Medical Devices regulations

Kingdom of Bahrain

Eng. Nada Ghassan Al Sayegh

Engineering Safety Consultant

Content

• NHRA background

• Medical Device definition

• Medical Device regulations

• Statistics

• Medical device classification

• Medical device Importation

• Medical device Registration

• Recent -ongoing projects

• Q & A

لتنظالهيئة الوطنية NHRA Background المهن والخدمات يم

الصحية

An independent body established by law No 38 of 2009 and

undertook regulating the followings:

• Healthcare facilities

• Pharmaceutical products

• Medical devices

• Healthcare professional

• National Healthcare Accreditation

• Complaints handling

• Clinical research

Vision

Safe, trusted, high-quality and effective healthcare.

Mission

Setting appropriate standards, guidelines and policies in line with

international best practice and Ensuring compliance with these

standards

NHRA background

Medical Device regulations

2009 2015 2016 2017NHRA was initiated by law 38 , article 4,Clause B, Paragraph 8: to monitor all Healthcare facilities to ensure its commitments to the terms of licensing and assure the compliance of medical devices with international standards

Published 1st guideline of medical device regulation

Initiated Medical devices preapproval integration with customs through a fully integrated system OFOQ

Initiated Combined medical devices classification

Started Medical device local agent registration

• Regulations where adapted from an international well known standards followed by

many developed countries, such as:

1. WHO World Healthcare Organization

2. FDA Food and Drug Association

3. The European Commission

4. SFDA Saudi Food and Drug Administration

5. TGA Australian Government

6. MHRA Medicines and Healthcare Products Regulating Agency

7. ISO International Standards Organization

8. AHWP Asian Harmonized Working Party

9. PMDA Pharmaceuticals and Medical Device Agency

Medical Device regulations

Medical Device definition

• Medical Device: means all products, except medicines, used in healthcare for the

diagnosis, prevention, monitoring or treatment of illness or disability that does not

achieve its action by pharmacological, immunological or metabolic means.

• 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.

Combined medical device (Borderline

products):

• Term used mostly for the classification criteria, its actually a

Medical device with a pharmaceutical HS code

• Means a medical device that is mixed with pharmaceutical or

chemical materials and does not achieve its action by

pharmacological, immunological or metabolic means, used for

prevention of illness.

Important Regulations

• Bahrain is an open market however each importer must have a

valid CR (commercial Registration) to import/export Medical

device

• All combined medical devices must be imported by local

agents from the manufacturer

• Pre-approval is required before shipping

• Approval duration from 24hrs to 2 weeks . If the documents

are as requested

• NHRA regulates the importation of Medical devices Class II

and III only

Statistics

• A total of (7835) shipments were imported to Bahrain in 2016, with a total price of medical devices imported from class II and III around 19,145,181 Bahrain Dinars.

• 1648 Total registration certificate issued in 2017

Statistics

Statistics

Medical device Classification

Combined medical devices

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:

– Product is classified in country of origin as medical

devices.

– Two of the 22 reference countries classify the product as a

Medical device

– The product is FDA approved or CE marked.

– Product medical claim falls under the definition of medical

device

– Product principle intended action is physical or mechanical.

Combined medical devices

Classification • All Combined Medical devices registered before April 2016

will be reviewed once are tended to be renewed to match with

the new classification requirement stated above.

• All registered combined medical devices that were classified

by the product classification team members, can be renewed

without reclassification

• In Sep 2017 the guideline was fully implemented on all CMD

Medical Devices importation

Medical Devices ImportationBeforeCurrent

Medical Devices Importation

• Customs Affairs - Ministry of Interior (MOI) has

developed an online application (called OFOQ)

to monitor and control all shipments accessing

the Kingdom of Bahrain ports

• Many governmental parties have initiated control

process through OFOQ, e.g. Supreme Council of

Environment

• Requests can be submitted 24/7

• HS codes where narrowed down to Class II and

III

HS CODE LIST OF COMBINED MEDICAL DEVICE (MANUAL APPROVAL)أو الكميائيةنية دالمواد الصيلبابالهيئة للمستلزمات الطبية المدمجة صة الخامركية الجالبنود

للموافقة اليدوية) (

29362100 29372300 30021000 29372900

29362200 29362600 29371100 29375000

29362300 29362700 29371200 29379000

29362400 29362800 29371900 30012000

33049990 29362900 29372100 30031000

29369000 29372200 30019000 30044000

30022000 30032000 30041000 30045000

30029010 30033100 30042000 30049010

30029020 30033900 30043100 30049090

30029090 30034000 30043200 30063000

30039000 30043900 30066000

MEDICAL DEVICES HS CODE (ONLINE APPROVAL- OFOQ)بالهيئة للمستلزمات الطبيةاصة الخمركية الجالبنود

( على برنامج افقللموافقة (

HS code HS code HS code HS code

40 17 00 20 90 18 13 00 94 02 10 10 90 21 50 00

87 05 90 80 90 18 12 00 90 18 90 90 90 21 40 00

84 19 20 00 90 18 11 00 90 18 90 60 90 21 39 10

90 06 30 00 90 21 10 20 90 18 90 50 90 21 39 20

90 18 39 90 90 21 39 90 90 18 90 40 90 25 80 20

90 18 39 30 90 21 31 00 90 18 90 30 90 22 90 00

90 18 39 20 90 21 29 00 90 18 90 20 90 01 30 00

90 18 39 10 90 21 21 00 90 18 90 10 90 21 90 90

90 18 32 00 90 21 10 90 90 18 50 90 90 26 10 00

90 18 31 90 90 21 10 40 90 18 50 20 28 44 30 10

90 18 31 40 90 22 30 00 90 18 50 10 28 44 30 90

90 18 31 30 90 22 29 00 90 18 49 90 28 44 40 10

90 18 31 20 90 22 21 00 90 18 49 20 28 44 40 90

90 18 20 00 90 22 19 90 90 18 41 00 28 44 50 00

90 18 19 90 90 22 14 00 90 19 20 00 28 45 10 00

90 18 19 20 90 22 13 00 90 19 10 00 28 44 20 10

90 18 19 10 90 22 12 00 90 21 90 90 84 01 10 00

90 18 14 00 90 27 80 10 90 21 90 10 84 01 40 00

28 44 10 10 84 01 20 00 90 30 10 00

Medical Devices Importation• The Harmonized Commodity Description and Coding System

(HS) is a international product nomenclature developed by

the World Customs Organization (WCO)

OFOQ Importation Requirements

1. Commercial invoice; including the HS code, manufacturer name, clear description of the item and its origin.

2. Country of origin certificate or SFDA (Saudi Food and Drug Administration) or a competent authority registration or free sale certificate (FSC).

3. Quality Assurance Certificates (FDA, CE Mark, ISO 13485) Must be verified

4. GMP or ISO 13485 for combined medical devices. Must be verified

5. Product technical specification; for certain devices a further details might be requested.

6. Local purchase order for controlled medical devices.

CMD Importation Requirements:-1.Product is classified in country of origin as medical devices. Document should be from the Regulatory

Authority in the Country of origin to the legal manufacturer, excluding Lab reagents

2.Two of the reference countries classifies the product as a medical device. Document should be from a

Regulatory Authrity , excluding Lab regaents

3.Invoice with clear item description including HS Code/ Manufacturer Name & Country of Origin.

4.Importer valid commercial record (CR).

5.Authorization letter from the legal manufacturer to the local agent to market the device in the kingdom of

Bahrain .

6.(GMP) certificates from the Regulatory Authrity in the Countriy of origin to the legal manufacturer OR

Quality management’s system certificates (example: ISO 13485) from a recognised certifying body.

7.Quality assurance Certificates (example: FDA, CE Mark, ISO 13485) from a recognised certifying body

along with a verification of its validity from the issuer.

8.Product intended use /Product Art work.

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

10.Product GMDNS* / UMDNS* Code Description

*Global Medical Device Nomenclature System.* Universal Medical Device Nomenclature System.

Note: All documents must be written in Arabic or English , documents must be clear and easy to read

Medical device Registration • Phase one: local agent

registration, renewed once every 5 years

• Phase two: link product to the agent by registering product lines, based on the QAC validity

• Bundling method will be similar to SFDA

Certificate

• Company • Product

Member in the Technical

committee TC11 for

medical device

Standards

Member in the Medical device

Central registration

Ongoing projects

All SFDA registered

Medical devices can be

registered in NHRA

without resubmitting the

same documents

❖ GCC harmonization

Ongoing projects

❖ Outsourcing -QAC validation

Questions!!