Medical Devices Registration

The central drugs and standard control organization (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare, and Government of India is the National Regulatory Authority (NRA) of India.

Under the Drugs and Cosmetic Act, CDSCO has many responsibilities which include approval of Drugs to direct clinical trials, Providing standards for drugs, quality check imported drugs in the country, and coordinating with the state drug control organization for the activities by providing expert advice, training keeping in mind the uniformity in the implementation of the Drugs and Cosmetic act.

Also, CDSCO regulates the manufacturing and import of medical devices in India. As per the Drug and Cosmetic Act, medical devices are categorized under the category of drugs.

Role of Central Drug Standard Control Organization:

Under the Drug and Cosmetic Act, the arrangement of manufacture, sale, and distribution of Drugs, medical devices,s, and cosmetics is firstly the priority of state authorities while central authorities are only responsible for giving permission to new drugs, clinical experiments in the country, providing standards for drugs, to check the quality of the imported drugs, coordinating with the state authorities.

CDSCO is also a part of giving permission to specified categories of drugs such as blood and blood products, I.V Fluids, Vaccines

What is a Medical Devices?

According to the latest definition as provided under the Medical Devices Amendment rules 2020, as notified on 11.02.2020. However, taking care of circumstances the government has exercised its powers to include more categories by widening the scope of the definition of “Medical Device” under the Act. It states-

"Devices used in general medical practice such as medical apparatus, instruments, implants appliance, etc., which are either used individually or in combination, and are intended to be specifically applied for human beings or animals and are further intended to obtain the desired function by such means and for such purposes as provided below, but is not intended to meet the primary intended action on human body or animals by any pharmacological or immunological or metabolic means-  

• Analysis, prevention, observation, treatment, or mitigation of any disease or disorder;
• Analysis, observation, treatment, mitigation, or support for any injury or disability;
• Examination, replacement or alteration or support in findings of the anatomy or a physiological process;
• For supporting or sustaining life;
• Decontamination of medical devices; and
• Conception-related equipment & devices.

Therefore, every manufacturer or importer or both of any medical devices in India shall be required to obtain registration as per the provisions of the Drugs and Cosmetics Act 1940. Any failure to comply with the same may invite legal action including penalty & prosecution under the Act.

Moreover, CDSCO along with state drug control organizations is together responsible for the permit of a license of certain specialized types of critical drugs.

Any entity willing to manufacture or import medical devices in India as specified under notified or non-notified medical devices list published by Central Drug Standard Control Organisation (CDSCO).

Provisions related to the import, manufacture, sale & distribution of medical devices are regulated under the provisions of the drug and cosmetics Act 1945. Under the New Medical Rules 2017, all medical devices have been classified into four different categories depending on their usability & risk involved as provided below. 

• Class A -Low-risk devices like a thermometer, tongue depressors, etc.
• Class B- Low moderate risk like Hypodermic Needles, suction equipment, etc.
• Class C- Moderate high-risk devices like Lung ventilator, etc.
• Class D- High-risk devices like Heart valves, implantable devices, etc.

Where Class A&B devices are considered to be less risky and moderate devices, for which the application to manufacture has to be filed to the State Licensing Authority. Whereas Class C &D are considered to be high and very High-risk devices and the application for these has to be filed to the Central Licensing Authority of India.

The provisions related to activities such as Import, manufacture, sale and distribution of medical devices have been regulated under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. Therefore, any person/firm/enterprise, etc. holding a wholesale drug license and/or manufacturing license issued under the Drugs and Cosmetics Act, 1940 and Rules 1945 could make an application for Registration and import of medical devices into India.

Any Indian entity willing to manufacture or import medical devices specified under the notified list of 37 medical devices has to undergo the CDSCO registration.

There are various forms specified for each type of license that the applicant is opting for as per its business requirement. The list of application forms are mentioned below

• Importer: Any Indian entity willing to import medical devices from a foreign manufacturer needs to apply for CDSCO import license under MD-14 application form.
• Manufacturer: An Indian entity willing to manufacture and further sell medical devices in India needs to apply for CDSCO medical device manufacturing license under Form MD-3 or Form MD-7.

The benefits of Medical Devices registration are as follows-

• Heavy demands

Many medical device manufacturers from around the world do business in India, making it one of the largest marketplaces. To cater to these demands, the latter relies heavily on those, who come from overseas. Also, the opportunities offered to them are highly lucrative and cannot be ignored. For instance, the authority in charge is not willing to bear the brunt of the excessive medical devices, avoiding any risks or trade-offs performed. And that is how the regulatory body caters to the same. 

• Ensures patient safety

Unquestionably, patient safety is of the utmost significance and cannot be compromised. This can be achieved by using high-quality medical devices or by rechecking whether products are 100% operationally efficient or not. Make sure it is free from any risks or potential harm that it may silently cause. 

• Opportunities for the manufacturers overseas

It is noted that the demand for medical devices has skyrocketed in the market, which makes India push its boundaries, inviting growth. In this manner, it unlocks new doors of opportunities, enabling them to procure CDSCO’s permission in undertaking the shipments for the medical services as per the informed specifications. Yes, it might be difficult to obtain the import license, however, it is not impossible to get the same, until your profit margins soar high.

• Form 40
• ISO 13485 certificate
• Full Quality Assurance Certificate
• CE Design Certificate
• Undertaking that all information provided is authentic
• Either a Free Sale Certificate or Certificate from the Foreign Government 
• Certificate of Marketability from GHTF (Australia, Canada, Japan, the European Union, and the United States);
• Plant Master Report
• Device Master File

1. Determine Whether Your Medical Device is under Notified List or Not

The CDSCO authority has provided a list of notified medical devices that need to compulsorily obtain registration under the Drugs and Cosmetics Act 1940 and in accordance with Medical devices rules 2017. However, there may be any medical devices that have not been expressly notified by the CDSCO authority, or in case of new medical equipment, the manufacturer/importer shall be required to obtain a NOC in such cases. For instance, Blood Grouping Sera Ligatures, Sutures, Staples Intra-Uterine Devices (Cu-T), Condoms, Tubal Rings, Surgical Dressing, Umbilical Tapes, Blood / Blood Component Bags do not need registration, whereas devices such as spinal needles, cochlear implants, syringes, and needles, heart valves, endotracheal tubes and catheters among others should undergo registration provides with the CDSCO.

2. Appoint an Authorized Representative (in case of Foreign Entity)

For a foreign business manufacturer entity, it shall be necessary to appoint an authorized business entity in India, who shall be the contact person for the inspection authorities during the process, assist in device approvals, and registrations process, and vigilance adverse event reporting. The Indian Authorization should hold a wholesale drug license in forms 20B& 21B.

3. Fill out the Applicable Form for Medical Device Registration

In the next step, the manufacturer/importer for MD shall be required to submit the registration form of a regulatory dossier, along with all the prescribed documents along with the prescribed fee on the CDSCO portal to the DGCI (Drugs Controller General of India) by logging on to the online CDSCO portal https://cdsco.gov.in/opencms/opencms/en/Home/ and signing into the portal.

4. Obtain Certificate of Registration in Prescribed Form 

Once the application is submitted on the CDSCO portal, the DGCI registration authority may send a query through an inquiry letter to the manufacturer or from the authorized representative of the importer, along with the timeline within which the query should be answered and sometimes, may also ask for a technical presentation On satisfaction the authority may issue a license in such form as provided in the above list. After obtaining registration, the manufacturer or his authorized representative may apply for an importer license.

Applicable Fees for Each License Type:

Further, each application shall be supported with the list of documents and the requisite fee as provided in the online portal of CDSCO-

Time Involved & Validity for Registration

If the DGCI doesn’t ask for a Technical Presentation or Subject Expert Committee (SEC) audit, it takes around 6-9 months to obtain a Medical Devices Registration. In cases where Technical Presentation or Subject Expert Committee (SEC) audit is required, it may take additional 3-6 months. 

Once obtained the Registration Certificate shall be valid for a total period of 3 years from the date of issue of registration unless suspended or canceled by the DGCI authority for proper causes.

Re-registration or Renewal of the Registration Certificate

The application for renewal of the MD registration certificate shall be made at least nine months from the expiry of the registration certificate. Though there are no additional requirements for the renewal of registration, it shall be necessary for the certificate holder to provide a copy of the Plant Master File (PMF) and Device Master File (DMF), where there are no changes in the PMF and DMF, 

Post-Compliances After Receiving Registration

Though there are not many compliances in place about the registration certificate, it shall be compulsory for the certificate holder to-

• In case of any change that has taken place about the constitution of the firm and/or address of the registered office/factory premises, the MD manufacturer/authorized representative of the importer to intimate the licensing authority regarding the same in writing;
• In case any such change has taken place, the existing registration certificate shall be valid for a maximum period of three months from the date on which the change has taken place, and during this time, the manufacturer/authorized representative shall be required to obtain a fresh Registration Certificate; 

Corpseed being a single-stop solution service facilitate ensures a hassle-free registration for CDSCO. We at Corpseed facilitate end-to-end solutions for all Indian Regulatory compliance.

• Free consultation on the applicability of medical device under medical device rules 2017
• Assistance in preparing and managing documents
• Application filling
• Liasioning with the department officials on behalf of the applicant
• Timely approval in predefined ETA
• Quality service with minimum charges.