What is Medical Device Manufacturing and Importer License?
All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) disinfection of medical devices; and
(vi) control of conception
Why this License is Required?
The standards of quality and safety of medical devices are regulated in India by a law called The Drugs and Cosmetics Act, 1940 (“DCA”). … The way DCA and MDR ensure quality and safety of notified medical devices at all levels of the supply chain is by enforcing a mandatory license requirement.
Check out the Medical Device Manufacturing and Importer License Video
Who can get a Medical Device Manufacturing and Importer License
Medical Devices
Disposable Hypodermic Syringes
Disposable Hypodermic Needles
Disposable Perfusion Sets
Vitro diagnosis
Cardiac Stents
Drug Eluting Stents
Catheters
Intra Ocular Lenses
I.V. Cannulae
Bone Cements
Heart Valves
Scalp Vein Set
Orthopedic Implants
Ablation Devices
Tubal Rings
Document Required for Medical Device Manufacturing and Importer License
- Name of the company or firm or any other entity importing/Manufacturing the medical device, specification and standards of the particular medical device.
- Details of medical device/IVD Medical Devices.
- Certificate of compliance with respect to ISO 13485 standard accredited by the National Accreditation Board for Certification. Bodies or International Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device.
- Free Sale Certificate (FSC) from Country of Origin in case Imported Medical Devices.
- Undertaking signed by the importer/Manufacturer stating the information provided by the applicant is true.
- Product Technical File
- Plant File
Role of Shamkris and Process of Medical Device Manufacturing and Importer License
Shamkris adopts a results-oriented approach to compliance with mandatory licence requirements in the organization. A simple and guidance methodology help organisation to achieve licence in a timely manner and cost-effective. Shamkris support 100% in advisory, Guidance, Compliance with respect to license requirements to obtain approval.
The License process described below:
- Advisory for the document required
- Preparation of documents as per application & list of documents.
- Application File
- Inspection by the department if required
- Liason department
- Yearly Compliance if Applicable
- Renewal when due
Who can issue the Medical Device Manufacturing and Importer License?
Application for registration is submitted to the Drugs Controller General of India. Necessary documents mandatory to acquire license permit: Granting license for manufacturing of medical devices requires filling Form-28 along with prescribed government fees in the form and manner as prescribed by the Act.
An application for an import License shall be made to the licensing authority in Form 8 for drugs excluding Schedule X, and in Form 8-A for Schedule X drugs; either by the Manufacturer or by the Manufacturer’s agent in India who is having the wholesale license for sale or distribution of drugs and shall be accompanied .
According to the World Health Organization, medical devices are essential for safe and effective prevention, diagnosis, treatment, and rehabilitation of illness and disease.
As for drugs, mislabelling of medical devices can result in serious consequences for the user. It is important, therefore, that medical device marketing and advertising are regulated to prevent misrepresentation of a medical device and its performance.