E-Mail: medical_devices@nhra.bh Website: www.nhra.bh Tel.: 17113299 /P.O. Box: 11464

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Combined Medical Device Importation Guideline

(Manual Approval)

National Health Regulatory Authority (NHRA)

Kingdom Of Bahrain

Oct 2018

Version 1.0

E-Mail: medical_devices@nhra.bh Website: www.nhra.bh Tel.: 17113299 /P.O. Box: 11464

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Contents

1. Definition ............................................................................................................... 3

2. Introduction .......................................................................................................... 3

3. General Rules ....................................................................................................... 4

4. Classification ......................................................................................................... 5

5. Process ................................................................................................................... 6

6. Requirements ........................................................................................................ 6

7. Glossary ................................................................................................................. 9

8. Annex ...................................................................................................................11

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1. Definition

Combined medical device: Term used in the kingdom of Bahrain to

differentiate between Medical devices with Pharma HS code that requires

manual approval and Active Medical devices HS code. Most of these device are

mixed with pharmaceutical or chemical materials and does not achieve their

action by pharmacological, immunological or metabolic means, used for

prevention of illness. It also covers IVD with pharmaceutical or biological

materials.

IVD (In-Vitro Diagnostic): any Medical Device which is a reagent, reagent

product, calibrator, control material, kit, instrument apparatus, equipment, or

system, whether used alone or in combination, intended by the manufacturer to

be used in vitro for the examination of specimens, including blood and tissue

donations, derived from the human body, solely or principally for the purpose

of providing information:

• concerning a physiological or pathological state, or

• concerning a congenital abnormality, or

• to determine the safety and compatibility with potential recipients, or

• To monitor therapeutic measures.

2. Introduction

This guideline is intended to guide all importers through the process of getting combined

medical device (CMD) importation approval. In order to help planning the importation of

CMD all importers should follow this guideline before placing any order or even

marketing the device in Bahrain market.

The requirements and the process required by NHRA to grant a preapproval for CMD is

highlighted in this guideline whereas, Compliance with international standards of quality

and safety of the devices is one of the main elements to importation pre-approval.

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3. General Rules

1. Pre-approval is required before importation and NHRA regulates the

importation of Medical devices

2. NHRA Regulates the importation of medical devices Class II and III only

3. All Importers should market Medical devices to Healthcare Facilities licensed

by NHRA

4. Importation of Combined medical devices must be done through authorized

representative from the legal manufacturer

5. If the product in the submitted request is registered as a medical device in Saudi

food and drug and has a valid SFDA (Medical Device Marketing authorization)

then it can be replaced for QAC & QMC and the request will be approved directly.

6. One of the following 15 reference countries should classify the product as a medical

device (Saudi Arabia, America, Australia, Canada, Japan, New Zealand,

Switzerland, United Kingdom, France, Ireland, Netherlands, Denmark, and

Belgium).

7. If the product classification is class I, Non sterile and made in one of the

European Countries then a Declaration of conformity document from the

manufacturer should be submitted with the request and can be replaced for QAC

& QMC.

8. Shipments imported for researches and will not be used on patients, will be

approved with only a Declaration of conformity with international quality and

safety standards issued by the manufacturer; if the LPO from the university is

provided

9. NHRA registered CMD importation pre-approval is done by providing only the

invoice with the product registration certificate.

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10. In case of importing Cold chain products, i.e. (2-8 ℃), the temperature data logger

must be provided to NHRA to ensure good storage conditions; from the port of

shipping “the manufacturer”, to Bahrain ports. Conditional Preapproval will be

granted before the shipment arrives, given that the importer does not distribute the

devices until NHRA approves the data logger after the shipment arrives.

11. There are two types of combined medical devices approval:

1. Approval to sell combined medical devices to only healthcare professional

(ex: Filler).

2. Approval to sell combined medical devices with prescription (ex:

injectable hyaluronic acid for joints).

4. Classification

The criteria of Medical devices classification are as below, where product must be in

compliance with all criteria in order to classify the product as medical device:

1-Product is classified in country of origin as medical devices.

2- One of the reference countries classify the product as a Medical device

3-The product is FDA approved or CE marked.

4-Product medical claim falls under the definition of medical device.

5-Product principle intended action is physical or mechanical.

• All Combined Medical devices registered before April 2016 will be reviewed once are

tended to be renewed to match with the new classification requirement

• All registered combined medical devices that were classified by the product

classification team members, can be renewed without reclassification.

For further guidance on classification for the devices that does not fulfill the above

mentioned criteria, please refer to the classification guideline of medical devices on the

NHRA website.

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5. Process

Submission of combined medical device requests is done manually, applicant should

send an email to “Medical_Devices@nhra.bh” to fix an appointment for submitting the

required documents.

Once the appointment is set the documents will be reviewed and assessed at the same

time.

In case there are missing documents the documents will be given back to the applicant

in order to fulfill the requirement.

If the documents are fulfill then the applicant will be contacted within maximum one

week to collect the approval which in this case will be granted manually (NHRA

stamp and signature) on the submitted invoice with the submitted documents.

6. Requirements

All Importers should submit the following required documents manually to get the

importation permit for combined medical devices:

Product should be classified in country of origin as medical devices. this

Document should be from the Regulatory Authority in the Country of origin to the

legal manufacturer, excluding Lab reagents

One of the 15 reference countries classifies the product as a medical device.

Document should be from a Regulatory Authority.

Invoice with clear item description including HS Code/ Manufacturer Name &

Country of Origin.

Importer valid commercial record (CR).

Authorization letter from the legal manufacturer to the authorized representative to

market the device in the kingdom of Bahrain.

Country of Origin Certificate / Free Sale Certificate.

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(GMP) certificates from the Regulatory Authority in the Country of origin to the

legal manufacturer OR Quality management’s system certificates (example: ISO

13485) from a recognized certifying body.

Quality assurance Certificates (example: FDA, CE Mark, ISO 13485) from a

recognized certifying body along with a verification of its validity from the issuer.

Product intended use /Product Art work.

Device Classification based on level of Risk. (I, II, III…).

Product GMDNS* / UMDNS* Code Description

*Global Medical Device Nomenclature System.* Universal Medical Device

Nomenclature System.

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The process of Combined Medical Device Manual Approval can be simplified in the

following flowchart:

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7. Glossary

No. Terminology Definition

1

Manufacturer

Means any natural or legal person with

responsibility for design and manufacture of a

medical device with the intention of making it

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 another person.

2

Importer

Means any natural or legal person in the supply

chain who is the first to make medical device,

manufactured in another jurisdiction, available in

Bahrain.

3

Authorized Representative

The authorized agent from the manufacturer

through an authorization letter stating that it is the

exclusive distributer in the Kingdom of Bahrain

for marketing the imported medical devices.

4

HS code

The Harmonized Commodity Description and

Coding System generally referred to as

"Harmonized System" or simply "HS" is a

multipurpose international product nomenclature

developed by the World Customs Organization

(WCO).

The Harmonized Commodity Description and

Coding System (HS) is broad and is not structured

for medical devices field.

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No. Terminology Definition

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SFDA

Saudi Food and Drug Authority, which

regulates, oversee, and control food, drug,

medical devices, as well as to set mandatory

standard specifications thereof, whether they are

imported or locally manufactured.

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ISO 13485

International Organization for

Standardization Quality management systems

required for regulatory purposes is an (ISO)

standard published for the first time in 1996; it

represents the requirements for a

comprehensive quality management system for

the design and manufacture of medical devices.

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CE mark

Conformity European which literately means

“European Conformity”. The term initially used

was “EC Mark” and it was officially replaced

by “CE Marking” in the Directive 93/68/EEC in

1993, declaring that the product complies with

the essential requirements of the relevant

European health, safety and environmental

protection legislations.

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FDA

Food and Drug Administration , it is a federal

agency of the United States Department of

Health and Human Services, one of the United

States federal executive departments. The FDA

is responsible for protecting and

promoting public health through the control and

supervision of food safety, tobacco, dietary

supplements, prescription and over-the-

counter pharmaceutical drugs

(medications), vaccines, biopharmaceuticals, blo

od transfusions, medical

devices, electromagnetic radiation emitting

devices (ERED), cosmetics, animal foods &

feed[4] and veterinary products.

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Quality Assurance Certificate Verification

Means to check the validity of the quality

assurance certificate by contacting the certifying

body either by sending an email or online

through the website of the certifying body.

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No. Terminology Definition

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Certifying Body

The role of the certified Body is to conduct a

conformity assessment under the relevant EU

Directives. The conformity assessment usually

involves an audit of the manufacturer’s quality

system and depending upon the particular

classification of the device, a review of the

relevant technical documentation provided by the

manufacturer in support of the safety and

performance claims for the device.

Once the Certified Body has determined a

manufacturer has conformed to the relevant

assessment criteria, it issues a certificate to show

that the products assessed meet the requirements.

8. Annex

Please visit NHRA website for Combined Medical Device Checklist.

www.nhra.bh

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