questions. This allows predictability in planning for

the review, and can improve the efficiency of the review process.

CE-Onsite FastTrack

The CE-Onsite FastTrack review service is conducted at your premises;

a BSI Product Expert visits the facility for a period of time. CE-

Onsite FastTrack reviews allow for dynamic communications and

opportunities for immediate responses to questions raised by the

reviewer. Planning a CE-Onsite FastTrack review in advance provides

you with more predictability and the reassurance of knowing when

your BSI Product Expert will be at your premises.

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For more information on our CE-Excellence services visit:

Call: +44 345 080 9000 or visit: bsigroup.com/ce-excellence

http://bsigroup.com/ce-excellence



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Additional Resources:

Medical Device eUpdate Service

Keep updated on what’s happening in the industry and changes in

regulatory and quality requirements. You can take advantage of this

free service by signing up at our website.

Informative webinars

Hear regular updates from our experts on key topics; listen live or

listen back.

Comprehensive white papers

Our technical specialists collaborate with external experts to bring

you the latest views and understanding on complex regulatory issues.

Download your complimentary copies now.

Guidance documents

Our online guidance documents provide assistance in understanding

the regulatory requirements for medical devices.

Standards

BSI British Standards delivers leading-edge best practice solutions

through the development and publication of more than 34,000

standards and related products.: bsigroup.com/standards

Training

BSI’s range of course offerings is among the most comprehensive

available and addresses the needs of quality and regulatory

professionals. BSI offers public, onsite, e-learning and webinar training

courses. You can view courses at: bsigroup.com/medical-training

Join our Linkedin Group

https://www.linkedin.com/groups?gid=5100466

Visit us online at: bsigroup.com/medical

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T: +1 800 862 4977 / 703 437 9000 T: +44 (0)345 080 9000 T: +852 3149 3320

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registered and unregistered trademarks owned by The British Standards Institution in

United Kingdom and certain other countries throughout the world.

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In Vitro Diagnostics - BSI Group Arabia CAB services ... Compan Information Form In Vitro...

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