國家科學及技術委員會新竹科學園區管理局

The total population of India reached approximately 1,290 million people in 2015, the world's second largest population after China. In spite of the majority consisting of rural population in poverty, India’s economy has recently transformed and agreed to open to foreign investment, contributing to the annually increasing economic indicators and numerous middle class. It is estimated that annual compound growth rate is 14.8% between 2014 and 2017, turning into one of the markets with fastest growing speed.

The market for medical device in India is in the beginning stage while import of medical device accounts for 75% of the overall market. Due to the increase in demand for local medical bodies and hardware facilities, diagnostic imaging products (e.g. electrical instruments, x-ray and ultrasonic equipment) account for the majority of import. The market demand for assistive devices, orthopedic and implants is also growing quickly.

1. Competent Authority:

Currently the medical devices in India comply with Drugs and Cosmetic Act and consolidated in drug management. The governing institution is the Ministry of Health / Central Drugs Standards Control Organization (CDSCO), in compliance with the following laws and regulations.

• Drugs and Cosmetics Act - ACT No. 23 of 1940
• Guidelines for Import Registration and Manufacture of MD, 2007; Medical Device Notification 2007 (GSR 623 E)

CDSCO has designed a medical device management system in the last five years and has taken active participation in global regulatory harmonization. The road map for medical device regulations, includes the review on existing status, principles of guidance, suggestions provided by industries, and the placement method of regulations in different phases, including: 

• Definition and rules for trends toward GHTF
• Product risk classification from low to high, dividing into four categories from A to D
• Approval for third-party audit
• Reference with ISO 13485 and the ISO 15579:2005 developed by Bureau of India Standards
• Management of test labs and incorporation of test results with pre-market evaluation
• Reference and comparison of the clinical guidance from the GHTF and International Conference on Harmonization (ICH)
• Applying the N54 Documents from GHTF as guidance in adverse reaction reporting
• Independent category of In Vitro Diagnostic Device (IVD)
• Improvement on piracy issues of medical devices, import duties and annual fees for registration

2.  Category and Classification:

Currently the medical device in India is unclassified or not categorized. In the 2006 revision of Drugs and Cosmetics Act, it regulated 14 medical devices listed as drugs and 19 sterilized medical devices that required registration.

• Medical Devices Listed as Drugs

1. Disposable Hypodermic Syringes

2. Disposable Hypodermic Needles

3. Disposable Perfusion Sets

4. In-vitro Diagnostic Devices for HIV, HbsAg and HCV

5. Cardiac Stents

6. Drug Eluting Stents

7. Catheters

8. Intra Ocular Lenses

9. I.V. Cannulae

10. Bone Cements

11. Heart Valves

12. Scalp Vein Set

13. Orthopaedic Implants

14. Internal Prosthetic Replacements

• Sterilized medical devices that require registration
  

1. Spinal needles

2. Insulin syringes

3. Three way stop cock as an accessory if IV cannula/ catheter /perfusion sets

4. Endotracheal tubes

5. Introducer tubes

6. Annuloplasty rings

7. Cardiac patches

8. Cochlear implants

9. Extension tubes

10. Close wound drainage sets

11. Tracheostomy tube with/without cuffs

12. AV fistula needles

13. Extension line as a accessory of infusion sets

14. ANGO kit/PTCA/cath lab kits

15. Heart lung packs

16. Measure volume sets

17. Flow regular as a accessory of infusion sets

18. Haemodialysis tubing set/blood tubing set/arterial venous tubing sets

19. Dialysis catheters

3. Application of Distribution of Import Products: 

Local manufacturers are required for conformance with Schedule M GMPs (Drugs and Cosmetics Act). Foreign manufacturer should conform to ISO13485, USFDA QSRs or other QMS requirement of the local countries. The registration directives announced in 2013 describes the requirement for acquiring the registration certificate for inspection (Form 41) and import license (Form 10) in order to sell medical devices in local India. The suppliers also need to provide copies of ISO13485 certificate and CE certificate with system quality assurance. Moreover, suppliers will need to provide audit report from the local health competent authority and third-party certification body. In the application process, Plant Master File is often used to replace the Quality Manual.

For medical device that has acquired certificate of U.S., Canada, Japan, EU, and Australia, it should be provide free sale certificate with description of the name and address of legal representative of manufacturer and the actual manufacturer. The review process will be accelerated since the acquisition of certification suggesting the medical device is of good quality and  under regulatory control. In the future, the CDSCO will also adopt electronic submission of documents for document review.

4.  Post-market recall reporting:

Drugs and Cosmetics Act mentions relevant requirements on complaints and adverse reaction reporting, with stipulation on drug requirement in Schedule M (GMPs) and on new drug clinical test in Schedule Y. However, the Act does not have any relevant requirement on medical device while the future proposal for Schedule M III will impose independent post-market requirement in addition to harmonizing with GHTF directives.

出處與延伸閱讀

1. 2015醫療器材產業年鑑
2 .http://cdsco.nic.in/Medical_div/Final%20Guidance_Doc_RC_31-10-2012.pdf