Medical Device Market and Regulations in India

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. Moreover, the Indian Government expands support for medical insurance policies through continuous investment in medical infrastructure to cope with the increasing demand for basic medical care from the enormous rural population. It is estimated that that annual compound growth rate is 14.8% between 2014 and 2017 and the market size will reach USD5.64 billion, turning into one of the markets with fastest growing speed.

The market for medical devices 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 equipment and ultrasonic) account for the majority of import while the 2014 market size was approximately USD1140 million. The market demand for supporting apparatus, orthopedic and implants is also growing quickly.

Table 1 Annual Compound Growth Rate by Product Type in India

Product Type	Annual Compound Growth Rate (FY2008~FY2013)
Diagnostic Imaging Products	12.5%
Medical Consumables	14.2%
Supporting Apparatus	19.7%
Orthopedic and Implants	22.4%
Dental Products	15.4%

1. Central Health 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.

Indian Government has designed a medical device management system in the last five years and has taken active participation in global regulatory harmonization. Officers of Central Drug Standard Control Organization (CDSCO) under the Ministry of Health and industry representatives have formed the core team for Drugs Controller General of India (DCG (I)). The 2008 core team meeting submitted the resolution of discussions over medical regulations to the Indian Government for review. The team has proposed the road map for medical device regulations, which 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 13485:2003 and the IS15579:2005 developed by Bureau of Indian Standards
Management of test labs and incorporation of test results with pre-market evaluation
Reference and comparison of the clinical guidance from the GHTF Fifth Team and International Conference on Harmonization (ICH)
Applying the N54 Documents from GHTF Second Team as guidance in adverse reaction reporting
Independent category of In Vitro Diagnostic Device (IMD)
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 is stipulated that products requiring registration for drug control include the medical device in Category 14 and sterilized medical devices in Category 19.

	Device Name
	Disposable Hypodermic Syringes
	Disposable Hypodermic Needles
	Disposable Perfusion Sets
	In-vitro Diagnostic Devices for HIV, HbsAg and HCV
	Cardiac Stents
	Drug Eluting Stents

	Intra Ocular Lenses
	I.V. Cannulae
	Bone Cements
	Heart Valves
	Scalp Vein Set
	Orthopaedic Implants
	Internal Prosthetic Replacements

Table 2 Medical Devices Listed for Medical Control

	Device Name
	Spinal needles
	Insulin syringes
	Three way stop cock as an accessory if IV cannula/ catheter /perfusion sets
	Endotracheal tubes
	Introducer tubes
	Annuloplasty rings
	Cardiac patches
	Cochlear implants
	Extension tubes
	Close wound drainage sets
	Tracheostomy tube with/without cuffs
	AV fistula needles
	Extension line as a accessory of infusion sets
	ANGO kit/PTCA/cath lab kits
	Heart lung packs
	Measure volume sets
	Flow regular as a accessory of infusion sets
	Haemodialysis tubing set/blood tubing set/arterial venous tubing sets
	Dialysis catheters

Table 3 Sterilized medical devices that require registration of inspection

3. Application of Public Sales for Offshore Products:
Local manufacturers are required for conformance with Schedule M GMPs (Drugs and Cosmetics Act). Offshore suppliers in generally conform to the ISO13485, USFDA QSRs or other QMS requirement of the local countries for offshore manufacturers. 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 total system quality assurance /CE manufacturing quality system assurance /inspection certificate in CE forms in accordance with the acquisition path of CE certificate. Moreover, suppliers will need to provide one 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.

In case the particular medical device has acquired proof of public sales in U.S., Canada, Japan, EU, and Australia, a manufacturing and sales certificate will be required 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.(http://cdsco.nic.in/html/D&C_Rules_Schedule_Y.pdf) However, the Act does not have any relevant requirement on medical devices while the future proposal for Schedule M III(http://www.cdsco.nic.in/writereaddata/ScheduleM(GMP)6.pdf) will impose independent post-market requirement in addition to harmonizing with GHTF directives.

截止日期	2027/02/08