Medical Device Registration in India


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Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview

India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing

India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India

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Medical Device Registration in India

  1. 1. Medical Device Registration in India Steps to register and sell medical device in the Indian market BY : CHETAN N. UMALE Regulatory Affairs
  2. 2. Key Topics  Indian market overview  India’s medical device regulatory structure  Categories of regulated medical devices in India  No Objection Certificates  Device Registration Certificate applications  Import Licensing  India Authorized Agent selection  Costs and Timelines  Developing Regulatory Issues in India
  3. 3. Indian Market Overview Economic and demographic trends are driving medical device industry interest in the Indian market • India’s medical device market will reach $6 billion by 2015 • The number of Indian citizens over the age of 60 will reach 200 million by 2025 • “Medical tourism” attracts hundreds of thousands of visitors to India each year • A rising Indian middle class is seeing increased incidence “lifestyle diseases” such as heart disease and diabetes Imports as a percentage of India’s GDP have grown at a steady rate. 1970 – 4% 1990 – 8% 2010 – 25% Sustained Indian demand for imported goods includes medical devices. India relies on imports for about 75% of its medical device demands. Opportunity for medical device exporters!
  4. 4. India’s Medical Device Market: Import-Dependent India’s medical device market is highly dependent on imports: about 75% of the country’s demand for medical devices is met via imported products. India’s Largest Medical Device Importers US (29%) Germany (20%) Other Countries (19%) Other EU Countries (17%) China (8%) Japan (7%)
  5. 5. Longer Life Expectancies Rising life expectancy rates in India means growing demand for medical devices and health care products as more people age. 1960 – 43 1970 – 49 1980 – 55 1990 – 58 2000 – 62 2010 – 65 Healthcare Spending Increasing As India’s economy expands, health-related expenditures are also rising.
  6. 6. Indian States and Territories India has 28 states and 7 union territories, presenting potential challenges in terms of distribution of medical device. Careful selection of distribution partners is essential.
  7. 7. India’s Medical Device Regulatory Structure Ministry of Health and Welfare Drug Controller General of India (DCGI) Central Drugs Standard Control Organization (CDSCO) – Medical Devices Division
  8. 8. India’s Medical Device Regulatory Structure • India had no regulations for medical devices in place prior to 2005. • The registration process for medical devices in India remains fluid, but regulators are taking steps to develop a more formalized oversight policy. India’s Medical Device Regulatory Structure • The import, manufacturing, distribution and sale of medical devices in India are overseen by the Drugs and Cosmetics Act (1940) and Rules (1945). • 22 medical devices are currently “notified” under the Drugs & Cosmetics Act. • Controls and inspections are carried out by the CDSCO, state drug controllers and central/state laboratories.
  9. 9. Device Classification in India • No specific medical device classification currently exists in India. • Devices notified (regulated) by the Indian government must register with the CDSCO. • Non-notified devices do not require CDSCO registration, and may be imported into India according to formal customs rules.
  10. 10. Disposable hypodermic syringes Condoms Disposable hypodermic needles Tubal rings Disposable hypodermic perfusion sets Surgical dressings In vitro diagnostic devices for HIV, HBsAg and HAV Umbilical tapes Cardiac stents Blood/blood component bags Catheters Drug eluting stents Disposable hypodermic needles Intra ocular lenses Disposable hypodermic syringes Disposable hypodermic perfusion sets Intra ocular lenses IV cannulae Heart valves Bone cements Intra uterine devices Scalp vein sets Skin ligatures, sutures and staplers Orthopedic implants Blood grouping sera Internal prosthetic replacements List of Notified Medical Devices The list of medical devices notified for registration with CDSCO (as of February 2012) includes the following products:
  11. 11. No Objection Certificate (NOC) letter The DCGI will review certain product information and provide written determination on the regulatory status of a medical device 4 to 12 weeks to process applications Registration Validity and Timeframes Registration Certificates (Form 41) and Import Licenses (Form 10) are valid for 3 years Following submission of your registration application, it typically takes 6 to 9 months for CDSCO to issue the Registration Certificate It usually takes 4 to 5 weeks to obtain an Import License A provision of the Drugs & Cosmetics Act mandates inspections of overseas manufacturing sites, at a cost of US$5000 to manufacturers
  12. 12. India’s Device Registration Process Registration Checklist The following documentation is required in order to apply for medical device registration certification in India: 1. Covering Letter: states the intent of the application and lists all documents being submitted with the application 2. Authorization Letter: identifies our India Authorized Agent 3. Form 40: general medical device registration application form 4. TR6 Challan: registration fee payment--$1,500 per site, $1,000 per device 5. Power of Attorney: necessary for proof of authorization from manufacturer to India Authorized Agent; must be notarized by Indian embassy in device’s country of origin 6. Schedule DI and Plant Master File: information on device and manufacturing site(s) 7. Schedule DII and Device Master File: information on intended use, indications for use, classification and any novel features, clinical data, post-market surveillance data and other details 8. Wholesale License: permits our India Authorized Agent to act on behalf of us. 9. Free Sale Certificate (FSC): must be from device’s country of origin; an FSC from a GHTF country may also be required
  13. 13. 10. Manufacturing License: must be issued by the regulator of the device’s country of origin; also known as Establishment Registration Certificate 11. ISO 13485:2003 Certificate: must be in place for the foreign manufacturing site 12. Quality Assurance Certificate: must be in place for the foreign manufacturing site 13. CE Design Examination Certificate: must be in place for device 14. Declaration of Conformity: must be in place for device 15. Inspection/Audit Report: must be carried out by appropriate Notified Body, national regulatory authority or Competent Authority
  14. 14. Costs and Licensing Fees Requisite fees prescribed by the Drugs & Cosmetics Act for medical device registration include: $1,500 for registration of manufacturing premises $1,000 for device, plus $1,000 per additional device to be imported to India Labeling Requirements: “add on label” for India normally includes the following Imported & Marketed by: MRP: Rs. xxxx/- (incl. of all taxes). Qty: Brand name: Import Lic. No.: "For further information or any complaints or queries please visit website or call Customer care Executive at +91-xxxxxxxxxx" Imported on: mm – yyyy
  15. 15. Form 10 Import License Required of any registered medical device and non-critical IVD reagents 4 to 12 weeks to process application and issue license Rs1,000 for the first product on an import license and Rs100 for any additional products from same manufacturing site an in same Form 41 Device Family Categorizations Determining product’s Device Family is crucial for registration process in India, and for calculating associated fees will need to pay. The DCGI defines device families as follows: A group or family of devices manufactured by or for the same manufacturer, having the same basic design, performance characteristic related to the device safety, effectiveness and intended use (including variation in sizes and shapes) would be considered as one single device. Further, a device may also include a package of various devices or sub- systems that are required to be used together as a single functioning device that may include variation in size or shape without any change in material or method of use.
  16. 16. Clinical Trials in India Important: because India’s medical device regulations are currently based on the country’s drug regulations, Phase III clinical trials in India are technically required for all products notified for registration. It cannot be assumed that if product has already obtained US FDA clearance or approval, for example, will not need to conduct further clinical trials in India. Clinical trials in India may be required for device regardless of the quality of any existing clinical data may have already acquired for device in another market. Combination as well as cardiovascular devices also often require clinical trials as part of the Indian registration process.
  17. 17. India Authorized Agent Requirements Foreign manufacturers with no local presence in India must appoint India Authorized Agents to manage registration as well as post-market surveillance requirements. India Authorized Agent India Authorized Agent is a person or company responsible for device registration and liaising between manufacturer and the CDSCO’s Medical Devices Division. If device is on the list of regulated devices in India, manufacturer must appoint an India Authorized Agent to represent manufacturer. India Authorized Agent Role and Responsibilities • Must be a resident of India • Must have prior experience in the healthcare industry • Authorized through power of attorney to submit medical device registration documents to CDSCO and act as point of contact between manufacturer and CDSCO • Acts on manufacturer’s behalf in the event of an onsite inspection of manufacturer’s facility
  18. 18. • At CDSCO’s request, the India Authorized Agent provides information on the manufacturer’s device as well as designated distributors in India • The India Authorized Agent also assists with coordination of inspections if regulators select the manufacturer for an audit • The India Authorized Agent must hold Drug Wholesale Licenses 20-B and 21-B Regulatory Developments in India The Indian health ministry is planning significant changes to its regulatory approach for medical devices. Revisions will include: Defining and regulating medical devices separately from drugs Bringing ALL medical devices under regulation in India Establishing a risk-based device classification system Establishing clinical trial protocols Setting up conformity assessment procedures Increasing staff and resources at the CDSCO