The field of medicine known as obstetrics and gynaecology is dedicated to the care of women during pregnancy and childbirth, as well as the diagnosis and treatment of conditions affecting the female reproductive system. It also focuses on various conditions affecting the health of women, including infertility, menopause, and hormonal difficulties. It also goes by the name OB-GYN. The Central Drugs Standard Control Organization, also called CDSCO, is a regulatory organisation for the Indian medical device industry under the Drugs and Cosmetics Act of 1940. The CDSCO is the national governing body for Obstetrical and Gynaecological Medical Devices. The Indian CDSCO is administered and governed by the Directorate General of Health Services or DGHS under the Ministry of Health & Family Welfare.
It performs similar duties to those of the National Medical Products Administration (NMPA) of China, the European Medicines Agency (EMA), the PMDA of Japan, the Food & Drug Administration (FDA) of the United States, the Medicines and Healthcare Products Regulatory Agency of the United Kingdom, and the European Medicines Agency (EMA) of the European Union. The Act and Rules delegate numerous obligations for drug and cosmetic regulation in India to the Central and State Regulators. CDSCO is the Central Drug Control Organization, which performs the tasks entrusted to the Central Government under the Act. It also advises and coordinates the actions of state drug control organisations. CDSCO and state regulators work together to provide licences for certain specialised categories of essential drugs such as vaccines, blood and blood products, IV fluids, and sera.
The status of a medical device was enlarged beyond the 23 previously notified medical devices on April 1, 2020, requiring that all medical devices be registered under The Drugs and Cosmetics Act of 1940. Beginning October 1, 2022, all Class A and B medical devices must be imported with an Import License. All remaining Class C and D devices that have yet to be notified will require Import Licenses by October 1, 2023. In this article, we will talk about CDSCO Registration for Obstetrical and Gynaecological Medical Devices.
Classification of Medical Devices Pertaining To Obstetrical and Gynaecological Medical Devices
The phrase “medical device” appears in Section 3(b)(iv) of the Drugs and Cosmetics Act of 1940. Prior to 2005, India had no regulations governing medical devices. Today, however, there are registration processes for specific medical device types that are covered by the Medical Device Rules. While the list of regulated products is exhaustive, the CDSCO occasionally adds products to the list. Before marketing your product in India, you must first ascertain whether it is governed by the CDSCO.
Depending on the level of risk, medical devices are divided into four categories: A, B, C, and D. The device classification determines the CDSCO fees for application processing. No matter how the device is classified, the application procedure takes 6 to 9 months. Applications for devices that are unable to recognise a predicate device will be deemed “Innovative” and probably take more time. The list of OB-GYN-related medical devices and their risk categories is provided below.
|Medical Device Name||Risk Class|
|Abdominal decompression chamber||C|
|Abdominal decompression chamber pump||C|
|Abortion suction system manual aspirator||B|
|Birthing bed/table, powered||A|
|Cardiotocography telemetric monitoring system||C|
|Cardiotocography telemetric monitoring system receiver||C|
|Cardiotocography telemetric monitoring system transmitter||C|
|Cervical anaesthesia kit||B|
|Cervical anaesthesia needle, reusable or single use||B|
|Contraceptive cervical cap, reusable or single use||C|
|Endocervical specimen collection kit, no additive||B|
|Endometrial biopsy curette, reusable||B|
|Endometrial biopsy curette, single use/disposable||B|
|Endometrial biopsy kit||B|
|Endometrial cytology brush||B|
|Fallopian tube biopsy everting-balloon catheter||B|
|Fallopian tube catheterisation kit||B|
|Fallopian tube insufflator||B|
|Fallopian tube occlusion insert||D|
|Fixed-diameter cervical dil||B|
|Fixed-diameter cervical dilator, single-use/disposable||B|
|Flexible fibreoptic culdoscope||B|
|Flexible fibreoptic hysteroscope||B|
|Flexible fibreoptic laparoscope||B|
|Flexible fibreoptic mammary ductoscope||B|
|Flexible fibreoptic salpingoscope||B|
|Flexible ultrasound laparoscope||B|
|Flexible video culdoscope||B|
|Flexible video hysteroscope||B|
|Flexible video laparoscope||B|
|Flexible video mammary ductoscope||B|
|Flexible video salpingoscope||B|
|Foetal acoustic stimulator||B|
|Foetal bladder shunt||C|
|Foetal blood sampler||B|
|Foetal cardiac monitor||C|
|Foetal pleuro-amniotic catheter||C|
|Foetal scalp electrode, clip||C|
|Foetal vacuum extraction cup, reusable/single use||B|
|Foetal vacuum extraction system monito||B|
|Foetal vacuum extraction system, manual, reusable/single use||B|
|Foetal vacuum extraction system, pneumatic||B|
|Foetal/maternal multiple physiological parameter simulation kit||B|
|Foetal/maternal multiple physiological parameter simulator||B|
|Gynaecological examination/treatment table||A|
|Gynaecological operating table top||A|
|Gynaecological operating table, electrohydraulic or electromechanical/hydraulic||A|
|Gynaecological scissors, reusable||B|
|Gynaecological scissors, single use/disposable||B|
|Gynaecological surgical microscope||A|
|Hysteroscopic irrigation/insufflation system||B|
|Intrauterine cannula, reusable||B|
|Intrauterine cannula, single use/disposable||B|
|Intrauterine haemostatic balloon catheter||B|
|Intrauterine haemostatic suction catheter||B|
|Intrauterine imaging medium catheter||B|
|Intrauterine imaging medium catheterisation kit||B|
|Laparoscope laser coupler||B|
|Laparoscope laser adaptor||A|
|Laparoscope system, reusable or single use||B|
|Manual expandable cervical dilator||B|
|Mechanical foetal heart simulator||B|
|Motorized laparoscopic forceps||B|
|Papanicolaou smear kit or Endometrial sampling kit||B|
|Pelvic examination kit||B|
|Pudendal anaesthesia kit||B|
|Rigid fibreoptic hysteroscope||B|
|Rigid mammary ductoscope||B|
|Rigid optical laparoscope||B|
|Rigid ultrasound laparoscope||B|
|Rigid video hysteroscope||B|
|Rigid video laparoscope||B|
|Suprapubic needle, surgical, reusable||B|
|Suprapubic needle, surgical, single use/ disposable||B|
|Uterine manipulator cervical cup/transilluminator||B|
|Uterine manipulator, reusable||B|
|Uterine manipulator, single use/disposable||B|
|Uterine probe, reusable||B|
|Uterine probe, single use/disposable||B|
|Vaginal applicator, reusable or single use||A|
|Vaginal dilator, reusable||B|
|Vaginal dilator, single use/ disposable||B|
|Vaginal douche, reusable or single use||B|
|Viscera retention paddle or Visceral retainer||B|
|Amniotic membrane perforator, reusable||A|
|Catheter-tip transducer, pressure||B|
|Foetal Doppler system||C|
|Foetal Doppler system probe||C|
|Preservation medium for human semen||C|
|Sperm cryopreservation medium||C|
|Vitrification freezing kit||C|
|Vitrification Thawing/Warming kit||C|
|Gamete and embryo retrieval, storage & transfer medium||C|
|Polyvinylpyrrolidone (PVP) Solution||C|
|Sperm Separation Medium||B|
|Sperm processing media||C|
|Water for Assisted Reproductive Technologies||B|
|In-Vitro embryo Culture medium, through day 5/6 of development||C|
|In-Vitro embryo culture medium, through day 3 of development||C|
|Protein supplement for in vitro embryo culture||B|
|Oil for embryo culture||B|
Who Can Register Under CDSCO?
The applicants listed below can register via the CDSCO web portal to register their Obstetrical and Gynaecological Medical Devices:
- Indian Agents
- Foreign Enterprises holding Indian Subsidiary
Purposes for Which CDSCO Registration Can Be Obtained
The primary objective of the Central Drug Standard Control Organization is to create CDSCO license guidelines that guarantee:
- No animals are harmed or put through testing while making cosmetic items, nor are heavy metals and toxins used.
- The product is secure for general consumption.
- Only drugs and medical equipment that have received CDSCO approval may be imported.
CDSCO can grant registration for the following:
- Cosmetics Registration
- Import or Manufacture of drugs
- Export NOC (Zone)
- Test License
- Ethics Committee Registration
- Formulation R&D Organisation
- Blood Bank Registration
- Blood Product Registration
- Dual Use NOC (Trader)
- BA/BE Approved Sites
- Sponsors (BA/BE and CT)
What is the Eligibility Criteria for CDSCO Registration for Obstetrical and Gynaecological Medical Devices?
According to CDSCO rules, the parties listed below are eligible for CDSCO registration certificates for Obstetrical and Gynaecological Medical Devices:
- A manufacturer should have a company with a registered office operating in the country (India).
- Any authorised agent of the manufacturer.
- A subsidiary company of that manufacturer operating in the country (India).
- Any other importer who wishes to deal in the business of importing cosmetic products from other countries.
Therefore, CDSCO registration is required for all of the aforementioned.
What Documents Are Required For CDSCO Registration For Obstetrical And Gynaecological Medical Devices?
Following is the list of documents needed for CDSCO registration for Obstetrical and Gynaecological Medical Devices:
- Application form for registration;
- Challan TR6;
- ISO 13485;
- Power of Attorney;
- An Undertaking stating that only accurate information is provided;
- Certificate of Quality Assurance;
- C.E. Design Accreditation;
- Declaration of Conformity;
- Schedule D(I);
- Master Plant File;
- Device Master File or DMF;
- Free sale certificate or FSC.
Process of CDSCO Registration for Obstetrical and Gynaecological Medical Devices
Applications for both notified and non-notified medical devices must be filed via the online SUGAM portal, which CDSCO uses to manage applications.
Mentioned below is a step-by-step procedure for CDSCO registration for Obstetrical and Gynaecological Medical Devices:
- First step is to know whether your product requires registration.
- Appoint an authorised Indian agent for CDSCO registration for OB-GYN medical devices.
Eligibility to be an authorised Indian agent:
- Must be a Resident of India;
- Must have years of experience in the healthcare industry;
- Must hold Power of Attorney (PoA) to submit medical device registration documents to CDSCO.
- Must hold wholesale drug licenses in forms 20B & 21B.
- Submit the application along with the required documents.
- After the documents for Registration are submitted, CDSCO will get back to the Indian Agent (Authorised Respresntative) with a query letter (if any). If the responses or answers given by the Indian Agent are satisfactory to CDSCO, the licence will be granted.
- The registration certificate for Obstetrical and Gynaecological Medical Devices is valid for a term of three years.
The Indian health sector is expanding briskly and is starting to appeal to makers of medical devices. The Drugs and Cosmetics Act of 1940 establishes rules for the CDSCO. In India, CDSCO is in charge of overseeing medical device regulation. As a result, manufacturers of OB-GYN medical devices must register with CDSCO before marketing their products in the market.
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