Date: 29 October 2002
Dear Mr. Farooq. A. Khan,
MEDICAL DEVICES REGULATIONS 2002: REGULATION
19
Registration of Persons Placing General Medical Devices on the
Market
Thank you for informing the Competent Authority of the details
of Manufacturers
Name:- Arsa Enterprises) located at Manufacturers
Address:- Pasrur Road Sialkot Pakistan
for whom you are acting as the authorised representative and for
supplying the medical device information.
Your registration has been recorded based on your declaration
that you have determined that the device(s) fall within the definition
of “medical device”, and that you have classified
it/them as falling within Regulation 19 taking into account the
intended purpose(s) and mode(s) of action. In accepting your registration,
I should make clear that the Competent Authority does not examine
each individual notification and therefore cannot and does not
necessarily endorse these determinations. Neither does this letter
represent any form of accreditation or approval by the UK Competent
Authority.
Your registration is based upon your declaration on the RG2 form
and means that:
For Manufacturers of Class I medical devices, Assemblers,
and Sterilisers
You should now be operating under the Medical Devices Directive
and the above Regulations for the products you asked us to register,
by fully complying with the essential requirement, CE marking
those products or labelling them as such.
For Manufacturers of Custom-made devices
You should be ready to claim compliance with the Directive and
Regulations and should be manufacturing custom-made devices in
accordance with their requirements.
If you stop placing devices on the market or if you are
not complying with the Regulations you should inform us so that
we can amend our records. You should be aware that it is an offence
to place on the market CE marked devices that do not comply with
the regulation.
The information you provided has been recorded against the reference
number shown at the top of this letter, which we ask you to quote
in all future correspondence and communications.
Please inform us of any changes to:
- The company information
- Additional generic groups of devices (not individual products
within an existing generic group)
- Discontinuation of a generic group of devices.
Please use RG2, the Registration form, to tell us about any of
these changes.
Thank you for registering the following generic groups of devices:
Class I
Devices:
Dental Instruments ( Re- Usable & Non- Powered)
Surgical Instruments ( Re-Usable and Non- Powered)
Custom
Made Devices
None
Products
Covered By Article 12:
None
Should you have any queries regarding your registration please
contact us on the telephone number given at the top of this letter.
Yours sincerely
Vanessa Hernandez
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