FREQUENTLY ASKED QUESTIONS

FAQ'S - MEDICAL DEVICES

Frequently asked questions are for our valued customers to keep them abreast of the latest developments in the regulatory process and to help them make informed submissions and applications.

Our FAQ’s are a set of dynamic questions and we continue to update them on regular basis to keep them afresh and highly relevant to our valued customers.

1. What is a medical device?

Answer. Notified devices as per Drugs & Cosmetics Act intended for use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government, Government of India, by notification in the Official Gazette, after consultation with the Board.

2. Where can we get a copy of the Drugs & Cosmetic Act 1940 & Rules 1945?

Answer. The copy of the Drugs & Cosmetic Act 1940 & Rules 1945 can be downloaded y a customer from the following link: http://cdsco.nic.in/Drugs&CosmeticAct.pdf

3. Regulatory Authority which regulates the medical devices in India?

Answer. Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.

4. Who can be an importer of a medical device into India?

Answer. A company having wholesale license in 20B and 21B and/or manufacturing license Form 28 issued under Drugs and Cosmetics Act, 1940 and Rules 1945 can be an applicant for Registration and import of medical devices into India.

5. Registration and import license requirements for import of IVD’s in India?

Answer. Registration is not required for import of non-notified IVD’s in India. However, the following IVD’s devices are regulated as Drugs under Drugs and Cosmetics Act and Rules, hence registration and import license is required for import in to India. These devices are: Blood Grouping Sera, Testing Kits for HIV treatments, HBsAg and HCV.

6. What are the requirements for import of medical devices in India?

Answer. For import of following medical devices, the manufacturing site and (medical devices) are required to be registered with CDSCO.
i. Disposable Hypodermic Syringes
ii. Disposable Hypodermic Needles
iii. Disposable Perfusion Sets
iv. Cardiac Stents
v. Drug Eluting Stents
vi.Catheters
vii.Intra Ocular Lenses
viii. I.V. Cannulae
ix. Bone Cements
x. Heart Valves
xi. Scalp Vein Set
xii. Orthopedic Implants
xiii. Internal Prosthetic Replacements
xiv. Ligatures, Sutures, Staples
xv. Intra Uterine Devices (Cu-T)
xvi. Condoms
xvii. Tubal Rings
xviiii. Surgical Dressing
xix. Umbilical Tapes
xx. Blood / Blood Component Bags

These devices covered under Drugs & Cosmetics Act 1940 & Rules 1945 need to submit the application in Form 40 with Schedule D (I), D(II), Power of Attorney forms, Plant Master File, Device Master File, Regulatory Certificates and Free Sale Certificate from either USA, Canada, Japan, Australia or EU along with the prescribed fee.

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