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A3_Form A_1

A3 form A

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Lalit Saluja
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0% found this document useful (0 votes)
19 views

A3_Form A_1

A3 form A

Uploaded by

Lalit Saluja
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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FORM A

[See rules 4(1) and 8(1)]


(To be submitted in Duplicate with supporting documents as enclosures)
FORM OF APPLICATION FOR REGISTRATION OR RENEWAL OF REGISTRATION
OF A GENETIC COUNSELLING CENTRE/GENETIC LABORATORY/GENETIC
CLINIC/ULTRASOUND CLINIC/IMAGING CENTRE

1. Name, self attested Photo and address of the applicant

2. Full name and address of the facility sought to be registered

3. Type of ownership of Organisation: (Please tick below)


i. Individual
ii. Partnership
iii. company/
iv. co-operative
v. Any other to be specified.
(Other than Individual furnish/enclose copy of articles of association and names and addresses of
other persons responsible for management)

4. Type of Institution

i. Govt. Hospital
ii. Municipal Hospital
iii. Defence Hospital
iv. Public Hospital
v. Private Hospital
vi. Private Nursing Home
vii. Private Clinic
viii. Private Laboratory
ix. Sample Collection Centre for diagnostic techniques potential of sex selection/
determination
x. Any other to be Stated

5. Type of facility to be registered:


a) Genetic Counselling Centre
b) Genetic Laboratory
c) Genetic Clinic
d) Ultrasound clinic
e) Imaging centre
f) Hospital /Institute/ Nursing home
i. Genetic Counselling Centre
ii. Genetic Laboratory
iii. Genetic Clinic
iv. Ultrasound clinic
v. Imaging centre
(Pl tick the services jointly or in combination you sought to be registered as)

g) Genetic Clinic (Mobile)

6. Specific pre-conception and pre-natal diagnostic techniques/ procedures/tests/analysis with


potential for detection of sex during pregnancy or selection of sex before conception/
implantation, for which approval is sought
I. Invasive

a. Chorionic villus Sampling /Amniocentesis


i. Chromosomal studies
ii. Biochemical Studies
iii. Molecular Studies
b. Foetoscopy
c. Foetal biopsy
d. Cordocentesis
e. Pre-implantation gender diagnosis
f. Sample collection for diagnostic techniques potential of sex selection
and determination
g. Any other (to be specified)

II. Non-Invasive

a. Ultrasonography
b. MRI
c. CT Scan
d. NIPT
e. Sample collection for diagnostic techniques potential of sex
selection and determination
f. Any other (to be specified)

7. Specify the pre-implantation and pre-natal diagnostic, that would be provided in the Genetic
Counselling Centre for which registration is applied:
(a) Pre-implantation and post- implantation gender diagnosis
(b) Pre-natal and post natal diagnostic counselling
(c) Pre-implantation gender diagnosis
(d) Pre-natal diagnostic counselling
(e) Any other (to be specified)

8. Specify other techniques/ procedures/tests / analysis which would be provided in the facility
that do not have any potential for detection of sex during pregnancy or selection of sex before
implantation for which approval is sought:
a) Echocardiography
b) Ophthalmology
c) Urology
d) Veterinary proposes
e) Any other (to be specified)

9. Specify details of employees/ persons who will provide the services in the facility for which
registration is sought:
(Names, self attested photographs, Full contact details/ address,
qualifications/experience/training, registration number where applicable, details of
services the employees will provide and the details of equipment he/she will use for the
same in the facility, clearly specifying the consulting hours: enclose self attested copies of
all certificate as enclosures)

I. Genetic Counselling centre:


a. Gynaecologist
b. Paediatrician
c. Medical geneticist
d. Genetic councillor

II. Genetic Laboratory


a. Medical Geneticist
b. Laboratory technician
c. Registered Medical Practitioner (for Sperm Bank)

III. Genetic Clinic /Ultrasound clinic/imaging centre


a. Gynaecologist
b. Medical Geneticist (Clinical/Non-clinical)
c. Imaging specialist (Radiologist)
d. Registered Medical Practitioner with CBT certificate (as
prescribed under six months training Rules 2014)
e. Registered Medical Practitioner with six months training in
Abdomen-o Pelvic Ultrasound (as prescribed under six months
training Rules 2014)
f. Other Post Graduate Practitioners providing Ultrasound services
g. Genetic councillor
h. Laboratory technician

IV. Ultrasound clinic/imaging centre


a. Imaging specialist (Radiologist)
b. Registered Medical Practitioner with CBT certificate (as
prescribed under six months training Rules 2014)
c. Registered Medical Practitioner with six months training in
Abdomen-o Pelvic Ultrasound (as prescribed under six months
training Rules 2014)
d. Other Post Graduate Practitioners providing Ultrasound/
imaging services

10. Provide a self attested declaration that the facility for which the registration is sought as
Genetic Counselling Centre/ Genetic Laboratory/ Genetic Clinic/ Ultrasound clinic/imaging
centre qualifies in terms of requirements laid down in Rule 3.

11. 1. Specify details of equipment used to provide services, available in the facility, for which
registration is sought:
i. Operational
ii. Unused/ old /obsolete
iii. Any other (to be specified)

2. Specify details of equipment proposed to be acquired/ procured for providing services in


the facility, for which registration is sought:
(Make /model / year of purchase/ doctor who will use it and for what purpose/ e-waste disposal plan in case its disposal is
regulated by the any environmental laws/ or any other registration/ approval/license/ etc mandated by any other law:
enclose invoice, installation report or any other relevant documents related to equipment as enclosures)

12. In case of Genetic Clinic (Mobile) provide details as below:


a. Area of operation
b. Registration number of the vehicle
c. Number of machines installed
d. Diagnostic/ screening Tests offered
e. Other health and medical services as per Rule 3B(1)(b) (please
specify)
f. Any other (to be specified)

13. Details of other PNDT registrations of Genetic Counselling Centre/ Genetic Laboratory/ Genetic
Clinic/ Ultrasound clinic/imaging centre or any other similar facilities, registered in your name
(owners/ company/ organisation) in different districts, States / UTs/ countries.

14. Details of other PNDT registrations of Genetic Counselling Centre/ Genetic Laboratory/ Genetic
Clinic/ Ultrasound clinic/imaging centre or any other similar facilities in any other district,
state / UT, country, where your employees/ Doctors are also working.

15. Specify if the facility is linked to any other Genetic Counselling Centre/ Genetic Laboratory/
Genetic Clinic/ Ultrasound clinic/imaging centre for referral/ sample collection/any other
service(Pl specify), if yes please provide details (name address contact details) along with the
PNDT registration number of the same.
16. Specify the ART / Surrogacy registration number of the facility, if applicable:

i. ART Bank: _______________


ii. ART-I: ___________________
iii. ART-II:_____________________
iv. Surrogacy Clinic:_________________

17. For renewal applications only:


a) Registration No.
b) Date of issue and date of expiry of the existing certificate of registration.
c) Changes sought in the registration period under Rule 13
d) Details of unused/ old and obsolete equipment and their dispose plan

18. List of Enclosure


(Strike out whichever is not applicable or not necessary. Please attach a list of enclosures/supporting
documents attached to this application. All enclosures are to be authenticated by signature of the
applicant)

Date: (…………………………………..)

Place

Name, designation and


signature of the applicant or
person authorized to sign on behalf of the
organization to be registered

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