Overview of CDSCO
Central Drug Standard Control Organization (CDSCO) is India’s regulatory body regulating different medical devices in India. Before any medical device is marketed in India, it needs to get approval from the CDSCO; otherwise, it is impossible to sell and distribute it. CDSCO follows the rules, acts, and standards to regulate the medical device market. Each year thousands of applicants apply for the registration. That’s why the rules are getting stringent nowadays so that only devices get marketed which benefit the population get them. CDSCO released a list of non-notified medical device that requires registration, and one such medical device is a microscope.
In the article below, NKG will discuss the Microscope and how to apply for a license to market it in India.
What is a microscope
Microscope as a medical device – A Microscope is a device used to view objects that are too small and cannot be observed with the naked eye. They are used to examine the tissue and blood samples to diagnose the disease and condition and sometimes help perform the surgical procedure. Given below are different types of microscopes used by healthcare professionals.
Types of Microscopes
CLASS A (non-measuring & non-sterile):
- ENT surgical microscope – The ENT surgical microscope is mentioned in the list of medical devices used for ENT. It is intended to magnify the minute structures challenging to see through the naked eye (e.g., nerves, vessels) in the ear, nose, and throat (ENT) performance. It is also used in surgery requiring high magnification and adjustable focusing.
- Surgical Microscope and Accessories – The surgical Microscope and accessories are mentioned in the list of medical devices for dermatology and surgery. It is an AC-powered device intended for surgery to provide a magnified view of the surgical field.
- Gynecological surgical Microscope – The Gynecological surgical Microscope is mentioned in the list of medical devices for obstetrical and gynecology. It improves visualization of anatomical structures via transmitted light during gynecological surgery (e.g., on the fallopian tubes).
CLASS B:
- Neurosurgical Microscope- A neurological microscope is mentioned in the list of medical devices used in neurology. It is designed to magnify minute structures within the neurological fields for surgery, typically the brain or spine or surroundings in the performance of neurological surgical procedures which require high magnification by transmitted light.
- Colposcope – Coloscopy is mentioned in the list of medical devices for obstetrical and gynecology. It is a special microscope to examine female genital organs (e.g., vagina, cervix).
Registration Process of the Class A Microscope in India:
Step 1: Classify if the Microscope falls under Class A nonsterile non-measuring medical device.
Step 2: If yes, the applicant must register their Microscope from the “add non-regulatory device” section in the SUGAM portal.
Step 3: The applicant must select the purpose, i.e., whether they are the importer or the manufacturer.
Step 4 – The applicant must upload the documents per their category.
Step 5: After uploading the documents, a “Registration number” will be generated that needs to be added to the label for sale in the Indian market.
Documents required for Microscope registration in India:
For the manufacturer of hospital bed | For importers of hospital bed |
Name and address of the manufacturer of the hospital beds. | Name and address of the importer and manufacturing site where hospital beds are manufactured. |
Details of Class A medical device that comes under the non-sterile and non-measuring Class | Details of Class A medical device that comes under the non-sterile and non-measuring Class |
An undertaking from the manufacturer confirming that the Microscope belongs to a Class A non-sterile and non-measuring medical device. | An undertaking from the importer confirming that the Microscope belongs to a Class A non-sterile and non-measuring medical device. |
The self-certificate from the manufacturer to confirm that the product complies with the essential principles and standards specified in rule GSR 777. | The self-certificate from the importer to confirm that the product complies with the essential principles and standards specified in rule GSR 777. |
An undertaking from manufacturing states that the details mentioned by the manufacturer are authentic. | Self-attested copy of the manufacturing site situated overseas in the origin country issued by the competent authority or Free Sale Certificate issued by the National Regulatory Authority. |
| An undertaking from the importer stating that the details mentioned by the manufacturer are authentic |
Note: No audit of the manufacturing site shall be necessary before granting a license or loan license to manufacture for sale or distribution of Class A medical device.
The applicant shall maintain the manufacturing or import records and their sale and distribution. When requested by the licensing authority, the applicant must provide the records for verification failure, which can lead to the cancellation of the license to sell hospital beds (Class A non-sterile non-measuring medical devices).
Registration Process of the Class B Microscope in India
Applicant type | Application | License | Fees |
Manufacturing License | Form MD-3 | Form MD- 5 |
For one site INR 5000 and INR 500 for each distinct device |
Manufacturer (Loan License) | Form MD- 4 | Form MD- 6 | |
Import License | Form MD- 14 | Form MD- 15 | For Class B $2000 (one site); $1000 (for each distinct medical device) |
Documents required
For manufacturers:
- Cover letter
- Fees
- Constitution details of the manufacturing firm.
- The Establishment /Site Ownership/Tenancy Agreement.
- Duly notarized valid copies of Quality Certificate in respect to manufacturing site(s), if any;
- Copy of Certificate supporting quality management system (ISO: 13485), if any;
- Plant master file
- Device master file
- Test license (for the domestic manufacturer)
- Undertaking that the manufacturing site complies with the quality management system.
For the import license authorized agent needs to submit the following documents:
- Cover letter
- Power of attorney
- Wholesale license
- Free sale certificate from the country of origin.
- Free sale certificate from any country, namely USA, Australia, Canada, Japan, UK, and European Union countries.
- Inspection or audit report
- Certificates (ISO, full quality certificate, CE design certificate, Declaration of conformity)
- Plant master file (as per appendix I of MDR, 2017)
- Device master file (as per appendix II of MDR, 2017)
- Label and IFU
- Establishment certificate
- Constitution details of the authorized Indian agent.
Steps to register Class B microscope in India
Step 1: Applicant needs to determine if the device falls under the category of notified micropscope medical devices, which needs registration in India as per the notification of CDSCO.
Step 2: Applicant needs to classify the Micropscope devices in a risk-based class (Class A, or B) based on the risk they have.
Step 3: Applicant must fill out the application to get permission to manufacture based on the class Form M-3 or Form MD -4 (Manufacturing loan license) or Form MD-14 to import the micropscope medical device to market it in India.
Step 4: The importer needs to appoint the Indian authorized agent, per the MDR,2017 rules, as the manufacturer’s legal representative who will look out for all the manufacturer’s official work if the manufacturer is not a resident of India.
STEP 5: Applicant needs to submit the following documents for the micropscope medical device
STEP 6: For class B, the audit of manufacturing site shall be carried out within 90 days from the date of application (this is done prior to the grant of licence).
STEP 7: State licensing authority permits the license to manufacture micropscope medical devices through Form MD-5 or Form MD – 6 (loan license to manufacture) if they are satisfied with the application; whereas in Form MD-15 to import CLA gives permission if satisfied with the applicant’s documents.
STEP 8: Market micropscope medical devices in India when it gets the green signal from the CDSCO
Conclusion: Microscope that falls in Class A Non-sterile, non-measuring, and Class B medical devices will require registration, but the documentation is as per the rules of CDSCO. CDSCO is the regulatory body of India that regulates the medical device rules and regulations and gives registration licenses to deserving applicants. The main aim of the CDSCO is to make medical devices as safe as possible for the intended population, as it directly impacts people’s health.
Download Checklist of Documents Required for Registration of Medical Devices with CDSCO
These comprehensive set of checklists are designed to help streamline the registration process and ensure that you have all the necessary documentation in place.
