Application Form for Listing of Medical Device Establishment

Listing of Medical Device Establishment Application Form

Step 1 of 2

Details of Medical Devices Establishment

Registered Company Name(Required)

Name if Trading Under other Business Name

Line of Trade (Manufacturer, Distributor, Importer, Retailer Etc.)(Required)

Physical Address (Location of Premises)(Required)

Postal Address(Required)

Email(Required)

Phone Number(Required)

Destination Zone(Required)

Village / Town(Required)

other(specify)

Current Establishment License Details

Trade License Number(Required)

Expiry Date of Trade License(Required)

List any existing License with BoMRA

Expiry Date of BoMRA License (if applicable)

Medical Devices including IVDs Risk Classification being Dealt with (A, B, C, D)

Medical Devices

Medical risk class

Class A

Class B

Class C

Class D

Class A

Class B

Class C

Class D

Specify

IVDs

IVD class risk

Class A

Class B

Class C

Class D

Class A

Class B

Class C

Class D

Specify

Details of Contact Person

Full Name(Required)

Email(Required)

Position in the Company(Required)

Details of Key Personnel

Full Name(Required)

Position in the Company(Required)

Email(Required)

Phone Number(Required)

Qualification

Professional Registration e.g. BHPC or equivalent

Declaration by Applicant

I, the undersigned, certify that all the information above concerning the application for listing of the medical devices establishment is correct and true.

Name(Required)

Position in company(Required)

Date(Required)

Signature (initial/ digital)(Required)

Attach relevant documents

Drop files here or

Max. file size: 200 MB.

This form should be submitted along with the relevant documents e.g. licenses, certificate etc.

You can also email supporting documents to medicaldevices.services@bomra.co.bw and rmu@bomra.co.bw.

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ABOUT US

Corporate Governance

PEOPLE

STRATEGIC PARTNERSHIP

REGULATIONS

ACT

PUBLICATIONS

EVENTS

GALLERY

NEWS

Tenders

Careers

Report-an-Issue

Register

Repositories

ABOUT US

Corporate Governance

PEOPLE

STRATEGIC PARTNERSHIP

REGULATIONS

ACT

PUBLICATIONS

EVENTS

GALLERY

NEWS

Tenders

Careers

Report-an-Issue

Register

Repositories

Listing of Medical Device Establishment Application Form

Details of Medical Devices Establishment

Current Establishment License Details

Medical Devices including IVDs Risk Classification being Dealt with (A, B, C, D)

Medical Devices

IVDs

Details of Contact Person

Details of Key Personnel

Declaration by Applicant

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