CDSCO Registration for Obstetrical and Gynaecological Medical Devices

CDSCO Registration for Obstetrical and Gynaecological Medical Devices


Obstetrics and Gynaecology, often referred to as OB-GYN, encompass medical care related to pregnancy, childbirth, and female reproductive health. The regulatory framework in India for medical devices in this field is overseen by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act of 1940. This article outlines the CDSCO registration process for Obstetrical and Gynaecological Medical Devices, classifying them based on risk and providing insights into eligibility, documentation, and the registration procedure.

Regulatory Landscape

The CDSCO, operating under the Directorate General of Health Services (DGHS) within the Ministry of Health & Family Welfare, serves as the national governing body for medical devices in India. Comparable to regulatory bodies worldwide, such as the FDA in the United States and the European Medicines Agency (EMA), the CDSCO ensures compliance with standards, issues licenses, and collaborates with state regulators for comprehensive oversight.

Medical Device Classification

Medical devices are categorized into four classes (A, B, C, and D) based on risk. The classification impacts CDSCO application fees and processing timelines:

With the expansion of the definition of medical devices in 2020, all such devices must now be registered under the Drugs and Cosmetics Act. The classification of medical devices, ranging from Class A to D based on risk, dictates the CDSCO application fees and processing timelines.

  • Class A and B Devices: Import requires a license from October 1, 2022.
  • Class C and D Devices: Import licensing mandatory from October 1, 2023.

Navigating Obstetrical and Gynaecological Device Registration

Understanding Device Classification

The CDSCO classifies medical devices based on risk, with implications for the regulatory process:

  1. Class A: Low-risk devices.
  2. Class B: Low to moderate risk.
  3. Class C: Moderate to high risk.
  4. Class D: High-risk devices.

Application Process and Timelines

Regardless of classification, the CDSCO application process takes 6 to 9 months. Devices without a predicate device for comparison are deemed “Innovative” and may experience extended processing times.

OB-GYN Device Classification and Examples

To market obstetrical and gynaecological medical devices in India, understanding the medical device classification is paramount. Here’s a glimpse:

  1. Class A: Examples include menstrual cups.
  2. Class B: Intrauterine devices (IUDs) fall into this category.
  3. Class C: Devices like fetal heart monitors fall into the moderate to high-risk category.
  4. Class D: High-risk devices may include assisted reproductive technology devices.
  Medical Device Name Risk Class
Abdominal decompression chamberC
Abdominal decompression chamber pumpC
Abortion suction system manual aspiratorB
Birthing bed/table, poweredA
Cardiotocograph transducerC
Cardiotocography telemetric monitoring systemC
Cardiotocography telemetric monitoring system receiverC
Cardiotocography telemetric monitoring system transmitterC
Cervical anaesthesia kitB
Cervical anaesthesia needle, reusable or single useB
Contraceptive cervical cap, reusable or single useC
Contraceptive spermicideC
Contraceptive spongeC
Diaphragm pessaryC
Endocervical aspiratorB
Endocervical specimen collection kit, no additiveB
Endometrial biopsy curette, reusableB
Endometrial biopsy curette, single use/disposableB
Endometrial biopsy kitB
Endometrial cytology brushB
Fallopian tube biopsy everting-balloon catheterB
Fallopian tube catheterisation kitB
Fallopian tube insufflatorB
Fallopian tube occlusion insertD
Fixed-diameter cervical dilB
Fixed-diameter cervical dilator, single-use/disposableB
Flexible fibreoptic culdoscopeB
Flexible fibreoptic hysteroscopeB
Flexible fibreoptic laparoscopeB
Flexible fibreoptic mammary ductoscopeB
Flexible fibreoptic salpingoscopeB
Flexible ultrasound laparoscopeB
Flexible video culdoscopeB
Flexible video hysteroscopeB
Flexible video laparoscopeB
Flexible video mammary ductoscopeB
Flexible video salpingoscopeB
Foetal acoustic stimulatorB
Foetal bladder shuntC
Foetal blood samplerB
Foetal cardiac monitorC
Foetal pleuro-amniotic catheterC
Foetal scalp electrode, clipC
Foetal stethoscopeA
Foetal vacuum extraction cup, reusable/single useB
Foetal vacuum extraction system monitoB
Foetal vacuum extraction system, manual, reusable/single useB
Foetal vacuum extraction system, pneumaticB
Foetal/maternal multiple physiological parameter simulation kitB
Foetal/maternal multiple physiological parameter simulatorB
Gynaecological bibA
Gynaecological examination/treatment tableA
Gynaecological operating table topA
Gynaecological operating table, electrohydraulic or electromechanical/hydraulicA
Gynaecological scissors, reusableB
Gynaecological scissors, single use/disposableB
Gynaecological surgical microscopeA
Heel stirrupA
Hysteroscopic insufflatorB
Hysteroscopic irrigation/insufflation systemB
Intrauterine cannula, reusableB
Intrauterine cannula, single use/disposableB
Intrauterine haemostatic balloon catheterB
Intrauterine haemostatic suction catheterB
Intrauterine imaging medium catheterB
Intrauterine imaging medium catheterisation kitB
Laparoscope laser couplerB
Laparoscope laser adaptorA
Laparoscope systemB
Laparoscope system, reusable or single useB
Manual expandable cervical dilatorB
Mechanical foetal heart simulatorB
Motorized laparoscopic forcepsB
Papanicolaou smear kit or Endometrial sampling kitB
Pelvic examination kitB
Perineal warmerB
Pudendal anaesthesia kitB
Rigid culdoscopeB
Rigid fibreoptic hysteroscopeB
Rigid mammary ductoscopeB
Rigid optical laparoscopeB
Rigid salpingoscopeB
Rigid ultrasound laparoscopeB
Rigid video hysteroscopeB
Rigid video laparoscopeB
Suprapubic needle, surgical, reusableB
Suprapubic needle, surgical, single use/ disposableB
Umbilical ligatorA
Uterine injectorB
Uterine manipulator cervical cup/transilluminatorB
Uterine manipulator, reusableB
Uterine manipulator, single use/disposableB
Uterine packerA
Uterine probe, reusableB
Uterine probe, single use/disposableB
Uterus-supporting pessaryB
Vaginal applicator, reusable or single useA
Vaginal dilator, reusableB
Vaginal dilator, single use/ disposableB
Vaginal douche, reusable or single useB
Viscera retention paddle or Visceral retainerB
Breast transilluminatorC
Amniotic membrane perforator, reusableA
Amniotome, reusableB
Bladder-supporting pessaryB
Catheter-tip transducer, pressureB
Foetal Doppler systemC
Foetal Doppler system probeC
Preservation medium for human semenC
Sperm cryopreservation mediumC
Vitrification freezing kitC
Vitrification Thawing/Warming kitC
Handling mediumC
Gamete and embryo retrieval, storage & transfer mediumC
Hyaluronidase solutionC
Polyvinylpyrrolidone (PVP) SolutionC
Sperm Separation MediumB
Sperm processing mediaC
Water for Assisted Reproductive TechnologiesB
In-Vitro embryo Culture medium, through day 5/6 of developmentC
In-Vitro embryo culture medium, through day 3 of developmentC
Protein supplement for in vitro embryo cultureB
Oil for embryo cultureB
Menstrual CupB

Who Can Register Under CDSCO for Obstetrical and Gynaecological Medical Devices?

Entities eligible to register Obstetrical and Gynaecological Medical Devices with CDSCO include:

  • Importers
  • Indian Agents
  • Foreign Enterprises with Indian Subsidiaries
  • Corporates

Purposes of CDSCO Registration for Obstetrical and Gynaecological Medical Devices

CDSCO registration ensures compliance with guidelines, including:

  • No harm to animals in cosmetic product testing.
  • Safety for general consumption.
  • Importation of only CDSCO-approved drugs and medical equipment.

CDSCO can grant registration for various purposes, such as Cosmetics Registration, Import or Manufacture of drugs, Export NOC, Test License, Ethics Committee Registration, and more.

Eligibility Criteria for CDSCO Registration Certificate for Obstetrical and Gynaecological Medical Devices

Eligible parties for CDSCO registration certificates for Obstetrical and Gynaecological Medical Devices include:

  • Manufacturers with a registered office in India.
  • Authorized agents of manufacturers.
  • Subsidiary companies of manufacturers in India.
  • Other importers dealing in cosmetic products.

Required Documents for CDSCO Registration Certification for Obstetrical and Gynaecological Medical Devices

Essential documents for CDSCO registration include:

  • Application form
  • Challan TR6
  • ISO 13485
  • Power of Attorney
  • Undertaking of providing accurate information
  • Certificate of Quality Assurance
  • C.E. Design Accreditation
  • Declaration of Conformity
  • Schedule D(I)
  • Master Plant File
  • Device Master File (DMF)
  • Free Sale Certificate (FSC)

Obstetrical and Gynaecological Medical Devices – CDSCO Registration Process

The application process involves the following steps:

  1. Product Classification: Determine if registration is required.
  2. Appointment of Indian Agent: Appoint an authorized Indian agent.
  3. Application Submission: Submit the application and required documents.
  4. Query Resolution: Respond to queries from CDSCO, if any.
  5. License Issuance: Upon satisfactory responses, CDSCO grants the license.
  6. Validity: The registration certificate is valid for three years.


As the Indian healthcare sector expands, manufacturers of Obstetrical and Gynaecological Medical Devices must navigate the CDSCO registration process. Adhering to the rules outlined in the Drugs and Cosmetics Act of 1940, CDSCO ensures the safety and efficacy of medical devices in India. Manufacturers, importers, and agents must collaborate to meet the regulatory requirements and contribute to the growth of the healthcare industry in the country.

Leave a Comment

Your email address will not be published. Required fields are marked *