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© Saudi Food and Drug Authority – Official Document

MEDICAL DEVICES SECTOR

Implementing Rules Document “MDS/CAD/IR2“

Version 1.0

Validation of Documents Provided to the SFDA by

Manufacturers Applying for Market Authorisation

Developed Date

Effective Date

I © Saudi Food and Drug Authority – Official Document I

Our mission is to ensure the safety of food; the safety, quality and efficacy of drugs; and the safety and effectiveness of medical devices, by developing and enforcing an appropriate regulatory system. SFDA Our mission is to ensure safety, efficacy, and quality of medical devices and their performance according to their intended purpose, and to ensure the safety of related electronic products. Medical Devices Sector

II © Saudi Food and Drug Authority – Official Document II

Further Information Medical Devices Sector – Saudi Food and Drug Authority SFDA – 3292 North Ring road Al Nafel Area Unit (1) Riyadh 13312 – 6288 KSA Tel +966 1 2759222 Fax: +966 1 2757245 www.sfda.gov.sa [email protected]

Implementing rules are administrative instruments used as a part of Medical device Regulation and having a force of law. It should be relied on, to ensure medical devices placed on the market of the KSA will achieve an appropriate level of safety and performance with regard to the manufacture, supply and use of medical devices, to address every aspect of relevant legislation. Please refer to the SFDA – MDS regulation 2009 for legislative requirement.

III © Saudi Food and Drug Authority – Official Document III

Document Change Log

Document Number Replaces

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Date Date

Change Location ( Section, Paragraph) Nature of and/ or Reason for Change

IV © Saudi Food and Drug Authority – Official Document IV

Table of Contents

1. Introduction .................................................................................................................................... 1 2. Definitions............................. .......................................................................................................... 1 3. General ............................................................................................................................................ 2 4. Documentation to be provided to, or kept available for inspection by, the SFDA ......................... 2 5. Language requirements for the documentation to be provided to, or kept available for inspection by, the SFDA........................................................................................................................................ 4 6. The evaluation of the application and validation of documents ...................................................... 4 7. Marketing authorization................................................................................................................. 5 ANEX : The applications for the Validation Documents .................................................................... 6 General Information ............................................................................................................................. 7 Information Specific to a Medical Device that complies with the Regulations that apply within Australia ............................................................................................................................................. 10 Information Specific to a Medical Device that complies with the Regulations that apply within Canada ................................................................................................................................................ 12 Information Specific to a Medical Device that complies with the Regulations that apply within EU ...................................................................................................................................................... 14 Information Specific to a Medical Device that complies with the Regulations that apply within Japan................................................................................................................................................... 16 Information Specific to a Medical Device that complies with the Regulations that apply within U.S.A .................................................................................................................................................. 18

1 © Saudi Food and Drug Authority – Official Document 1

1. Introduction

The Saudi Food and Drug Authority (SFDA) is developing Medical Device Regulation for the Kingdom of Saudi Arabia (KSA). Until such time as these regulations come into force the KSA has adopted an Interim Marketing Authorisation Scheme1 (Interim Scheme), which will be complemented by Implementing Rules. The Interim Scheme and its Implementing Rules will ensure medical devices placed on the market of the KSA will achieve an appropriate level of safety and performance with regard to the manufacture, supply and use of medical devices.

2. Definitions

a. Accessory: a products intended specifically by a manufacturer to be used together with a medical device to enable that medical device to achieve its intended purpose.

b. Authorised representative: any natural or legal person established within the KSA who has received a written mandate from the manufacturer to act on his behalf for specified tasks as defined in the Interim Marketing Authorisation Scheme.

c. Distributor: any natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device to the end user.

d. Fully refurbished medical device: a used device that has been returned to a state which would allow it to be subject to the same conformity assessment procedures as applied to a new device.

e. Importer: any natural or legal person in the supply chain who first makes a medical device, manufactured in another jurisdiction, available in the KSA.

f. Labelling: written, printed or graphic matter

• affixed to a medical device or any of its containers or wrappers, and/or

• accompanying a medical device,

related to identification, technical description, safety and use of the medical device, but excluding shipping documents.

g. Lay person: individual that does not have formal training in a specific field or discipline.

h. Manufacturer: any natural or legal person who designs and/or manufactures a medical device with the intention of making the finished medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by a third party(ies).

i. Medical device: any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

i) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

1 [Insert reference to the appropriate legal instrument]


• diagnosis, prevention, monitoring, treatment or alleviation of disease, • diagnosis, monitoring, treatment, alleviation of or compensation for an injury, • investigation, replacement, modification, or support of the anatomy or of a

physiological process, • supporting or sustaining life, • control of conception, • disinfection of medical devices, • providing information for medical or diagnostic purposes by means of in vitro

examination of specimens derived from the human body;

and

ii) which does not achieve its primary intended action in or on the human body by pharmaco-

logical, immunological or metabolic means, but which may be assisted in its intended

function by such means.

j. Person: a term that includes legal entities such as a corporation, partnership or an association.

k. Supply(ing) to the market: the making available, in return for payment or free of charge, of a device, other than a device intended for clinical or performance evaluation, with a view to distribution and/or use on the market.

3. General

The Interim Scheme requires manufacturers wishing to supply a medical device in the KSA, to provide the SFDA with documentation that demonstrates compliance of the device with the provisions that apply to it, i.e. proof that the manufacturer is authorized to place the device on the market of one of the GHTF Founding Member jurisdictions and that it complies with the specific national requirements of the Interim Scheme.

This Implementing Rule specifies and/or completes these requirements and describes the validation process.

4. Documentation to be provided to, or kept available for inspection by, the SFDA

The manufacturer shall either directly, or through his authorized representative, complete an application form as shown in Annexes 1 to 5 ,accessible through the SFDA’s web site at (Drafting Note: insert website address when known) and provide the SFDA with documentary evidence, as follows:

a. Contact details for the manufacturer and authorized representative, if any.


b. An indication of the manufacturer’s registration number2 under the SFDA’s Medical Device National Registry (MNDR).

c. The documents that show the medical device complies with the Medical Device Regulations of at least one of the GHTF (Global Harmonization Task Force) Founding Member countries, namely Australia, Canada, Japan, the USA or the EU/EFTA countries3. Such documents shall include evidence that the medical device has been judged as safe and performing as the manufacturer intended, as well as evidence, where such is required, that the manufacturer’s quality management system is in place and subject to independent audit. Where the manufacturer has decided to implement a quality system that is not mandatory under the relevant legislation, evidence of its proper application shall be provided.

d. A declaration to attest that the medical device complies with the provisions of the medical device regulations of a GHTF Founding Member jurisdiction.

e. A copy, in electronic form, of the labelling associated with the medical device that will be placed on the market of the KSA, and show that the text of the different elements of the labelling and their content take appropriate account of the intended use of the devices and the qualifications of the users in the KSA.

f. Information on any measures taken to accommodate the specific environmental and/or conditions of use (e.g. temperature, power supply variability, electro magnetic compatibility etc.) encountered in the KSA.

g. Information of the procedures to ensure its medical devices that are put into service within the KSA are correctly stored, transported, installed, maintained and disposed of by qualified persons, and users can be trained in their proper use and maintenance.

h. Where the medical device has been supplied legitimately to the market of the GHTF Founder Member jurisdiction without being subject to third-party assessment, the SFDA may, when duly justified, require the manufacturer to provide a summary of the documents that demonstrate compliance with the relevant regulations.

i. A declaration to attest that the medical device complies with the provisions of the Interim Scheme and the relevant Implementing Rules.

j. A copy of the advertising and marketing materials, if any.

k. An undertaking to report to the SFDA’s National Centre for Medical Device Reporting (NCMDR), any adverse event of which it becomes aware, that involves the medical device, as specified in the specific Implementing Rule.

l. A copy of the written mandate4 that defines the designated responsibilities of the manufacturer’s authorised representative, if applicable.

2 The MNDR registration number shall be notified to the SFDA as soon as it becomes available since the marketing authorization is conditional upon it being provided. 3 See also the document: Guidance for the documents to be provided and held by a manufacturer making an application for Saudi Marketing Authorization for a medical device that complies with European Regulations 4 If the authorized representative has been appointed at the time of the application, if not a copy of the written mandate shall be provided to the SFDA before it will issue the marketing authorization.


5. Language requirements for the documentation to be provided to, or kept available for inspection by, the SFDA

a. Documents to be provided to the SFDA that relate to the original market authorization in the GHTF Founder Member jurisdiction shall be in English, unless the SFDA has given prior agreement that another language is acceptable. However, where the language used is other than English, a summary and/or translation of the relevant parts of the document shall be provided in English.

b. The manufacturer shall indicate to the SFDA the location of the technical documents that support its Declaration of Conformity that the medical device complies with the provisions of the medical device regulations of a GHTF Founder Member jurisdiction. When duly justified, the SFDA may request the applicant to provide parts of this technical documentation. Where the language used in such documentation is other than English, the applicant shall indicate this fact to the SFDA and may be requested to provide an English translation of the relevant parts of such documents.

c. Labelling in the English language is acceptable where the user(s) of the medical device is likely to be professionally qualified. If the device is for use by a lay person, labelling shall be in Arabic and English.

d. The following documents shall be in English:

e. measures related to the application of the specific national measures;

f. the declarations attesting that the medical devices comply with the regulation of the GHTF founding member and with the relevant specific national provisions;

g. the undertaking to report adverse events; and

h. the mandate nominating the authorized representative, if any.

i. Instructions for the storage, transportation, installation and maintenance of the medical device shall be in both English and Arabic.

j. Advertising and marketing information shall be in both English and Arabic.

6. The evaluation of the application and validation of documents

The application process will verify if all the appropriate information is provided and require additional documentation, where necessary.

The SFDA shall allocate each application with its associated documents to a CAB (Conformity Assessment Body), duly appointed5 to assist the SFDA, and ask it to verify that the medical device complies with the provisions specified in this Interim Scheme. It is not intended that the CAB repeats the work undertaken by the Regulatory Authority or certification bodies of the GHTF

5 The criteria for appointing a CAB are specified in the Interim Scheme and in the Implementing Rule entitled “Designation and Oversight of Conformity Assessment Bodies.”


Founding Member jurisdiction. However, it will inspect the certificate/s provided and scrutinise certain of the other documents provided to it and confirm to its own satisfaction that the documentation accompanying the application is sufficient and applies to the subject medical device.

The CAB determines the adequacy of the documentary evidence in support of the applicant’s attestation of conformity with the:

• specified regulations of a GHTF Founder Member jurisdiction, and

• national provisions of the Interim Scheme.

Where the evidence offered is inadequate, the CAB will ask the SFDA to request the applicant for additional technical documentation but, where it does so, must justify such a request. It may also verify directly with the organisations that have issued the certificates provided by the applicant that they have not expired and/or the conditions of their validity.

The CAB may request the SFDA to interrogate the MDPRC database for any reported incidents that involve the medical device that is the subject of the market authorization application.

When the CAB has reached a conclusion as to whether or not the manufacturer has met the requirements of the Interim Scheme it shall inform the SFDA of its findings. The CAB shall recommend to the SFDA the period for which the authorization shall run taking into account the validity of the original authorization issued by the GHTF founding country.

7. Marketing authorization

When satisfied that the manufacturer or his authorized representative has provided all the information required, the SFDA shall issue a market authorization in writing to the manufacturer that permits the relevant medical devices to be placed on the market of the KSA. The marketing authorization shall incorporate the dates of both its issue and expiry, taking into account, among other factors, the conditions of validity of the original authorizations, if any

The authorization issued by the SFDA that permits the medical device to be marketed within the KSA shall be in English.

Note: For the purpose of the Interim Scheme, only those contact lenses and laser surgical equipment for cosmetic rather than for medical applications shall be authorized in the KSA , which are authorized in one of the GHTF founding member countries under their medical device regulation .


ANNEXES

The applications for the Validation Documents

General Information


Name of applicant organisation: Role of applicant organisation: Manufacturer / Authorized Representative

Contact details of manufacturer (always required)

Address

Telephone number Facsimile number

E-mail address Web site address Establishment registration number (manufacturers established in the KSA only)

Contact details of authorized representative (required if the manufacturer is established outside the KSA)

Address

Telephone number Facsimile number

E-mail address Web site address Establishment registration number

Name and contact details of person responsible for the application Name of person Position within organisation

Address (if different to above)

Telephone number Facsimile number E-mail address

Details of medical device Trade/Brand Name (optional ): Model Number (optional ): Device type / description: Manufacturer’s device identifier number (e.g. catalogue number)

Medical device listing number assigned to the device by the SFDA Number: :

Nomenclature code number (if any): GMDN: UMDNS: Other:

Regulatory status of the device in GHTF Founder Member Jurisdictions

Jurisdiction(s) where this medical device has been placed legally on the market.

Australia: Yes / No Canada: Yes / No EU: Yes / No Japan: Yes / No USA: Yes / No

Other documents required by the specific national provisions of the KSA Has the label(s) affixed to the device or its wrappers when it is supplied to the KSA been provided? Yes / No


Has the ‘instructions for use’ document intended for KSA users of the medical device been provided? Yes / No Has information on any measures taken to accommodate the specific environmental and/or conditions of use encountered in the KSA been provided?

Yes / No

Has a copy of the manufacturer’s instructions to ensure that its medical devices placed on the market of the KSA are correctly stored, transported, installed, maintained and disposed of; and that users can be trained in their proper use and maintenance; been provided?

Yes / No

Have copies of the manufacturer’s advertising and marketing material for use in the SFDA been provided? Yes / No / not relevant Has the manufacturer provided an undertaking to report to the SFDA’s National Centre of Medical Devices Reporting (NCMDR), any Field Safety Corrective Action of which it becomes aware, that may affect medical devices supplied to the KSA?

Yes / No

Where the applicant is the manufacturer’s authorized representative, has a copy of the written mandate that defines the responsibilities designated to it by manufacturer been provided?

Yes / No /

not applicable


* The Application Will Appear According to the Selected Jurisdiction

Please select the GHTF Founding Member jurisdiction that is the basis of the application for marketing authorisation within the KSA

Australia

Canada

EU

Japan

USA


Information Specific to a Medical Device that complies with the Regulations that apply within Australia

Details of medical device Classification of medical device (delete as applicable)

AIMD or MD Class III / IIb / IIa / I / custom-made device / procedure pack

For Class I medical devices only indicate Sterile or non- sterile / with measuring function or no measuring function

Classification of IVD medical device (delete as applicable)

Annex II List A / Annex II List B / Self-test / General IVD (other)

is the IVD ‘listable’ ‘registrable’ or ‘exempt’ from the Australian Register of Therapeutic Goods?

Listable / Registrable / Exempt

Documentary evidence of regulatory status Has the TGA listed the device as conforming to its regulations on its Register of Therapeutic goods?

Yes / No

Product verification and validation evidence that the medical device is safe and performs as intended by the manufacturer and in conformity

with the relevant Australian regulationWhich conformity assessment process has been applied? (record relevant Article(s) and Annex(s) of the Australian regulation that applies to the device)

Article: Annex:

Have the appropriate essential documents, decisions or reports, as required by the regulations for the class of device that is the subject of the application been provided6?

Yes / No / none required for the class of device

Are these documents valid with respect to issue and expiration dates?

Yes / No

Has the design changed in a manner that could affect safety and/or performance since the relevant certificate was issued by the TGA?

Yes / No

If the device or the IVD is Class I, indicate the location of the technical information that demonstrates that the device is safe and performs as intended by the manufacturer.

If the device is Class I, or a General IVD device, has the TGA listed it on its Register of Therapeutic goods?

Yes / No

Is the design and/or construction of the medical device sub-contracted by the manufacturer to another party?

Yes / No

If the medical device is supplied sterile, has a document been provided to show that a Notified Body has verified the procedures and processes relevant to sterility?

Yes / No

6 See separate guidance specifying the documents to be provided and/or held by a manufacturer making an application for Saudi Marketing Authorization for a medical device that complies with European Regulations.


Manufacturer’s quality system status Has the manufacturer of the medical device an established quality management system (QMS)?

Yes / No

Does this QMS comply with the quality requirements of the conformity assessment procedure specified in the previous section?

Yes / No

Indicate the type of QMS used. (delete as applicable)

ISO 13485 / manufacturer’s own scheme

Indicate the procedures and processes covered by the manufacturer’s QMS.

design and development

Yes / No

manufacturing Yes / No final product testing

Yes / No

Is the QMS regularly audited by the TGA? Yes / No if YES, provide a copy of the most recent Valid QMS certificate issued by the TGA.

Date of expiry: / /

If the QMS is regularly audited by an independent organisation other than a Notified Body, provide the name of that organisation

Other documents required by the specific national provisions of the KSA Has the manufacturer provided a written Declaration of Conformity, to attest that the medical device complies with the provisions of the medical device regulations of Australia and with the national provisions of this Interim Regulation been provided?

Yes / No

Indicate the location of other documents held by the manufacturer to support this Declaration of Conformity.

Has all the documentary evidence related to the specific national provisions been provided and/or made available in the appropriate language7?

Yes / No

Signature of the person responsible for the application

Date of the application

7 See separate guidance specifying the language requirements of the documents provided related to the specific national provisions of the KSA.


Information Specific to a Medical Device that complies with the Regulations that apply within Canada


Class I / II / III / IV

Classification of IVD medical device (delete as applicable) Class I / II / III / IV

Documentary evidence of regulatory status Has Health Canada licensed the device? Yes / No if YES, indicate the License Number Product verification and validation evidence that the medical device is safe and performs as intended by the manufacturer and in conformity with the relevant

Canadian regulationsHave the appropriate essential documents, decisions or reports, as required by the regulations for the class of device that is the subject of the application, been provided?


Are these documents, if any, valid with respect to issue and expiration dates? Yes / No

Has the design changed in a manner that could affect safety and effectiveness since the device being licensed by Health Canada?

Yes / No

if YES, has Health Canada issued a new license? Yes / No

Is the production of the medical device sub-contracted by the manufacturer to another party?

Yes / No

If the device or the IVD is Class I, does it comply with the safety and effectiveness packaging , labelling and post-market requirements of the Canadian Medical Devices Regulation

Yes / No

If the medical device is supplied sterile, has a document been provided to show that Health Canada has verified the procedures and processes relevant to sterility?

Yes / No

Manufacturer’s quality system status Indicate the procedures that are encompassed within the manufacturer’s QMS.


Yes / No

manufacturing Yes / No Is the QMS regularly audited by registrars recognised by Health Canada?

Yes / No

if YES, provide a copy of the most recent Valid QMS certificate. Interval of Audit: / /

Name of the registrar responsible for the QMS audit, if any Other documents required by the specific national provisions of the KSA

Has the manufacturer provided a Declaration of Conformity, written in English, to attest that the medical device complies

Yes / No


with the provisions of the medical device regulations of Canada and with the national provisions of this Interim Regulation? Indicate the location of other documents held by the manufacturer to support this Declaration of Conformity.


Yes / No





Information Specific to a Medical Device that complies with the Regulations that apply within EU

Details of medical device Classification of medical device (delete as applicable) AIMD or MD Class III / IIb / IIa / I /

custom-made device / procedure pack for Class I devices only indicate Sterile or non- sterile / with measuring

function or no measuring function Classification of IVD medical device (delete as applicable)

Annex II List A / Annex II List B / Self-test / General IVD (other)

Product verification and validation evidence that the medical device is safe and performs as intended by the manufacturer and in conformity with the relevant

EU regulatory requirements

Which conformity assessment procedure has been applied?

Directive:

Article:

Annex(es): Have the appropriate essential documents, decisions or reports, as required by the regulations for the class of device that is the subject of the application9, been provided?


Are these documents valid with respect to issue and expiration dates? Yes / No

Name or reference number of the NB responsible for issuing the certificates, decisions or reports provided above, if any.

Has the design changed in a manner that could affect safety and/or performance since the relevant certificate was issued by the NB?

Yes / No

If the device is Class I, or a General IVD device, indicate the location of the technical information that demonstrates that the device is safe and performs as intended by the manufacturer.

If the device is Class I, or a General IVD device, indicate the name of the Regulatory Authority with whom the manufacturer has been registered.

Is the design and/or construction of the medical device sub-contracted by the manufacturer to another party? Yes / No

If the medical device is supplied sterile, has a document been provided to show that a Notified Body has verified the procedures and processes relevant to sterility?

Yes / No

Manufacturer’s quality system status Has the manufacturer of the medical device an established quality management system (QMS)? Yes / No

Does this QMS comply with the quality requirements of the conformity assessment procedure Annex specified in the previous section?

Yes / No

9 See separate guidance specifying the documents to be provided and/or held by a manufacturer making an application for Saudi Marketing Authorization for a medical device that complies with European Regulations.


Indicate the type of QMS used (delete as applicable). ISO 13485 / manufacturer’s own scheme

Indicate the procedures and processes covered by the manufacturer’s QMS.

design and development Yes / No manufacturing Yes / No final product testing Yes / No

Is the QMS regularly audited by a Notified Body? Yes / No if YES, indicate the reference number or name of that NB. if YES, provide a copy of the most recent valid QMS certificate issued by the Notified Body. Date of expiry:

/ / If the QMS is regularly audited by an independent organisation other than a Notified Body, provide the name of that organisation

Other documents required by the specific national provisions of the KSA Has the manufacturer provided a written Declaration of Conformity, to attest that the medical device complies with the provisions of the relevant EU medical device directive and with the national provisions of this Interim Regulation?

Yes / No



Yes / No





Information Specific to a Medical Device that complies with the Regulations that apply within Japan


Class I / II / III / IV For Class II:

Designated Controlled Medical Device or Not Classification of IVD reagent (delete as applicable) Class I / II / III

Documentary evidence of regulatory status

Has the MHLW or Registered CAB issued a marketing authorization/ certification to the Marketing Approval Holder?

Yes / No Approval

(SHONIN) No.

Certified (NINSHO)

No.

Notification No. Product verification and validation evidence that the medical device is safe and performs as intended by the manufacturer and in conformity with the relevant

Japanese regulationsWhich conformity assessment process has been applied?

Through MHLW + PMDA / CAB

Has a certificate of conformity confirming the design has been assessed by MHLW or an authorized CAB been provided?

Yes / No / not required

Date of issue: / /

Name of the CAB responsible for assessing the design, if any.

Has the design changed in a manner that could affect safety and/or performance since the marketing authorization / certification was issued?

Yes / No

if YES, has the revised marketing authorization/ certification been issued?

Yes / No

Have the appropriate essential documents, decisions or reports, as required by the regulations for the class of device that is the subject of the application, been provided?

Yes / No

Is the construction of the medical device sub-contracted by the manufacturer to another party?

Yes / No

If the medical device is supplied sterile, has a document been provided to show that the PMDA, the prefectural government , or a Registered Certified Body has verified the procedures and processes relevant to sterility?

Yes / No


Yes / No

Indicate the procedures that are encompassed with the Manufacturer’s

A. Medical Device B. Packaging / kitting / labelling


QMS

C. Biological – Origin Medical Device D. IVD Reagent

Is the QMS regularly audited by PMDA, the prefectural government , or a Registered Certified Body?

if YES, has a copy(ies) of the most recent notification of conformity been provided?

Name of the registered certified body responsible for the QMS audit, if any?

Other documents accompanying this application Has the manufacturer provided a Declaration of Conformity, written in English, to attest that the medical device complies with the provisions of the medical device regulations of Japan and with the national provisions of this Interim Regulation been provided?

Yes / No



Yes / No





Information Specific to a Medical Device that complies with the Regulations that apply within U.S.A


Class III / II / I / other (provide details)

Classification of IVD medical device (delete as applicable)

Class III / II / I

Product verification and validation evidence that the medical device is safe and performs as intended by the manufacturer and in conformity with the relevant

FDA regulations Indicate pre-market submission status of the medical device. (delete as applicable)

PMA / 510(k) / Class I exempt

Has the 510 (k) clearance letter, or PMA approval, authorizing the marketing of the device been provided?

Yes / No / not required

Date of issue: / /

Has the FDA subsequently issued amendments to the original clearance letter, or PMA approval?

Yes / No / not relevant

Has the design changed in a manner that could affect safety and/or performance since the 510 (k) clearance letter, or PMA approval, authorizing the marketing of the device was issued?

Yes / No

Name of the Competent Person responsible for reviewing the 510(k), if any.

Have the appropriate essential documents, decisions or reports been provided?

Yes / No

Are these documents valid with respect to issue and expiration dates?

Yes / No

If the device is Class I exempt, indicate the location of the technical information that demonstrates that the device is safe and performs as intended by the manufacturer.

Has the manufacturer complied with the FDA’s registration and listing requirements?

Yes / No

Is the construction of the medical device sub-contracted by the manufacturer to another party?

Yes / No

If the medical device is supplied sterile, has a document been provided to show that the FDA Body has verified the procedures and processes relevant to sterility?

Yes / No


Yes / No

Indicate the type of QMS used. (delete as applicable)

FDA Quality System Regulation / manufacturer’s own scheme acceptable to FDA


Indicate the procedures that are encompassed within the manufacturer’s QMS.


Yes / No

manufacturing Yes / No Has the QMS audited by the FDA? Yes / No

if YES, provide the date of the most recent audit. / / Has the QMS audited by an Accredited Person? Yes / No name of the Accredited Person responsible for the QMS audit, if any

if YES, provide the date of the most recent audit. / / Other documents required by the specific national provisions of the KSA

Has the manufacturer provided a Declaration of Conformity, written in English, to attest that the medical device complies with the provisions of the medical device regulations of the USA and with the national provisions of this Interim Regulation?

Yes / No



Yes / No


